Manager Manufacturing Compliance and Training

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 – Manufacturing Compliance and Training.

The Manufacturing Manager, Compliance & Training is responsible for leading compliance and training activities within the manufacturing organization to ensure operations are performed safely, consistently, and in full compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company procedures. This role partners closely with Manufacturing Operations, Quality Assurance, Quality Control, Engineering, Validation, and Supply Chain to maintain an inspection-ready manufacturing environment, strengthen quality culture, and ensure personnel are properly trained and qualified to execute GMP manufacturing activities. The position focuses on driving operational compliance, improving procedural adherence, enhancing training effectiveness, and supporting continuous improvement initiatives across manufacturing operations.

Responsibilities include:

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Manufacturing Compliance Oversight

• Ensure manufacturing operations comply with: cGMP requirements, FDA and global regulatory standards, Site procedures and policies, Data integrity expectations
• Monitor manufacturing compliance performance through: On the floor observations, Documentation reviews, Process audits
• Partner with Production leadership to maintain a state of inspection readiness.
• Support manufacturing investigations related to: Deviations, Human error, Procedural non-compliance, Batch record errors, Documentation practices
• Drive timely and effective corrective and preventive actions (CAPAs).
• Identify compliance risks and implement mitigation strategies within manufacturing operations.
• Lead initiatives to improve right-first-time performance and reduce repeat deviations

Training Program Leadership

• Manage the manufacturing training program for operators, leads, and supervisors.
• Ensure employees are trained, qualified, and authorized prior to performing GMP activities independently.
• Develop and maintain: Manufacturing training program, Onboarding and qualification programs, OJT (On-the-Job Training) programs, Annual GMP refresher training, Role-specific certification requirements
• Oversee training compliance and maintain accurate training records within the Learning Management System (LMS).
• Collaborate with SMEs and department leaders to create and revise: SOP training content, Manufacturing work instructions, Visual aids, Training assessments
• Evaluate training effectiveness through: Floor observations, Operator performance, Deviation trends, Audit findings, Knowledge assessments
• Drive continuous improvement in training delivery and employee engagement.

Operational Support

• Partner with manufacturing supervisors and managers to reinforce procedural adherence on the production floor.
• Support batch execution excellence through: Real-time coaching, GMP observations, Documentation reviews, Escalation of compliance concerns
• Assist with implementation of: New procedures, Process improvements, Equipment qualification support, Manufacturing readiness activities
• Participate in shift meetings, operational reviews, and quality discussions.

Leadership Responsibilities

• Lead and develop manufacturing compliance and training personnel.
• Foster a culture of: Accountability, Quality ownership, Attention to detail, Procedural discipline, Continuous improvement
• Coach employees and leaders on GMP expectations and manufacturing best practices.
• Serve as a manufacturing SME for compliance and training-related matters.
• Promote open communication and escalation of quality concerns.

Additional Responsibilities

• Strong attention to detail and organizational skills.
• Proficiency with Microsoft Excel and other data entry tools.
• Familiarity with deviation and change control systems (e.g., ComplianceWire, TrackWise, Veeva) is a plus.
• Effective communication skills and ability to collaborate across departments.

Job Requirements and Qualifications:

Education: Associates degree required, Bachelor’s degree or above preferred

Experience: 5+ years of experience in a GMP-regulated manufacturing or QA support role required. 1+ year of experience in a GMP-regulated QA or Training support role

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.