GMP Change Control Lead | Lab Quality & Compliance

Eurofins; West Point (PA); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical coverage

Dental coverage

Vision coverage

Life insurance

Disability insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins Scientific seeks a senior GMP Change Control Lead to drive complex change initiatives across multiple departments. You will own change activities, supervise SPR reviews, and ensure adherence to SOPs and regulatory requirements.

The role demands strong analytical skills, technical writing, and leadership in a GMP environment, with US work authorization. West Point, PA area offers full-time employment with comprehensive benefits.

Qualifications

• Bachelor’s degree or higher in Life Sciences or related field.
• 5+ years of GMP-related pharma/biologics laboratory operations or quality systems.
• Extensive GMP laboratory, quality systems, or pharma industry experience.
• Proven expertise in change control, investigations, quality systems, and regulatory compliance.
• Experience leading complex initiatives across multiple departments.
• 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 sponsorship.

Responsibilities

• Execute GMP change control processes for laboratory testing.
• Own analytical change activities across multiple change control requests with SPR as SME.
• Ensure changes comply 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 planning, implementation, and verification.
• Develop and implement strategic improvements to change management processes.
• Review and approve complex change records and supporting docs.
• Lead root cause investigations for quality and compliance issues.
• Interpret regulatory expectations and develop solutions for inspection readiness.
• Author and review technical reports, procedures, and regulatory support docs.
• Provide mentoring and technical consultation to lab and QA staff.

Skills

Analytical skills

Problem solving

Leadership

Technical writing

Stakeholder communication

Regulatory compliance

Change control

Education

Bachelor’s degree in Life Sciences, Biology, Chemistry, Microbiology, or related field

Job description

Eurofins Scientific seeks a senior GMP Change Control Lead to drive complex change initiatives across multiple departments. You will own change activities, supervise SPR reviews, and ensure adherence to SOPs and regulatory requirements.

The role demands strong analytical skills, technical writing, and leadership in a GMP environment, with US work authorization. West Point, PA area offers full-time employment with comprehensive benefits.