GMP Change Control Lead - Life Sciences

Eurofins PSS Insourcing Solutions; West Point (PA); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision coverage

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions in West Point, PA is seeking a Change Control Lead to execute GMP change control processes for laboratory testing, owning multiple change events from start to finish. Responsibilities include reviewing records, coordinating SPR, and ensuring alignment with SOPs.

This role provides scientific and technical leadership, evaluates regulatory and operational impacts, leads cross‑functional teams, and mentors staff while ensuring inspection readiness and

Qualifications

• Bachelor’s degree in Life Sciences or related field.
• 5+ years GMP pharma or biologics experience.
• Extensive GMP lab experience and quality systems.
• Proven change control, investigations, regulatory compliance.
• Experience leading cross-functional initiatives.
• Ability to adopt new technologies and methods.
• Strong analytical, problem-solving and leadership skills.
• Excellent technical writing and stakeholder comms.
• Authorized to work in the United States without sponsorship.

Responsibilities

• Execute GMP change control processes for laboratory testing.
• Own analytical change activities and coordinate milestones; SPR as SME.
• Ensure change control aligns with SOPs, specs, and regulations.
• Provide scientific and technical leadership for change initiatives.
• Evaluate regulatory, compliance, operational, and technical impacts.
• Lead cross-functional teams through change planning and execution.
• Develop and implement improvements to change management.
• Review complex change records and supporting documentation.
• Lead root-cause investigations for quality issues.
• Interpret regulatory expectations and propose solutions for inspections.
• Author and review technical reports, procedures, and regulatory docs.
• Mentor laboratory and quality personnel.

Skills

GMP

Change control

Regulatory compliance

Quality systems

Leadership

Technical writing

Analytical thinking

Cross-functional collaboration

Education

Bachelor’s degree in Life Sciences

Job description

Eurofins USA PSS Insourcing Solutions in West Point, PA is seeking a Change Control Lead to execute GMP change control processes for laboratory testing, owning multiple change events from start to finish. Responsibilities include reviewing records, coordinating SPR, and ensuring alignment with SOPs.

This role provides scientific and technical leadership, evaluates regulatory and operational impacts, leads cross‑functional teams, and mentors staff while ensuring inspection readiness and