Sr Manager, Operations
Sr Manager, Operations
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 65000 extraordinary minds has a unique story to tell. Join us and contribute to our unusual missionempowering 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:
- Bachelors 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.
Required Experience:
Manager
Employment Type
Full-Time
