Quality Systems and Compliance Manager
Padagis LLC•Golden Valley, MN
•$85,000 - $120,000•Onsite
About The Position
Padagis is hiring a Quality Assurance (QA) Compliance Manager to ensure the quality and compliance of operational activities occurring at the facility by overseeing validation, internal audit, external audit management and response, data review, product complaints, product lifecycle, change management, investigations, CAPA and continuous improvement. The person selected for this position will lead a team of 5 QA professionals.
Requirements
- Bachelor’s Degree in engineering, a science discipline, or closely aligned field.
- 5+ years experience in a cGMP manufacturing environment.
- Experience managing, responding to, and following-up on internal and external (like FDA) audits.
- Demonstrated experience applying cGMP’s and US FDA laws and requirements in an FDA regulated industry.
- Excellent oral and written communication and interpersonal skills.
- Demonstrated computer literacy, including Microsoft Excel and Word.
- Strong attention to detail and ability to follow written procedures.
- Demonstrated ability to make quality decisions in stressful situations.
- Knowledge and experience in validation concepts (process, method, computer and cleaning), equipment qualification, change management, product lifecycle, master record approval, internal auditing, data review, risk mitigation, investigations and CAPA planning.
Nice To Haves
- Pharmaceutical industry experience.
- Experience in QA and/or quality management systems (QMS).
Responsibilities
- Provides oversight to and support of site activities related to quality, including internal and external audit preparation and response activities (50%)
- Participates in quality events and closes unplanned deviation events (20%)
- Conducts training for direct reports and takes part in needed training to perform job function (10%)
- Participates in Continuous Improvement initiatives (10)%
- Provides performance-based feedback to direct reports, including completion of annual performance reviews (5%)
- Seeks assistance on Human Resource issues (5%)
Benefits
- two annual cash incentive bonus plans
- a robust and affordable employee benefits program
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What This Job Offers
Job Type
Full-time
Career Level
Manager
