Quality Systems QA Manager

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee! SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally. For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs). SPL has an exciting opportunity to join the team.

Position Summary

Responsible for management of the site’s Quality Systems including but not limited to cGMP training, investigations (including customer complaints), deviations, change controls and CAPAs. Develops and maintains cGMP-compliant Quality Management Systems. Responsible for management of SPL's quality compliance throughout SPL which includes operational activities such as: release of intermediate and finished product, review/coordination of investigations (including customer complaints), approval of deviations, change controls, and CAPAs; approval of validation/qualification documents; hosting of external agencies and/or customer audits. The manager is responsible for personnel activities such as: reviews, workload management and coordination of training.

Responsibilities Include:

• Responsible for the functions associated with the Quality System, including oversight and coordination of training, investigations (including customer complaints), deviations, change controls, CAPAs and validation/qualification documents.

• Participates in the Material Review Board including assessment of customer complaints. Participates in assigning and addressing all customer communications.

• Oversee the investigation of process deviations, product failures, customer complaints or facility incidents and assure proper documentation and investigation per established procedures. Approves minor deviations and related CAPAs.

• Writes customer-related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications)

• Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products.

• Compiles and communicates metrics associated with the Quality System to management as required.

• Oversee the establishment/maintenance of relevant procedures/documents

Requirements:Education:

• Associate's Degree, Bachelor's Degree in natural sciences or above preferred

Experience:

• 10+ years of experience, 15+ years preferred

• History of developing Quality Systems’ teams’ skills with examples of coaching to goals, identifying strengths, mentoring, encouraging cross-functional collaboration