Manager Quality Assurance

Scientific Protein Laboratories•Waunakee, WI

2d•Onsite

About The Position

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.

Requirements

Bachelor’s degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields.
5 plus years, minimum of 2 years in management.

Nice To Haves

Master's degree or above in Pharmacy, Pharmaceutical Engineering, Biology, Chemistry, or related fields
10+ years, minimum of 2 years in management.

Responsibilities

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.
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.
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.
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.
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.
Support internal and external audits and regulatory inspections.
Ensure timely development, implementation, and closure of corrective actions arising from audit and inspection findings.