Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our unusual mission—empowering our customers to make the world healthier, cleaner and safer. Your work will make a difference, helping our customers find cures, protect the environment, and ensure food safety. We support your career goals.

Job Title: Sr Manager, Manufacturing Compliance

Reports to: Vice President / General Manager

Group / Division: Biologics or equivalent experience

Career Band: 8

Position Location: St. Louis, MO

Number of Direct Reports: 4

Position Summary:

Are you ready to lead a team of passionate Manufacturing Compliance Engineers? We are looking for a dedicated leader who can inspire and lead a team, potentially including subordinate Managers/Supervisors. This role is vital in maintaining the highest levels of compliance and manufacturing excellence for the St. Louis site. By applying ALCOA+ principles, you will ensure inspection readiness, champion a culture of quality, and uphold GMP and regulatory standards.

Key Responsibilities:

In this role, you will:

• Ensure Inspection Readiness: Maintain readiness for regulatory and customer audits. Collaborate with Quality and Regulatory teams to coordinate and support mock audits and readiness assessments. Serve as the main point of contact for Operations during inspections, ensuring accurate and timely responses to auditor queries.
• Oversee Quality Systems: Ensure timely execution of GMP documentation, including SOPs, batch records, and other controlled documents. Coordinate deviation management, CAPA execution, and change control processes for Operations.
• Promote Training & Compliance Culture: Support the Training department in developing and implementing training programs, including online, classroom, and on-the-job training. Conduct regular compliance briefings and workshops for operational teams.
• Supervise Processes & Compliance Metrics: Develop and monitor key compliance metrics such as Right First Time (RFT), On Time Delivery (OTD), Corrective and Preventative Actions (CAPA), and audit findings closure rate. Generate periodic compliance reports and present findings to Operations and Site Leadership.
• Manage Risks: Conduct/support risk assessments for processes and systems to identify potential compliance gaps. Collaborate with cross-functional teams to implement risk mitigation strategies.
• Investigate Deviations: Lead or support investigations into deviations, non-conformances, and other quality issues/incidents. Ensure timely and detailed root cause analysis and CAPA planning, execution, and implementation.
• Drive Continuous Improvement: Identify trends from deviations, CAPAs, and internal/external audit findings to drive continuous process and regulatory improvements. Work with Manufacturing and Technical Operations teams to improve quality systems and reduce compliance risks..

Frequent Contacts: You will frequently interact with Department Managers, Supervisors, Technicians, the Site Leadership Team, and Crossfunctional teams (Quality, MS&T, Engineering, etc.). Additionally, you will engage with customers, other Thermo Fisher Scientific Business Units, and Regulatory Agencies (e.g., FDA, EMA, etc.).

Minimum Requirements/Qualifications:

• Bachelor’s degree or equivalent experience, with a minimum of 8 years of biotech industry experience related to manufacturing compliance, quality operations, manufacturing, or a related field. Great! We are looking for someone with this background.
• 3+ years of supervisory experience.

Other Job Requirements:

• In-depth knowledge of GMP, FDA, and other regulatory requirements.
• Successful handling of regulatory inspections and audits.
• Strong leadership and team management skills.
• Excellent problem-solving and critical-thinking abilities.
• Strong communication and social skills.
• Experience with quality systems management, including deviation management, CAPA processes, and change control.
• Develop and deliver effective training programs.
• Strong analytical skills and ability to generate and interpret compliance metrics.
• Work collaboratively with cross-functional teams!
• Proficiency in Trackwise, LIMS, and MS Office applications (Excel, Word, and PowerPoint, etc.)
• Strong attention to detail and ability to implement to standard procedures.
• Drive functional, technical, and operational excellence!
• Ability to encourage and champion innovation, collaboration, and team efficiency.

Why Thermo Fisher Scientific? We offer competitive benefits, including health, dental, and vision insurance, 401(k) with company match, paid time off, and opportunities for professional growth and development. We believe in work-life balance and providing a supportive work environment.

Reasonable Accommodation and Equal Opportunity Employment: Thermo Fisher Scientific is committed to providing reasonable accommodations to individuals with disabilities. We are an EEO/Affirmative Action Employer and do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.