Manager, QA

Work ScheduleFirst Shift (Days)Environmental ConditionsOfficeJob DescriptionAt Thermo Fisher Scientific, we provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions, like protecting the environment, making sure our food is safe or helping find cures for cancer.Excellent Benefits PackageReview our company’s Total Rewards (https://jobs.thermofisher.com/global/en/total-rewards)Medical, Dental, & Vision benefits-effective Day 1Paid Time Off & Holidays401K Company Match up to 6%Tuition Reimbursement – eligible after 90 days!Employee Referral BonusEmployee Discount ProgramRecognition ProgramCharitable Gift MatchingCompany Paid Parental LeaveCareer Advancement OpportunitiesLocation:High Point, NCView site products and services here: Softgel Manufacturing in High Point, NC - YouTube (https://www.youtube.com/watch?v=B1kzDFF39XU)As a QA Manager, you will play a crucial role in ensuring the highest quality standards are met in our Pharma Services Group (PSG) located in High Point, NC. 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.The Quality Assurance Manager leads and owns site audits, document control and training programs. Conducts internal audits, supplier quality management activities, hosts customer audits and regulatory inspections.A Day in the Life:

Interprets FDA regulations and comparable international regulations, SOPs, and other company policies and procedures on adherence to regulatory compliance.

Maintains an effective understanding of current regulatory industry requirements.

Conducts and directs external audits of suppliers, vendors, contract manufacturers, contract laboratories, and contract service providers to identify deficiencies and non-conformances, assess and report the level of compliance to regulatory and quality requirements.

Responsible for proactively reporting training metrics, and for facilitating cGMP-related learning and development programs, including a training plan for the site.

Manages and coordinates the activities of the document control and training personnel consisting of approximately 4-7 people.

Education and Experience:

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.

Idealy, have experience with manufacturing oral solid dosage pharmaceuticals or dietary supplements.

A Certified Quality Auditor (CQA) is preferred

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does 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.