CDMO QA Supervisor

JOB SUMMARY

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 as a CDMO QA Supervisor

This position is responsible for developing, implementing and maintaining the Quality System to support the integrity and compliance of all data generated from process development, engineering batch production, clinical trials, etc. for registration filings before product process validation and related document review. This position is also responsible for developing and implementation of a program and related processes for responding to customer inquiries about quality related technical or regulatory compliance for all SPL products and services. The supervisor is responsible for personnel activities such as: reviews, workload management and coordination of training.

Responsibilities include:

• Release raw materials, products (process development batches, engineering batches, clinical trial batches) and GLP test activities to support the CDMO business.

• Organize the establishment/maintenance of relevant procedures/documents

• Support specification development for CDMO projects.

• In collaboration with customers and the CDMO/Regulatory Affairs departments, assist with the preparation of regulatory dossiers supporting CDMO projects.

• Provide direction and advice on the application of quality requirements to CDMO projects.

• Writes CDMO project related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications) supporting CDMO projects where necessary.

• Responsible for tracking and coordinating responses to all customer communications/inquiries.

• Responsible for continuous improvement of SPL cGMP Quality Systems to support CDMO projects in compliance with FDA, ICH, USDA, ISPE and other pertinent pharma industry requirements.

• Compiles and communicates metrics associated with CDMO projects to management as required.

• Participates in audits and addresses audit findings where necessary.

• Performs CDMO product release and shipping documentation review/approval.

Job Requirements and Qualifications:

• Education: Required: Bachelor’s Degree, Preferred: Graduate Degree

• Experience: Required: 5+years Material release, product development and validation, test method development and validation, approval of investigations, quality agreement and change controls. Preferred: 10+ years, All of the above plus biologics, drug substances and DMF’s.

WHY JOIN SPL?

Our employees are our success! We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.