Planet Pharma

Lead multiple concurrent projects related to label, IFU, and packaging changes in production, managing a team of 15-20 members and ensuring projects are delivered on time and within budget. | 10 years of project management experience, proficiency in MS Project, experience in the medical device production environment, and proven leadership managing large teams and budgets. | Posted: 09/26/2025 Employment Type: Contract Job Category: Project Management Job Number: 622708 Is job remote?: Yes Country: United States Job Description Pay 45-58/h depending on experience HM's Top Needs: 1. Has worked in the Medical Device space 2. Is proficient in MS Project 3. Proven track record of delivering his/her projects on time and within budget. The focus of this Project Manager position will be on the implementation activities related to label, IFU, and packaging changes within our production environment. We expect the Project Manager to lead 5 to 7 projects concurrently. The ideal candidate should have experience in the Medical Device space, particularly in the production of these devices. The Project Manager will lead a team of approximately 15 to 20 team members in various areas of the business. The candidate should have a proven track record of delivering his/her projects on time and within budget. Years’ Experience Required: 10 Responsibilities may include the following and other duties may be assigned. Oversees and manages the operational aspects of ongoing projects and serves as liaison between project management and planning, project team, and line management. Reviews status of projects and budgets, manages schedules, and prepares status reports. Assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction goals and objectives. Develops mechanisms for monitoring project progress and for intervention and problem solving with project managers, line managers, clients and other stakeholders. PEOPLE MANAGEMENT FUNCTIONAL CAREER STREAM: Management and supervisory professionals with one or more employees who are focused on tactical, operational and some strategic activities within a specified area. Levels within the management career stream typically have six or more direct reports. The majority of time is spent overseeing their area of responsibility, managing performance, developing talent, engagement and inclusion, communicating business and operational developments, planning, prioritizing and / or directing the responsibilities of direct reports. Goal achievement is typically accomplished through performance of direct and / or indirect reports. A key responsibility of roles in this career stream is managing people. which includes: accountability for mentoring, developing and coaching staff on meeting/exceeding performance expectations and defined objectives, providing leadership to staff ensuring the prioritization of strategic and department level initiatives to include defining performance goals and targets, conducting performance reviews, and staff 1:1s to guide performance management and employee development efforts and manage toward departmental goals. DIFFERENTIATING FACTORS Autonomy: Manages subordinate supervisors and/or experienced professionals who exercise latitude and independence in assignments. Provides tactical and / or operational leadership and coaching. Receives assignments in task and objective oriented terms. Organizational Impact: Establishes operational plans and implements policies and strategies. Decisions impact program schedules, customer satisfaction levels, or allocation of time, material resources, expenditures and funds. May have budget or P&L accountability for a department, function or geography. Strive for continuous improvement and consistency in deliverables. Innovation and Complexity: Proposes modifications to functional operating policies and day-to-day processes. Problems and issues faced are complex, difficult and undefined, and require detailed information gathering, analysis and investigation to understand the problem. Communication and Influence: Communicates with internal and external customers and vendors regarding ongoing operations. Uses information exchange, influence and active persuasion without direct exercise of command to gain cooperation of other parties . May interact on issues that have externally shared objectives. Leadership and Talent Management: Manages a team consisting of supervisors and / or experienced professionals in the Specialist career stream. Leads, directs and reviews the work of a team who exercise latitude and independence in their assignments. Authorizes hiring, firing, promotion and reward within own area. Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes, projects and tactics within one job area. Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization. Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Ensure cGMP and FDA quality system compliance through validation documentation review, testing, reporting, and corrective action management in donor center and manufacturing environments. | Bachelor's degree, strong knowledge of cGMP and SOPs, excellent analytical and communication skills, ability to work in lab/manufacturing settings with PPE. | Job Description Summary: Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review and approval of validation and quality assurance/control documentation. Primary Responsibilities of role:? Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment validation. ? Assures compliance with SOPs upon implementation. Investigates and proposes additional corrective actions as required. ? Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. ? Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: ? Write test cases to validate critical control points, user requirements, and functional designs. ? Execute test cases as needed. ? Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use." ? Assists in analyzing validation data to ensure acceptance criteria are met. ? Assists in writing validation summaries. ? Ensure milestones and timelines are met on assigned projects. ? Prepares validation reports for distribution. ? Evaluates adequacy of corrective actions. ? Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: ? Prepares validation equipment for use at the Donor Center and for evaluation upon return. ? Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment, including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service." ? Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes." ? Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes." ? Monitors and trends customer complaints and nonconformance related to equipment failures.Knowledge, skills, and abilities: • Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. • Excellent quantitative and analytical skills. • Excellent oral and written communication skills. • Strong critical thinking and problem solving skills. • Ability to identify errors and provide corrective action. • Ability to work with others in a team environment. • Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. Education Requirements: • Bachelor's degree Occupational Demands: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay Rate Range: $30-50/hr depending on experience Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements. Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.

Manage CDMO performance, develop and maintain project timelines, coordinate meetings, communicate with stakeholders, manage budgets and vendor invoices, mitigate risks, and maintain project documentation. | Bachelor's degree or equivalent, 5+ years pharma/biotech experience with 3+ years CMC project management, strong organizational and communication skills, proficiency in MS Office, SharePoint, Smartsheet, and knowledge of regulatory requirements preferred. | Title- CMC Project Manager Location- Remote- Must reside in one of the following states: WA, NM, SD, TX, IN, SC, NC, PA, NY, NH, NE, NJ, KY, MA We are seeking a CMC project manager, reporting to the Associate Director, Technical Product Leadership, to support our CDMO and clinical trial activities. If you are a highly motivated and experienced CMC project management professional passionate about developing innovative cell therapies, we encourage you to apply for this exciting opportunity to join our team. KEY RESPONSIBILITIES To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • CDMO Oversight: Manage CDMO performance, ensuring adherence to service and quality agreements, execution of SOWs and organizing performance discussions • Timeline Management: Develop and maintain project timelines, ensuring all milestones are met according to project requirements. • Meeting Coordination: Schedule and facilitate project meetings, including setting agendas, preparing materials, taking accurate meeting minutes, and distributing them to relevant stakeholders. • Communication: Serve as the primary point of contact for project-related communication between internal teams, external vendors, and stakeholders. • Finance Management: Responsible for developing and managing budgets, as well as reviewing and approving vendor invoices to ensure financial accuracy and compliance with organizational policies. • Risk Management: Identify and mitigate project risks, escalating issues as necessary to ensure timely resolution. • Document Management: Maintain accurate and up-to-date project documentation, including project plans, status reports, and other relevant materials. • Performs other duties as assigned QUALIFICATIONS AND EDUCATION • Bachelor's degree in a related field (e.g., Project Management, Engineering, Life Sciences) or equivalent experience • 5+ years of experience in a pharmaceutical or biotechnology setting with 3+ years of CMC project management • Strong organizational and time management skills, with the ability to prioritize tasks effectively • Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams • Proficiency in Microsoft Office Suite, SharePoint, and Smartsheet • Knowledge of regulatory requirements related to pharmaceutical or biotechnology projects is preferred • PMP certification or equivalent is a plus • Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met • Must have strong attention to detail and demonstrated decision making ability • Ability to work individually and in a team environment • Demonstrated excellence in written and verbal communication skills • Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships •

Manage document and training lifecycle processes including collaboration with vendors, monitoring controlled document reviews, training assignments, and supporting quality inspections in a hybrid environment. | Bachelor’s degree with 2-5 years quality experience in pharmaceutical or regulated industry, knowledge of CGMP/GDP and FDA guidelines, strong communication, organizational and interpersonal skills. | The Quality Assurance Specialist position is responsible for Document and Training Management Programs. This will require working with our external Safety Data Sheet Vendor, monitoring the periodic review process for controlled documents, supporting day to day activities associated with the document lifecycle, monitoring training, performing annual training assessments and supporting the change control, batch review and new product launch activities, as needed. Previous experience with document or training management in a CGMP environment is a plus. This is a Chicgo-based hybrid role. Essential Duties include the following. Other duties may be assigned. • Responsible for Administration of Document Management Process oWorks in collaboration with Safety Data Sheet Vendor and contract manufacturing partners to obtain necessary documents for vendor to develop Safety Data Sheets. oInitiates, processes and monitors Controlled Documents within TrackWise Ditigal System including but not limited to Policies, Procedures, Work Instructions and Safety Data Sheets. oFormats red-lined or updated Controlled Documents in collaboration with document owners, as necessary oMonitors Controlled Document periodic review cycle updates and works in collaboration with Document Owners, external vendors, and partners, as applicable, to meet review timelines. • Responsible for Administration of Training Management Process for all departments. oCreates new and updates exsisting Training Plans in TrackWise Digital in collaboration with department management. oCreates on the Job Training in TrackWise Digital in collaboration with department management, as needed. oCreates Training Quizzes in TrackWise Digital, in collaboration with document or training owners, as needed. oAssigns training within TrackWise Digital system to new employees and exsisting employees, as needed. oMonitors employees training to completion ensuring training timelines are met. oPrepares and Presents Annual CGMP presentation in collabration with other Quality team members. oConducts Annual Training Assessment. oConducts New Employee Training for TrackWise Digital, Adobe Sign, and Master Product Portal. oPrepares training metrics for Management Review. • Supports management during external inspections. • Remains current in regulatory trends and requirements. • Other duties as assigned. • Strong organization skills and attention to detail is a requirement. Competencies "• Code of Federal Regulations and cGMP’s • Strong written and oral communications skills • Planning and Organizing • Interpersonal • Teamwork • Problem Solving • Quality Management • Judgement • Dependability • Ethics" To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. • Bachelor’s degree in science or equivalent degree. • 2-5 years’ experience in Quality with a pharmaceutical company or similarly regulated industry. • Knowledge of CGMP and GDP as well as FDA trends and guidelines. • Strong interpersonal skills required. • Must be a team player with good problem solving and good verbal and written communication skills. • Must be able to handle multiple projects concurrently. • Ability to manage indirect relationships and projects successfully. • Strong organization skills and attention to detail required. Travel No travel required. Computer Skills Microsoft Word, PowerPoint, Excel, TrackWise Digital, Adobe Sign preferred but not required Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee may have to sit for prolonged perids, stand and walk occasionally while in ofice. The employee is frequently required to talk or hear. Work Environment The noise level in the work environment is usually moderate. AAP/EEO Statement Equal Opportunity Employer Minorities/Women/Veterans/Disabled.

Conduct and report on monitoring visits at investigational sites, manage study compliance and documentation, train site personnel, and assist in study management and recruitment. | Bachelor's degree in science/medical field, 5-7 years CRA experience in CRO or pharma, knowledge of ICH-GCP, excellent communication and leadership skills, and willingness to travel up to 75%. | • 20 hours a week (Part-time) • Oncology experience required JOB DESCRIPTION / SUMMARY This role will ensure studies are monitored in accordance with the clinical protocol, standard operating procedures, good clinical practices, and other applicable regulatory requirements. May be responsible for multiple projects and must have the ability to work both independently and in a team environment. RESPONSIBILITIES • The main responsibilities of this role include, but are not limited to, the following:Independently conduct monitoring visits at investigational sites, including site evaluation, initiation, interim, motivational (as applicable) and close-out visits. • Prepare and submit monitoring visit reports in accordance with InClin SOPs.Conduct co-monitoring visits at investigational sites, as needed. • May function as a Lead CRA (LCRA) and may assist the Project Manager as follows: • o Development of Clinical Monitoring Plan o Tracking compliance with Clinical Monitoring Plan o Oversight and management of other CRAs assigned to the project o Review trip reports and ensure CRA compliance with CMP o May lead CRA team calls, keep minutes of those calls, and submit those minutes for filing in the eTMF. o Systems testing (i.e. eCRF and edit check UATs)Obtain, collate, and file essential clinical documents in accordance with InClin SOPs. • Communicate project-specific information to and from trial sites and document communications with study site and team. • Escalate and triage issues to team in a timely manner. • Manage key study parameters including, but not limited to, clinical study start-up activities, clinical supplies preparation, enrollment, data collection, and close-out. • Train investigational site personnel to the clinical protocol and protocol-related plans, manuals, and guidance documents as well as industry standards including ICH-GCP. • Train investigational site personnel on any study-specific portals or vendors, if applicable. • Verify study data on source documentation and case report forms per ALCOA-C standards to ensure compliance with the study protocol and study-related plans, manuals, and guidance documents. • Identify and resolve data discrepancies. • Assist in the preparation and review of study documents including, but not limited to, clinical protocols and amendments, case report forms, informed consent forms, site training materials and clinical study reports. • Organize and present at project meetings. • Provide feedback, if applicable, on monitoring strategy, study enrollment strategies, and clinical monitoring plan. • Participate in reviews of study systems testing as requested by LCRA/PM. • Review data listings as requested by LCRA/PM. • Reconciliation of pharmacy/drug accountability (unless functioning as a blinded CRA). • Serve as a mentor to junior CRAs and participates in co-monitoring activities. • Assist in site identification, patient recruitment and planning. • Collaborate with Study Management Team to drive patient recruitment. EDUCATION AND EXPERIENCE REQUIREMENTS • Bachelor's degree or equivalent experience in relevant field (science, nursing, medical or pharmacy degree required) • At least 5 – 7 years previous CRA experience in a CRO or biotech/pharmaceutical industry. KNOWLEDGE & SKILL REQUIREMENTS • Knowledge of applicable standards, regulations and ICH-GCP for clinical study conduct • Excellent oral and written communication skills • Confident and influential approach • Understanding of the needs of others • Experience of coordinating people and time management • Excellent planning, organizing, interpersonal and leadership skills with a high degree of accuracy and attention to detail • Demonstrated experience in computer skills including Microsoft Word, Excel, and basic templates • Making independent choices and to take responsibility for own actions • Recognizing potential obstacles and working to resolve them within set timelines • Being conscientious and precise in the delivery of work even when under pressure ? Being collaborative and team-oriented • Willingness to travel up to 75% of the time • Willingness to be compliant with study-specific billing and budgetary constraints