Associate Manager, Quality Assurance (GMP)
About the position This is a hybrid role based at our GMP Laboratory in Middleton, WI. The onsite expectations for this role are ~3 days per week. We welcome applicants from all locations within the US. Please note that relocation assistance is not provided for this position, and any relocation costs will be the responsibility of the candidate. Must be legally authorized to work in the United States. Must be able to pass a comprehensive background check, which includes a drug screening. 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. Our PPD® Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our laboratory professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations. Discover Impactful Work: The Associate QA Manager provides frontline leadership for junior QA Auditors and supports continuity of operations through resourcing, training, issue escalation, and staff development. This role oversees the quality of data and reports generated by GMP laboratory support functions, including equipment and software validation (IQ/OQ/PQ) documentation, instrument maintenance and calibration records, and facility qualification documentation. The Associate QA Manager also performs hands-on operational work within Support QA, Records Management, and other assigned areas as needed to maintain business continuity, support priority workflows, resolve escalations, and model expected standards for staff.
Responsibilities
- Manage the day-to-day operations of a QA team and provide oversight, development and performance management to staff to meet performance objectives
- Assess with supervisors priority of projects and monitor work assignments ensuring adequate resourcing to meet internal and client timelines and provide quality deliverables
- Assist senior management in the evaluation of QA programs to help maintain regulatory compliance and efficiency of QA audits
- Evaluate issues and trends reported by QA staff and determine appropriate departmental interpretation. Identify issues that may require follow-up or improvement. Communicate findings to staff and senior management
- Participate in client and regulatory inspections in order to provide information regarding the QA program and facilitate responses
Requirements
- 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 5+ years).
- 1+ year of leadership responsibility
- Solid leadership and time management skills
- Knowledge of appropriate regional regulations and applicable global pharmaceutical industry guidelines
- For Lab QA Management, knowledge of analytical methodologies, instrumentation and method validation required
- Good verbal and written communication skills
- Demonstrated proficiency with regulations and guideline interpretation, proper documentation and QA departmental policies and procedures
- Detail oriented with ability to deal with multiple and changing priorities
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