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Thermo Fisher Scientific

Thermo Fisher Scientific

via Phenompeople

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Principal Operational Process and Compliance Specialist

Anywhere
full-time
Posted 9/30/2025
Direct Apply
Key Skills:
Process Improvement
Risk Assessment
Quality Management
Compliance Practices
Data Analysis
Collaboration
Mentoring
Negotiation
Clinical Research
Attention to Detail
Regulatory Guidelines
Creative Thinking
Critical Thinking
Decision Making
Teamwork
Communication

Compensation

Salary Range

$Not specified

Responsibilities

Manages complex process improvement initiatives to enhance compliance and efficiency. Collaborates with senior leadership to align process improvements with business priorities.

Requirements

A bachelor's degree or equivalent is required, along with 8+ years of relevant experience. Significant clinical research experience across all phases of the clinical study life cycle is preferred.

Full Description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on – now and in the future. Summarized Purpose: Manages complex process improvement initiatives, working cross-functionally to enhance compliance, efficiency, and risk mitigation. Serves as a key resource in quality system governance. Essential Functions: • Leads mid-to-large scale, complex process improvement projects across departments. • Proactively conducts in-depth risk assessments and develops mitigation strategies for quality concerns. • Establishes and maintains process governance frameworks to ensure consistency in quality and compliance practices. • Analyzes trends and provides insights for process optimization and compliance improvement. • Collaborates with senior leadership to align process improvements with business priorities. • May act as a subject matter expert in an assigned area. • Mentors less experienced team members providing guidance on best practices in quality and process management. Job Complexity: Works on complex issues where analysis of situations or data requires an indepth evaluation of variable factors. Job Knowledge: Having wide-ranging experience, uses professional concepts and company objectives to resolve complex issues in creative and effective ways. Some barriers to entry exist at this level (e.g., dept. / peer review). Level at which career may plateau. Supervision Received: Determines methods and procedures on new assignments and may coordinate activities of other personnel (i.e., Team Lead). Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results. Business Relationships: Frequent contacts with internal personnel and outside customer representatives at various management levels concerning operations or scheduling of specific phases of projects or contracts. Creates formal networks with key contacts outside own area of expertise. Qualifications: Education and Experience: • Bachelor's degree or equivalent and relevant formal academic / vocational qualification • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). • Significant clinical research experience in all phases of clinical study life cycle, including start-up, interim and close-out, is preferred. Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions. Knowledge, Skills and Abilities: • Broad understanding of procedural documents • Excellent understanding of process improvement practices • Advanced investigative and analytical skills • Strong negotiation skills • Broad understanding of clinical management technology and systems, and strong computer skills • Familiarity with the practices, processes, and requirements of clinical trials • Strong judgment, decision making, escalation, and risk management skills • Effective oral and written communication skills including the ability to communicate in English, both orally and in writing • Capable of directing and promoting teamwork in a multi-disciplinary and/or multi-cultural team setting • Great attention to detail • Broad understanding of regulatory guidelines and directives • Excellent creative and critical thinking skills Management Role: No management responsibility. Working Conditions and Environment: • Exposure to high pressure, intense concentration needed • Must pay constant attention to detail-visual, mental • Must be able to multi-task constantly • Frequent interaction with clients / associates required • Long, varied hours required occasionally • Travel and rotating shifts required on occasion • Exposure to toxic materials on rare occasions Physical Requirements: • Frequently stationary for 6-8 hours per day. • Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. • Frequent mobility required. • Occasional crouching, stooping, bending and twisting of upper body and neck. • Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs. • Ability to access and use a variety of computer software developed both in-house and off-theshelf. • Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. • Frequently interacts with others to obtain or relate information to diverse groups. • Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration. • Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. • Regular and consistent attendance. Salary Transparency: This is a salaried role that will also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. Compensation will be initially discussed during the screening period, with actual compensation confirmed in writing at the time of offer. We offer a comprehensive Total Rewards package that our US colleagues and their families can count on, which generally include: • A choice of national medical and dental plans, and a national vision plan • A wellness program, and valuable health incentive opportunities for company contributions to a Health Reimbursement Accounts (HSAs) or Health Savings Account (HSA) •Tax-advantaged savings and spending accounts and commuter benefits • Employee assistance programs • At least 120 hours paid time off (PTO). 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, short- and long-term disability, and volunteer rime off in accordance with company policy. • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan Accessibility/Disability Access: We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. EEO & Affirmative Action: Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

This job posting was last updated on 10/1/2025

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