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.

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.

Summary of the Position:

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.

Essential Duties and Responsibilities:

· 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 ensure vendors are appropriately qualified.

· Conduct audit of plant activities to determine if in compliance

· Create systems and processes for the documentation of validation activities for Methods, Cleaning Methods, Processes and computerized systems such that these systems are compliant to applicable regulations

· Provide support for maintaining training files for employees to ensure compliance with applicable regulations

· Ensure that all quality trends are evaluated, that root causes are identified, and corrective actions are implemented.

· Ensure that the receipt, control, sampling, inspections, testing, and disposition status for all raw materials and associated components upon transfer from distribution or other authority comply with regulatory requirements

· Oversee the investigation of customer complaints, change controls, CAPAs, deviations and investigations

· Oversee the finished product retain system

· Establish and maintain an environment that stresses and encourages teamwork.

Minimum Requirements

· Strong interpersonal, problem solving, and communication (both verbal and written) skills

· Ability to work collaboratively across all internal departments and with external customers.

· Excellent organizational skills with close attention to detail

· Ability to prioritize and manage multiple projects in a fast-paced environment

· Must be proficient in Windows Office Suite (Outlook, Word, Excel, PowerPoint), with advanced Excel skills

Education and Experience:

· A minimum of Bachelor’s Degree in physical/ chemical / life sciences or engineering

· A minimum of ten (10) years of Quality Assurance experience in the pharmaceutical, biotech, or medical devices (Class II or Class III) industries required.

· Working knowledge in FDA 21 CFR Parts 11, 210, 211, USP, ICH quality system requirements, and Quality Risk Management are required.

· Familiarity with the qualification and implementation of 21 CFR Part 11 compliant systems.

· Experience with electronic Quality Management System (eQMS).

The competitive remuneration package includes;

• 41 days PTO each year (22 x Vacation, 10 x Personal, 9 x Public Holidays)
• Quarterly Bonuses
• Annual Bonus
• A top-tier company funded Healthcare program
• 401K, immediately vested with a 4% match

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Referral program
• Vision insurance

Work Location: In person