Supervisor, Quality Assurance

OUR TEAM: Promega's Product Quality & Compliance (PQ&C) team is building out dedicated leadership capacity to keep pace with the company's growth. This Supervisor role is being created specifically to support the quality professionals who keep Promega's quality functions running day to day: new product setup, external notifications, quality survey responses, label approvals, ADP assignments, product quarantine management and routine product release. Rather than splitting supervisory attention across scientific and operational priorities, this role lets one leader focus on the team supporting operational needs and on continuously improving the systems they run.

YOUR ROLE: As Supervisor, Quality Assurance, you'll lead the team that keeps Promega's quality systems running day to day - new product setup, external notifications, quality survey responses, label approvals, and routine product release - and own the disposition and release calls that come with that work: nonconforming product, quality holds, and general disposition planning.

Quality system tools and documentation increasingly run through AI-supported platforms that can track dispositions, route notifications, and flag where a process is falling behind. They cannot decide whether a nonconforming product is safe to release, whether an employee needs more coaching or more autonomy, or which process fix is worth the disruption to implement. That judgment is yours - AI is a tool you and your team use, not a check on your work.

JOB OBJECTIVE: The Supervisor, Quality Assurance leads and develops Promega's quality systems and operations team, owning disposition and release decisions, daily oversight of QA-owned processes, and continuous improvement of the quality systems the team runs.

CORE DUTIES:

1. Leads and develops the systems and operations team, supervising Quality Specialists/Senior Specialists who own new product setup, external notifications, quality survey responses, label approvals, product quarantine management, and ADP assignments.

2. Takes part in disposition and release decisions: contributes to and coaches team on making calls on nonconforming product, quality holds, and general disposition planning, and owns the routine product release process.

3. Provides daily oversight of QA-owned processes, including batch record review, deviations, investigations, and the product stability program.

4. Uses KPIs to identify where quality system processes are creating rework or delay, and builds the case for the resources to fix them.

5. Reviews and approves the records tied to these processes so they hold up to procedural and regulatory scrutiny.

6. Represents QA on cross-functional operational teams and with external customers and suppliers on systems and disposition topics.

7. Recruits, coaches, and develops staff, including setting performance expectations and career development plans.

8. Works with the QA Leadership Team to develop departmental staffing, budget, training, and capital expense plans annually or as needed to meet departmental and business needs.

9. Organizes, facilitates, or leads cross-departmental teams, and presents project and program updates or training to leadership and company employees as required.

10. Participates in training programs in areas of expertise and experience.

KEY QUALIFICATIONS:

1. B.S. or M.S. plus 8 years of experience, or Ph.D. plus 5 years of experience, in molecular biology, cell biology, proteomics, chemistry, or a Quality Assurance-related field.

2. Demonstrated technical understanding of development, manufacturing, and quality assurance processes for life science research products.

3. Experience achieving results in a cross-functional environment.

4. Strong verbal and written communication skills.

5. Independent self-starter with proven planning, leadership, and project management skills.

6. Comfortable using AI-supported tools day to day for documentation, tracking, and routing across the processes the team owns, and willing to help the team build that same fluency.

PREFERRED QUALIFICATIONS:

1. Experience recruiting, coaching, and developing staff.

2. Experience in a professional QA organization.

3. Working knowledge of ISO 13485, US FDA 21 CFR 820, EU IVDR, MDSAP, and QSMR quality system requirements.

4. Direct experience in an ISO, cGMP, FDA, or other regulated environment.

5. Experience in quality work related to in vitro diagnostic medical devices.

6. Working knowledge of ICH Q7 and other API regulatory requirements.

PHYSICAL DEMANDS:

1. Ability to work with computers.

2. Ability to lift 20 lbs.

3. Ability to work occasionally in a laboratory environment.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.