About The Position

The GMP Area Leader serves as the frontline leader within manufacturing operations, responsible for directing daily work, leading associates, and ensuring production targets are met safely, compliantly, and efficiently. Building on the technical expertise of GMP I–III and the coaching skills of the GMP Trainer, this role combines deep process knowledge with strong leadership capabilities. The GMP Area Leader prioritizes tasks, escalates issues as needed, enforces discipline, and fosters a culture of accountability, teamwork, and continuous improvement.

Requirements

  • High school diploma or equivalent required
  • 3–5 years of experience in a GMP-regulated manufacturing environment (medical device, pharmaceutical, or biotech preferred)
  • Proven ability to lead teams, assign work, and enforce accountability.
  • Strong knowledge of GMP, GDP, FDA, and ISO 13485 standards.
  • Demonstrated expertise across all manufacturing equipment and processes.
  • Experience coaching, mentoring, or training associates.
  • Excellent organizational, communication, and interpersonal skills.
  • Ability to balance technical problem-solving with people leadership.
  • Stand for extended periods; oversee hands-on production activities.
  • Lift/move up to 25 lbs as needed.
  • Wear cleanroom attire (gown, mask, gloves) for prolonged periods.

Nice To Haves

  • advanced training, certification, or leadership coursework preferred

Responsibilities

  • Assign and direct daily work across manufacturing lines to ensure safety, quality, and output goals are achieved.
  • Prioritize production activities in alignment with schedules and supervisor guidance.
  • Monitor associate performance, provide coaching and feedback, and escalate concerns when needed.
  • Support supervisors in extending disciplinary actions, ensuring fairness and consistency.
  • Act as the first point of contact for questions, concerns, and escalations from GMP I, II, III, and Trainers.
  • Create rotations and balance shift workload.
  • Champion a strong safety culture, ensuring proper use of PPE and adherence to all procedures.
  • Identify and mitigate risks, escalating safety concerns promptly.
  • Reinforce safe machine operation and cleanroom discipline across the team.
  • Ensure all associates adhere to GMP, GDP, FDA, and ISO 13485 standards.
  • Oversee accurate completion of production and equipment documentation.
  • Verify in-process inspections and final outputs meet quality specifications.
  • Promote accountability for cleanroom discipline, documentation accuracy, and compliance.
  • Lead associates in operating and troubleshooting equipment, ensuring minimal downtime.
  • Oversee material handling, packaging, assembly, and preventive maintenance (TPM) activities.
  • Ensure cross-trained associates are effectively deployed to meet production needs.
  • Escalate complex technical or equipment issues to maintenance, engineering, or supervisors.
  • Support onboarding and ongoing training in GMP, GDP, safety, and equipment operation.
  • Maintain visibility of cross-training matrices and skill gaps across the area.
  • Act as a mentor, reinforcing technical, quality, and soft skills for GMP I–III associates.
  • Drive lean initiatives such as 5S, Kaizen, and structured problem-solving.
  • Collaborate with supervisors, quality, and engineering to identify and implement process improvements.
  • Encourage team members to contribute ideas to enhance safety, efficiency, and quality.
  • Model professionalism, accountability, and respect in all interactions.
  • Promote teamwork, communication, and trust within the area.
  • Uphold company policies and act as a role model for values-driven behavior.
  • Uphold company policies and procedures, performing additional duties as needed to support production.
  • Communicate effectively with supervisors and team members to resolve issues and ensure smooth production flow.

Benefits

  • 401(k) with up to a 6% employer match and no vesting period
  • employee stock purchase plan
  • flexible time off for salaried employees
  • accrual of three to five weeks’ vacation annually (based on tenure) for hourly employees
  • accrual of up to 64 hours (annually) of paid sick time for hourly employees
  • paid and/or floating holidays
  • parental leave
  • short- and long-term disability insurance
  • tuition reimbursement
  • health and welfare benefits
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