Senior Quality Assurance Manager

ABOUT PARNELL

Parnell Veterinary Pharmaceuticals is a global animal health company with a manufacturing facility in Menominee, WI, and a corporate office in Kansas City, serving as a hub for commercial operations, sales, marketing, digital technology, and corporate services, alongside our headquarters and manufacturing facility in Alexandria, Sydney, Australia.

We support veterinarians, producers, and pet parents with differentiated solutions designed to improve animal health outcomes.

We offer personal and professional development opportunities for individuals who embody our core values of Professionalism, Excellence, Teamwork, Safety, and Sterility, within an exciting, fast-paced, and entrepreneurial environment.

Are you ready to step into a key role at a dynamic, purpose-driven company? We’re looking for a proactive, detail-oriented Senior Quality Assurance Manager to join our team in our manufacturing facility in Menominee, WI and help power our mission to deliver excellence - every time.

The Senior Quality Assurance Manager, WI site, will be responsible and accountable for directing the Quality Assurance activities and supporting Quality Control as required, to ensure that facility is maintained in a state of validation, and drug products are manufactured & tested in compliance with cGMP requirements and regulations. The individual will ensure proper execution and administration of the GXP Quality System pertaining to GMP and GLP.

The individual will be responsible, working with other site functions, for strengthening Quality Systems and processes across all company departments. The Quality Manager will oversee document control, batch release, In-Process Quality Assurance, complaints and compliance, including SOPs, Validation/Qualification documentation, Deviations and Non-Conformances, and change control.

By monitoring all critical quality events, the individual will proactively identify quality issues, concerns or any potential or significant risks to the business and ensure that appropriate preventative actions are put in place. This may include escalation to the VP of Quality and Senior Management, placing product on hold and/or ceasing production activities for any issue that is considered critical for the company and cGMP compliance including (but not limited to) matters related to animal safety and regulatory compliance.

The Senior Quality Assurance Manager will hire, coach and develop both direct and, as appropriate, indirect reports through ongoing, example-based performance feedback, annual performance reviews and the provision of training and development opportunities. The individual will also ensure that performance issues are managed in a consistent and timely manner. Ensure that all quality personnel have the competency, knowledge and skills to perform their roles.

This position regularly interacts with other key functions, senior leadership, regulatory agencies, and external clients.

• Contribute to the development and maintenance of cGMP compliance applicable to all relevant regulatory jurisdictions.
• Manage the site’s document control system, including Master Batch Records, Standard Operating Procedures, Component Specifications, Calibration Records and other documents.
• Build and strengthen all required processes and controls necessary for manufacture, testing, and release of pharmaceutical products in an FDA-regulated facility
• Assure that all manufacturing processes, analysis, and relevant activities are in conformance with cGMP and regulatory filings
• As required, provide technical and analytical support to the Quality Control function, including microbiology labs.
• Assure that the GMP-related documentation is in conformance with site procedures
• Ensure a documented system and procedure is in place to enable effective and efficient notification of Product recalls, plus effective retrieval of affected product.
• Review and approve validation Master Plans, Validation Protocols, and Validation reports as required
• Coordinate Site Quality Management Reviews.
• Develop audit plans and conduct internal and external audits to…