Quality Assurance Manager
2 weeks ago
At Thermo Fisher Scientific, we are seeking a highly skilled Quality Assurance Manager to join our team in High Point, NC.
About the Role:The Quality Assurance Manager will play a crucial role in ensuring the highest quality standards are met in our Pharma Services Group (PSG). This site specializes in gelatin-based drug delivery dosage forms (softgels) and is committed to developing solutions for some of the world's toughest challenges.
Key Responsibilities:- Interpret and apply FDA regulations and comparable international regulations, SOPs, and other company policies and procedures to ensure regulatory compliance.
- Conduct and direct external audits of suppliers, vendors, contract manufacturers, contract laboratories, and contract service providers to identify deficiencies and non-conformances.
- Manage and coordinate the activities of the document control and training personnel, consisting of approximately 4-7 people.
- Responsible for proactively reporting training metrics and facilitating cGMP-related learning and development programs.
- BA/BS degree in a technical field and 6-8 years of experience in GMP compliance within the pharmaceutical industry, or equivalent combination of education and experience.
- 6+ years of proven experience in a quality leadership position managing direct reports.
- Must have experience hosting client audits and participation in regulatory inspections.
- Must meet applicable DEA security clearance requirements.
Thermo Fisher Scientific offers an excellent benefits package, including medical, dental, and vision benefits, paid time off, holidays, 401K company match, tuition reimbursement, employee referral bonus, employee discount program, recognition program, charitable gift matching, and company-paid parental leave.
We are an equal opportunity employer and welcome applications from diverse candidates.
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