Pfizer

Compensation

Full Description

Use Your Power for Purpose In this role at Pfizer, you will have an impactful role in improving patients' lives by ensuring our practices adhere to the highest standards of compliance and ethics. Your expertise will help us maintain our commitment to patient safety and regulatory excellence. What You Will Achieve The Inspection Management Team Lead supports Pfizer by (as required) preparing for, organizing and leading Good Clinical Practice (GCP), Good Laboratory Practices (GLP) and Pharmacovigilance (PV) inspections (sponsor, investigator site, vendor, as appropriate) conducted by global Health Authorities/Regulatory Authorities (HAs/RAs), and pharmacovigilance audits conducted by license partners (LP), as appropriate. In addition, the Inspection Management Team Lead coordinates Pfizer responses to such inspections and LP audits, strategizing with stakeholders and legal and guiding the functional teams to ensure optimal responses. The Inspection Management Team Lead acts as a RQA sponsor/lead in cross-functional projects, as appropriate. This role leads and develops a team of high performing Inspection Management Leads and ensures that quality standards are consistently applied across all inspections and LP audits. The Inspection Management Team Lead helps guide, develop, and mentor Inspection Management Leads to facilitate their growth of talent. The Inspection Management Team Lead is knowledgeable with current regulatory/health authority trends and brings a unique understanding/perspective relative to regulatory/compliance investigations. The Inspection Management Team Lead serves as the delegate of the Head of Inspection Management. Role Responsibilities Leadership • Collaborates with business stakeholders, including senior business leaders, to instill a culture of regulatory compliance and ensures effective and efficient management of inspection activities • Interfaces with functional groups within RQA and customers to build knowledge of GCP/PV/GLP regulations and guidelines, and routinely engages in influencing the external environment through appropriate RQA activities (e.g. review of guidelines) • Builds effective customer relationships across stakeholders and business lines • Holds their team accountable for responsibilities • Drives team excellence by initiating and investing in development to build a stronger and more capable organization • Responsible for performance management • Strengthens group business acumen by providing opportunities to analyze and solve strategic business issues • Provides appropriate ongoing support to ensure that current talent develops the skills necessary to be high performing RQA professionals Risk/Quality Management • Monitors trends in health authority inspection activities to proactively identify potential areas of risk for Pfizer • Ensures awareness of external trends from regulators & competitors are clearly identified and proactively assessed and followed through on for Pfizer • Acts as a strategic partner by proactively identifying risks and challenges with regards to inspection findings • Represents Pfizer in external meetings and conferences as required • Evaluates inspection reports from various sources (e.g., HAs/RAs, other Pfizer quality groups) to identify issues of potential significance Operational Excellence: • Partners with other RQA Inspection Management Leads, Portfolio Team Leads, PCO Regional Team Leads, and quality/compliance/inspection readiness colleagues in the BUs/RUs/Platform Lines for activities related to inspection preparation; Activities include but are not limited to preparation of relevant materials and conducting inspection-related training (e.g., inspection interview technique) • Leads pre-inspection visits of investigator sites • Leads and/or supports management of local or global HA/RA inspections (GCP/GPvP, GLP as appropriate) and ensures that roles and responsibilities are defined and assigned for each inspection; Assumes a leadership role or other supportive roles during the inspection as required • Leads and/or supports management of local or global LP audits; Assumes a leadership role or other supportive roles during the audit as required • Lead the control room in any inspection/LP audit and serve as the note taker as required • Works with members of the inspection team and other colleagues (including, but not limited to, Head of Inspection Management, Head of RQA and Legal) to ensure optimum responses are provided to address and resolve inspection/LP audit findings, approving all responses for Pfizer prior to submission • Provides guidance to parties regarding the completion of inspection corrective and preventative action plans (CAPAs) • Leads the preparation, conduct and management of mock inspections, as appropriate • Develops and maintains policies, standard operating procedures (SOPs), tools, and guidelines as appropriate for preparation and conduct of inspections within Pfizer • Prepares periodic summary reports related to Pfizer inspections • Serves as a consultant to quality/compliance/inspection readiness colleagues for inspection-related activities • Ensures that global contact lists, report distribution lists, and tracking lists used for inspection-related activities are updated and maintained • Assists in identifying needs for updates to training materials, inspection readiness modules and documents required for the inspection readiness program • Maintains high level of expertise in international GCP/GPvP/GLP regulatory requirements, and policies, SOPs and project- specific procedures within Pfizer applicable to the clinical trial methodology and pharmacovigilance processes • Engages in and supports the activities of the relevant RQA initiatives (as appropriate) to ensure alignment in interpretation and dissemination of applicable regulations, guidance, and Pfizer policies and procedures to customers and stakeholders • Leads complex projects to drive inspection management strategies, policies and direction for Pfizer • Works with RQA functional lines and key customers to understand stakeholder needs • Works to ensure that quality standards are consistently applied across inspections • Serve as RQA participant and/or leader for cross functional GxP projects related to integration of acquired companies People Management • Provides support and mentorship to direct reports to ensure that inspection activities are consistently executed and quality standards are maintained across RQ • Provides current, direct, complete and actionable positive and corrective feedback to others • Clearly assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and results, designs feedback loops into work • Grows others by providing challenging and stretching tasks and assignments • Is aware of each direct report’s career goals, mutually constructs compelling development plans and executes them • Pushes people to accept developmental moves, will take on those who need help and further development • Undertakes leadership to provide appropriate support and guidance to the inspection team, motivates the team through deliverable / goal-setting, ongoing feedback and formal evaluation • Provides leadership and direction to the Inspection Management colleagues through appropriate education, mentoring, and training Here Is What You Need (Minimum Requirements) • Bachelor’s degree is required. Advanced academic qualification/degree is preferred; equivalent relevant professional experience will be considered • At least 10 years of relevant experience in clinical or pharmacovigilance QA, or other clinical quality management/QC role in biomedical science, clinical development, regulatory compliance, including 4+ years of direct inspection experience • 5+ years in a management role with proven accountability, and demonstrated excellent interpersonal, communication, negotiation, influencing, and problem-solving capabilities • Highly experienced and has proven ability in enterprise leadership and execution of business practices • Adept in strategic resource management • Demonstrates expert knowledge of ICH GCP, PV, and clinical research regulatory landscape, and of the principles of quality assurance • Demonstrates advanced critical thinking capabilities (e.g. synthesize key insights and complex problems clearly and precisely, infer important implications and consequences, use deductive reasoning consistently and with ease to drive effective solutions or programs) • Demonstrated knowledge of the inspection / inspectorate requirements globally • Ability to drive continuous improvement strategy and operational improvement opportunities • Fluency in the English language (written and verbal) is a requirement for this position • Prior coaching experience as a people manager • Proven ability to function autonomously in a matrix model and in a team environment • Experience evaluating and understanding quality standards or their application • Ability to identify risks, propose effective mitigations and escalate as needed • Has proven leadership capabilities and can represent Pfizer in industry conferences and with stakeholders • Able to engage correct path for stakeholder engagement • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. Bonus Points If You Have (Preferred Requirements): • Master’s or advanced degree preferred • Auditor certification to a recognized professional body preferred. • Membership in at least one relevant professional body, ideally with a formal continuous professional development requirement • Strategic leadership of GMP Quality or Audit teams (specialized and large teams) • Experience representing organization or company externally • Demonstrated experience managing budgets • Experience contributing to business strategy/projects • Proven ability to coach/mentor colleagues and to grow and develop talent • Experience managing performance of group and holding team accountable for internal KPIs • Prior experience in organizations or with applications for continuous improvement or metrics trending highly desirable Non-Standard Work Schedule, Travel or Environment Requirements 20% travel Work Location Assignment: Remote - Field Based The annual base salary for this position ranges from $169,700.00 to $282,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States. Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. Pfizer endeavors to makewww.pfizer.com/careersaccessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please emaildisabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Legal Affairs