Quality Systems QA Manager

Scientific Protein Laboratories LLC; United States; On-site; USD 90,000 - 140,000; Full time

Benefits offered by this job

Competitive compensation

Benefits on Day 1

Life and AD&D Insurance

Short and Long-term Disability

Health Savings Account

Employee Assistance Program

401k

Advancement opportunities

Team oriented environment

Community involvement

Company events

Job summary

Scientific Protein Laboratories LLC in Wisconsin (Waunakee, near Madison) seeks a QA Supervisor to lead the site's Quality Systems, investigations, CAPAs and change controls. You’ll manage cGMP training, product release activities, and customer-facing quality agreements with a focus on compliant documentation and audits.

The role requires extensive experience in quality systems, inspections readiness, and cross-functional collaboration, with responsibilities for metrics and annual product

Qualifications

• Education in natural sciences is preferred for the role.

Responsibilities

• Manage Quality System functions and training oversight.
• Coordinate investigations, deviations, CAPAs and change controls.
• Approve deviations and related CAPAs, and validate documents.
• Oversee procedures and document maintenance.
• Communicate quality metrics to management as required.
• Prepare Annual Product Review documentation for SPL products.
• Draft customer-related Quality Agreements and ensure compliance.

Education

Associate's Degree

Bachelor's Degree in natural sciences

Job description

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

Position Summary

Responsible for management of the sites 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.
• Oversee the establishment/maintenance of relevant procedures/documents
• Compiles and communicates metrics associated with the Quality System to management as required.
• Responsible for the prompt, technically accurate and cGMP-compliant preparation of Annual Product Review documentation for all SPL Marketed Products.
• Writes customer-related Quality Agreements and verifies SPL is compliant with the approved Quality Agreements (including customer notifications)
• 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.
• Participates in the Material Review Board including assessment of customer complaints. Participates in assigning and addressing all customer communications.

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
• Experience with professional, transparent compliance engagement with external authorities
• Demonstrate experience in inspection, inspection readiness, coordination, and proper documentation. Coaching team experts to speak on documents as needed.
• Experience in relationships with managing consultants
• Experience managing metrics reporting for technical aspects, navigating change control
• Experience managing the needs for annual product reviews, vendor audits
• Experience escalating issues to solve problems
• Coach sales to understand compliance

WHY JOIN SPL?

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

• 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.