Senior Quality Assurance Manager

The Position

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 the facility is maintained in a state of validation, and drug products are manufactured and 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 preventive 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 matters related to animal safety and regulatory compliance.

The Senior Quality Assurance Manager will hire, coach, and develop direct and indirect reports through ongoing example‑based performance feedback, annual performance reviews and training and development opportunities. The individual will also ensure performance issues are managed consistently and timely, and that all quality personnel possess 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 conform to cGMP and regulatory filings.
• Provide technical and analytical support to the Quality Control function, including microbiology labs.
• Assure that GMP‑related documentation conforms to site procedures.
• Ensure a documented system and procedure for effective notification of product recalls and 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 ensure vendors are qualified.
• Conduct audits of plant activities to determine compliance.
• Create systems and processes for documenting validation activities for methods, cleaning methods, processes, and computerized systems to ensure compliance with applicable regulations.
• Provide support for maintaining training files for employees to ensure regulatory compliance.
• Ensure all quality trends are evaluated, root causes identified, and corrective actions implemented.
• Ensure receipt, control, sampling, inspections, testing, and disposition of all raw materials and components comply with regulatory requirements.
• Oversee investigation of customer complaints, change controls, CAPAs, deviations, and investigations.
• Oversee finished product retention system.
• Establish and maintain an environment that encourages teamwork.
• Strong interpersonal, problem‑solving, and communication…