QA Compliance Lead - Afternoons

About the role

The QA Compliance Lead is the senior-most QA Compliance resource supporting manufacturing operations and serves as the primary day-to-day quality lead. This role ensures consistent execution of cGMP compliance activities, including batch record review, deviation investigations, CAPA oversight, and audit readiness. The Lead acts as a key partner to the QA Manager by driving quality processes, supporting regulatory readiness, and providing guidance to QA Compliance Associates.

Responsibilities

• Own day-to-day QA compliance activities across manufacturing, ensuring timely batch review and product release in accordance with GMP standards.
• QA oversight of manufacturing, including label control and issuance and in-process inspections.
• Lead deviation investigations, OOS events, and non-conformances, including root cause analysis and CAPA development.
• Review and approve QA documentation (batch records, deviations, CAPAs) prior to QA Manager escalation where required.
• Serve as primary QA contact on the floor, providing real-time guidance to Associates, operators, and supervisors.
• Cover conduct and support internal audits to ensure adherence to SOPs, cGMP, and regulatory requirements.
• Support regulatory inspections and customer audits, including preparation, hosting support, and follow-up actions.
• Monitor QA systems and quality trends, escalating risks and recommending improvements.
• Support SOP and document updates to maintain compliance and operational efficiency.
• Coach and mentor QA Compliance Associates on investigations, documentation, and GMP expectations.
• Partner cross-functionally with Operations, QC, and other teams to drive a culture of quality and compliance.

Qualifications & Experience

• 5–7 years in pharmaceutical QA / GMP environment
• Strong experience in: Batch record review & product release
• Deviation investigations & CAPA systems
• Audit support (FDA/customer)
• Demonstrated ability to work independently and make quality-based decisions
• Strong technical writing and documentation skills
• Prominent ability to coach others without formal authority

What We Offer

• Health Insurance (medical, dental, vision)
• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals. Bimeda’s global innovation program sees eight state-of-the-art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry. Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids. Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

Equal Opportunity Employer

Bimeda is an equal opportunity employer committed to fostering a diverse workforce. All qualified applicants will be considered without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.