Manufacturing Quality Assurance Program Manager

Location: Seven Lakes Pharmacy, Shoreview MN

Hours: 80 hours bi-weekly

Schedule: days

The Manufacturing Quality Assurance Manager leads and directs all aspects of the Quality Assurance Program for a 503B outsourcing facility that performs aseptic manufacturing, repackaging and distribution. The Manager leads the Quality Assurance team, and acts as the Quality representative for regulatory authorities and 3rd party auditors for drug product production. The Manager works in partnership with operations leadership to assure quality of drug products comply with applicable regulations and specifications. The Manager will frequently support new initiatives, including new drug product, component or container closure system, and support quality validation efforts.

Responsibilities

• Ensure pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations and specifications.
• Manage, through subordinates, the coordination of activities of all Quality functions within the 503B outsourcing facility organization including Batch Release, Label Control, the Deviation, CAPA and Change Control quality systems, Validation Studies and Processes, Internal Auditing, and Document Control.
• Provide expertise and guidance in interpreting governmental regulations, agency guidance's and internal policies.
• Use technical skills and tools to create reports that identify and summarize monitoring and audit findings, as well as CAPA plans, to share with pharmacy operations and audit stakeholders.
• Create the annual product review and quality systems report used in developing quality initiatives for the 503B outsourcing facility.
• Conduct staff compliance and quality training as necessary based upon monitoring, surveillance and audit findings. Ensures proper documentation of all training.
• Manage product complaints for pharmaceutical compounded products and ensure that appropriate investigations are conducted. Co-manage recalls with operations management.
• Manage all regulatory inspections and third-party audits, as needed.
• Lead and motivate team members while supporting organizational change to improve processes and achieve team goals.
• Plan, prioritize, and manage multiple projects and workflows, ensuring accuracy, organization, and timely completion of tasks.

Required Qualifications

• Bachelor of Science Biological Science, Chemistry, Engineering or a related field
• 4 years experience in Quality or related field in the pharmaceutical, laboratory or medical device industry.
• 2 years managerial experience directly managing people and/or leadership experience leading teams, projects, programs
• Excellent interpersonal, communication, influencing, and negotiation skills.
• Strong computer skills, database management, and documentation preparation (Word, Excel, PowerPoint)

Preferred Qualifications

• Advanced degree in Biological Science, Chemistry, Engineering or a related field
• Strong understanding of 21 CFR Part 210/211 requirements and knowledge of tools, concepts and methodologies of quality assurance and compliance systems, e.g. FDA
• Experience within a 503B outsourcing facility and/or aseptic/parenteral manufacturing environment
• ASQ Certification in Quality Improvement Associate, or similar
• ISO 9001 (or ISO 17025) Internal Auditor Certification

Fairview offers a generous benefit package including but not limited to medical, dental, vision plans, life insurance, short-term and long-term disability insurance, PTO and Sick and Safe Time, tuition reimbursement, retirement, early access to earned wages, and more! Please follow this link for additional information: https://www.fairview.org/careers/benefits/noncontract

The posted pay range is for a 40-hour workweek (1.0 FTE). The actual rate of pay offered within this range may depend on several factors, such as FTE, skills, knowledge, relevant education, experience, and market conditions. Additionally, our organization values pay equity and considers the internal equity of our team when making any offer. Hiring at the maximum of the range is not typical. If your role is eligible for a sign-on bonus, the bonus program that is approved and in place at the time of offer, is what will be honored.

Salary : $102,149 - $144,227