Senior Quality Assurance Manager

Parnell is on an exciting growth trajectory, and we are seeking an experienced Senior Quality Assurance professional to join our Leadership Team at our Menomonie, Wisconsin manufacturing facility.

The Menomonie facility is embarking on a significant expansion program, including the development and implementation of new sterile manufacturing capabilities and the introduction of two new products over the next three years. This investment forms an important part of Parnell’s broader strategy to expand its global manufacturing capabilities and support future growth.

This is an opportunity to join Parnell at a pivotal stage of its global manufacturing expansion. In addition to supporting the continued development and performance of the Menomonie operation, the role will play an important part in establishing and scaling Parnell's second manufacturing facility in the Wisconsin/Milwaukee area.

The successful candidate will contribute to building the Quality systems, processes and culture required to support both current operations and future manufacturing capability. This includes partnering closely with Manufacturing, Engineering, Technical Transfer, Supply Chain and other global functions to ensure that new products, processes, equipment and facilities are introduced in a compliant, robust and scalable manner.

The role will be instrumental in helping Parnell build a consistent global Quality culture and operating model, while ensuring that both Wisconsin facilities meet applicable cGMP and regulatory requirements and are positioned to support Parnell's long-term growth.

Reporting directly to the Vice President of Global Quality, based in Australia, this role offers the opportunity to influence the development of Quality Assurance within a growing global pharmaceutical manufacturing organisation as a participant on the Parnell Quality Leadership (QLT) team and be part of the establishment of a new manufacturing facility from the ground up.

• 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
• 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
• Develop audit plans and conduct internal and external audits to ensure vendors are appropriately qualified.
• 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
• 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

You're a proactive, solutions-focused and enthusiastic who takes pride in your work and thrives in a fast-paced, regulated environment. You bring:

• Strong interpersonal, problem solving,…