GMP Change Control Lead – Life Sciences

Eurofins; West Point (PA); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life and disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins is seeking a GMP Change Control Lead in West Point, PA to drive change control processes across laboratory testing. You will own analytical change activities, coordinate cross-functional teams, and ensure compliance with SOPs and regulations.

The role demands experience in GMP, quality systems, and regulatory affairs, with strong leadership and communication skills. The position offers full-time hours, extensive benefits, and opportunities to improve change management processes across

Qualifications

• Bachelor’s degree in Life Sciences, Biology, Chemistry, Microbiology, or related scientific discipline.
• Minimum 5 years of pharmaceutical, biologics, laboratory operations, quality systems, or GMP experience.
• Extensive GMP laboratory, quality systems, or pharmaceutical industry experience.
• Proven expertise in change control, investigations, quality systems, and regulatory compliance.
• Experience leading complex technical initiatives across multiple departments.
• Demonstrated ability to evaluate and implement new technologies and methodologies.
• Strong analytical, problem-solving, organizational, and leadership skills.
• Excellent technical writing and stakeholder communication abilities.
• Authorization to work in the United States indefinitely without restrictions or sponsorship.

Responsibilities

• Execute GMP change control processes for various laboratory testing
• Own analytical change activities across multiple change control requests with cross-functional communication
• Ensure change control complies with specifications, SOPs, and regulations
• Provide scientific and technical leadership for complex change initiatives
• Evaluate regulatory, compliance, operational, and technical impacts of changes
• Lead cross-functional teams through change planning, implementation, and verification
• Develop and implement improvements to change management processes
• Review and approve complex change records, assessments, and documentation
• Lead root cause investigations and resolution of quality issues
• Interpret regulatory expectations and develop compliant solutions for inspections readiness
• Author and review technical reports, procedures, strategies, and regulatory support documentation
• Mentor and consult laboratory and quality personnel

Skills

GMP

Change control

Quality systems

Investigations

Leadership

Regulatory compliance

Technical writing

Stakeholder communication

Problem solving

Analytical thinking

Education

Bachelor’s degree in Life Sciences/related field

Job description

Eurofins is seeking a GMP Change Control Lead in West Point, PA to drive change control processes across laboratory testing. You will own analytical change activities, coordinate cross-functional teams, and ensure compliance with SOPs and regulations.

The role demands experience in GMP, quality systems, and regulatory affairs, with strong leadership and communication skills. The position offers full-time hours, extensive benefits, and opportunities to improve change management processes across