Manager Manufacturing Compliance and Training

Scientific Protein Laboratories•Waunakee, WI

6d•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 – 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.

Requirements

Associates degree required
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

Nice To Haves

Bachelor’s degree or above preferred
Familiarity with deviation and change control systems (e.g., ComplianceWire, TrackWise, Veeva) is a plus.

Responsibilities

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, and 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, and 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 the manufacturing training program, onboarding and qualification programs, OJT (On-the-Job Training) programs, annual GMP refresher training, and 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, and training assessments.
Evaluate training effectiveness through floor observations, operator performance, deviation trends, audit findings, and 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, and escalation of compliance concerns.
Assist with implementation of new procedures, process improvements, equipment qualification support, and 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, and 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.