Supervisor, GMP Manufacturing

GMP Manufacturing Supervisor

The GMP Manufacturing Supervisor is responsible for leading and managing shift operations to ensure safe, compliant, and efficient manufacturing of medical devices. This role drives production performance, quality compliance, and continuous improvement while developing team performance and capability across GMP Associate levels and supporting Engineering and Quality initiatives.

Safety

• Ensure strict adherence to all safety policies, PPE requirements, and Controlled Unclassified Area (CNC) protocols.
• Conduct safety walkthroughs and address hazards or behavioral risks promptly.
• Lead incident investigations and corrective actions in partnership with EHS.

Quality & Compliance

• Ensure full compliance with GMP, GDP, FDA, ISO 13485, and Controlled Unclassified Area (CNC) standards.
• Verify production documentation accuracy and review quality metrics.
• Support and lead investigations (NCE, CAPA, PIR, etc.) to ensure timely closure.

Manufacturing & Delivery

• Oversee shift output across all manufacturing operations (assembly, packaging, component loading, etc.).
• Monitor production schedules, staffing levels, and material flow to minimize downtime.
• Ensure proper use of equipment and escalation of technical issues to Engineering.
• Publish shift performance reports (quality, productivity, downtime, waste, etc.).

Leadership & People Management

• Conduct performance reviews, coaching, and corrective actions as needed.
• Support hiring, onboarding, and workforce planning with HR and leadership.
• Hold regular shift meetings and communicate goals, priorities, and updates.

Training & Development

• Ensure associates are trained and qualified per the cross-training matrix.
• Reinforce GMP, GDP, safety, and lean principles through daily coaching.
• Partner with GMP Trainer to strengthen onboarding and skill development.

Continuous Improvement

• Lead lean initiatives (5S, Kaizen, problem-solving events).
• Identify and implement process improvements to increase efficiency and reduce waste.
• Collaborate with Engineering and Quality on validation, testing, and improvements.

Company Values

• Model professionalism, accountability, and teamwork.
• Foster a culture of continuous learning and operational excellence.
• Uphold company policies and support additional duties as required.

Additional Duties and Responsibilities

• The responsibilities outlined in this job description are not exhaustive. Duties may be adjusted, expanded, or reassigned as necessary to support evolving business requirements.

Qualifications

• High school diploma or equivalent required.
• Bachelor's degree in a technical, engineering, business, or related field preferred; relevant manufacturing leadership experience may be considered in lieu of a degree.
• 3–5 years of manufacturing experience, including some experience in a supervisory or team lead capacity.
• Demonstrated ability to manage people, production flow, and performance metrics.
• Strong understanding of GMP, GDP, and regulated manufacturing practices strongly preferred.

Physical Requirements

• Stand for extended periods; perform walkthroughs on production floor.
• Wear Controlled Unclassified Area attire (gown, mask, gloves) as needed.
• Lift/move up to 25 lbs occasionally.