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 Manager Quality Assurance.
Responsible for organizing on-site quality supervision, managing quality-related investigations and CAPA execution, and organizing batch record review and product release activities. Ensure that production operations and related quality activities comply with GMP and company quality standards, safeguard product quality and compliance, and drive continuous improvement of the quality system and team capability.
Essential Responsibilities
On-Site Quality Oversight
- Plan, organize, and oversee on-site quality supervision activities to ensure GMP compliance and effective execution of procedures.
- Review and approve quality supervision documentation, ensuring timely identification, escalation, and resolution of quality issues.
- Review and assess original GMP records, including deviation investigations, change controls, and equipment malfunction documentation.
- Oversee and authorize in-process control (IPC) release activities in accordance with approved procedures.
Quality Investigations and CAPA Management
- Establish, organize, and maintain compliant processes for quality investigations and CAPA execution.
- Provide technical oversight, guidance, and review of deviation and customer complaint investigations conducted by investigators.
- Ensure investigations and CAPAs are completed on time, thoroughly documented, and effectively closed.
- Monitor and track CAPA implementation and effectiveness to drive continuous improvement of the quality system.
Batch Record Review and Product Release
- Establish and maintain procedures governing batch record review and product disposition.
- Ensure timely and thorough review of batch production and testing records, with prompt resolution of discrepancies.
- Organize and oversee product release activities, ensuring compliance with regulatory requirements while maintaining operational efficiency.
Cross-Functional Quality Leadership
- Act as a primary Quality interface with Operations, Quality Control, and Engineering functions.
- Facilitate cross-functional resolution of quality issues and provide GMP guidance to support operations.
- Report quality metrics, deviation and CAPA trends, and improvement initiatives to management.
- Provide quality and compliance input for cross-functional projects and process improvement initiatives.
Team Leadership and Resource Management
- Lead and manage on-site QA and Operations On-Site QA teams, defining roles, responsibilities, and performance expectations.
- Coach and develop team members to strengthen competencies in investigations, CAPA management, and GMP documentation.
- Assess workload and resource needs, adjusting staffing and priorities to ensure business and compliance requirements are met.
Additional Responsibilities
Audit and Inspection Support
- Support internal and external audits and regulatory inspections.
- Ensure timely development, implementation, and closure of corrective actions arising from audit and inspection findings.
Job Requirements and Qualifications:
Education: Required: Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields. Preferred: Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields
Experience: Required: 5 plus years, minimum of 2 years in management.
Preferred: 10+ years, minimum of 2 years in management.
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!
Skills Required
- Bachelor's degree in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related field
- Master's degree in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related field
- 5+ years of relevant experience
- Minimum 2 years of management experience
- Experience with cGMP and GMP compliance
- Experience managing quality investigations, deviation investigations, and CAPA processes
- Experience with batch record review, in-process control (IPC) release, and product disposition
- Experience supporting internal and external audits and regulatory inspections
- Experience coaching and leading QA teams and managing resources
- Experience with change control and equipment malfunction documentation review
What We Do
Scientific Protein Laboratories (SPL) is a world leader in biosourced pharmaceuticals, specializing in the development and cGMP-compliant manufacturing of high-quality active pharmaceutical ingredients (APIs). The company is among the largest commercial suppliers of pancreatic enzymes, heparin and its analogs, and other naturally derived products, serving the pharmaceutical, veterinary, and food industries globally.
