Quality Systems QA Manager

Scientific Protein Laboratories LLC; Waunakee (WI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental & Vision on Day 1

Life and AD&D Insurance

Short & Long-term Disability

Flexible Saving Account options

Job summary

Scientific Protein Laboratories LLC, located near Madison, WI in Waunakee, seeks a seasoned QA Supervisor to lead the site’s Quality Systems. The role manages cGMP training, investigations, deviations, CAPAs, and validation/qualification documents, while coordinating external audits and customer communications.

Responsibilities include producing Annual Product Review documentation, maintaining procedures, and coaching a cross-functional quality team to uphold regulatory compliance and product

Qualifications

• Experience building and maintaining cGMP-compliant Quality Management Systems.
• Ability to coach and develop quality systems teams to goals.
• Strong collaboration with internal functions and external authorities.

Responsibilities

• Manage Quality Systems functions including training, investigations, deviations, change controls, CAPAs and documentation.
• Oversee procedures/documents establishment and maintenance; communicate metrics to management.
• Prepare Annual Product Review documentation for all SPL marketed products; ensure timely completion.
• Draft and verify customer-related Quality Agreements and monitor compliance.
• Investigate process deviations, product failures, customer complaints or facility incidents; approve minor deviations and CAPAs.
• Participate in Material Review Board and address all customer communications.

Skills

Quality Systems

Coaching

Cross-functional leadership

cGMP knowledge

Investigation management

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 SupervisorPosition SummaryResponsible 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: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/documentsCompiles 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 preferredExperience:10+ years of experience, 15+ years preferredHistory of developing Quality Systems’ teams’ skills with examples of coaching to goals, identifying strengths, mentoring, encouraging cross-functional collaborationExperience with professional, transparent compliance engagement with external authoritiesDemonstrate experience in inspection, inspection readiness, coordination, and proper documentation. Coaching team experts to speak on documents as needed.Experience in relationships with managing consultantsExperience managing metrics reporting for technical aspects, navigating change controlExperience managing the needs for annual product reviews, vendor auditsExperience escalating issues to solve problemsCoach sales to understand complianceWHY 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.