YOUR ROLE: As Supervisor, Quality Assurance, you'll lead the QA team that partners with New Product Development, owning the technical judgment calls that keep new and existing products moving - shelf-life and stability decisions, batch release disposition, and change control. You'll be the primary technical authority your team turns to on tough calls, and the technical quality voice that cross-functional partners and customers rely on when questions get hard.

Promega's quality function increasingly uses AI-supported tools for tracking, documentation, and information routing. Those tools can organize a study or surface a data trend; they cannot decide whether a shelf-life claim holds up, whether a product is ready to launch, or how to coach a scientist through a tough investigation. That judgment, and the coaching relationships behind it, are 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 NPD-facing QA team, owning shelf-life and stability decisions, batch release disposition, and change control review, and serving as the technical quality authority for cross-functional partners, customers, and suppliers on product-quality questions.

CORE DUTIES:

1. Leads and develops the NPD-facing QA team, supervises QA Scientists who partner with New Product Development to confirm new products meet their design and performance requirements before launch.

2. Owns shelf-life and stability decisions: supervises staff who review study designs, evaluate data, and approve process changes for shelf-life assignments in partnership with Manufacturing, Marketing, and R&D.

3. Owns batch release and change control: supervises staff who disposition batch release decisions and drive change control review, working closely with Operations to keep product moving through inventory.

4. Serves as the technical quality voice, directing the team's role in verifying product claims and resolving technical questions from customers and cross-functional partners.

5. Uses KPIs to identify where the NPD-facing and product support QA functions need more resources or a different process, and makes the case for it.

6. Reviews and approves batch records, work instructions, labels, and product literature tied to new and existing catalog and custom products.

7. Represents QA on new product development teams and with external customers and suppliers when product-quality expertise is needed.

8. Recruits, coaches, and develops QA Scientist staff, including setting performance expectations and career development plans.

9. 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.

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

11. 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 literature and data synthesis, documentation support, and information routing, 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.