Senior Project Manager, Quality

This is a fully remote position, open to applicants in District of Columbia.

📋 Description

• Act as the leader for quality execution in strategic manufacturing, validation, and infrastructure initiatives.

• Spearhead the implementation of quality-related tasks necessary to propel complex projects forward, including change controls, risk assessments, validation readiness, customer change notifications, quality approvals, and compliance efforts.

• Provide guidance across various functions to ensure that quality standards are embedded in project execution while adhering to compliance, safeguarding supply continuity, and fostering business expansion.

• Directly impact the successful execution of large-scale manufacturing projects, product transfers, facility enhancements, and new business ventures while upholding Thermo Fisher Scientific's dedication to delivering high-quality, compliant products to our customers.

⛳️ Requirements

• An advanced degree with 6 years of experience, or a bachelor's degree with 8 years of experience in Quality, Validation, Engineering, Manufacturing, Regulatory Affairs, Project Management, or related fields within a regulated industry.

• Preferred areas of study include Engineering, Chemistry, Biology, Pharmacy, Life Sciences, Quality Systems, or a related scientific/technical discipline.

• PMP certification, ASQ Certified Quality Engineer (CQE), Certified Quality Auditor (CQA), or equivalent certification is preferred.

• Over 5 years of experience leading cross-functional projects, programs, or quality initiatives in a regulated manufacturing setting.

• Proven experience in managing change controls, risk assessments, deviations, investigations, and quality system processes.

• Strong knowledge of Quality Management Systems and relevant regulations (FDA, ISO 13485, ISO 9001, cGMP).

• Experience in supporting validation activities, including the review and approval of User Requirements Specifications (URS), risk assessments, validation protocols, validation summary reports, and technical documentation.

• Demonstrated ability to evaluate the quality impact related to equipment modifications, process changes, product transfers, facility upgrades, and manufacturing enhancements.

• Experience in leading change control activities and facilitating cross-functional impact assessments.

• Excellent technical writing skills, including the creation of customer change notifications, quality memos, risk assessments, technical justifications, and regulatory documentation.

• Experience acting as a customer-facing quality representative and effectively conveying quality-related changes, risks, and presenting project updates.

• Ability to forge strong working relationships across Quality Assurance, Quality Engineering, Quality Control, Engineering, Validation, Manufacturing, Regulatory Affairs, Supply Chain, and Site Leadership.

• Experience in identifying, escalating, and resolving quality, compliance, and execution risks affecting project delivery.

• Proven ability to influence decision-making and foster accountability without direct authority.

• Strong analytical, problem-solving, and risk-based decision-making skills.

• Experience collaborating with Documentation Control and Training teams to ensure the timely implementation of SOPs, controlled documents, training curricula, and quality system requirements.

• Proficiency in electronic Quality Management Systems, MasterControl, TrackWise, SAP, Document Management Systems, and Microsoft Office applications.

• Experience in supporting audit readiness, inspection preparedness, and proactive quality gap identification and remediation efforts.

• Lean Six Sigma, continuous improvement, or operational excellence experience is preferred.

• Strong written and verbal communication skills, capable of effectively communicating at all organizational levels, including customers, site leadership, and executive stakeholders.

• Ability to manage multiple priorities and achieve quality-related project milestones in a fast-paced, highly regulated environment.

• Willingness to travel up to 20% as required.

🏝️ Benefits

• A selection of national medical and dental plans, along with a national vision plan that includes health incentive programs.

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement.

• At least 120 hours of paid time off (PTO), 10 paid holidays each year, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability according to company policy.

• Retirement and savings options, such as our competitive 401(k) U.S. retirement savings plan.

• Employees' Stock Purchase Plan (ESPP) provides eligible colleagues the opportunity to purchase company stock at a discounted rate.