Compliance Manager GMP

Work Schedule

Environmental Conditions

Job Description

Join Us as a Compliance Manager Driving GMP and ISO Excellence

The Compliance Manager is responsible for leading and supporting quality and compliance activities for GMP laboratories with a primary focus on achieving and sustaining ISO/IEC 17025 and ISO 13485 certifications. This role provides oversight of quality system development inspection readiness and certification audit management to ensure alignment with GMP and applicable regulatory and accreditation requirements.

The ideal candidate will serve as a key quality partner to laboratory operations and cross-functional teams driving quality system maturity risk mitigation and sustained compliance in a regulated laboratory environment.

What Youll Do:

• Lead and coordinate GMP laboratory readiness activities to support ISO/IEC 17025 and ISO 13485 certification and ongoing compliance.

• Drive the development implementation and maintenance of quality system documentation including SOPs policies quality manuals and training materials.

• Serve as the primary point of contact for certification audits surveillance audits and inspection readiness activities.

• Partner with laboratory operations quality and regulatory stakeholders to plan and execute certification and recertification activities.

• Lead and support deviation management root cause analysis and CAPA development to ensure effective and sustainable remediation.

• Maintain compliance documentation metrics and audit records in alignment with GMP and ISO requirements.

• Support internal audits external audits and regulatory inspections as a subject matter expert (SME) for GMP laboratory compliance.

• Deliver training and guidance to laboratory and support teams on GMP and ISO requirements and quality system expectations.

• Analyze compliance and audit trends to identify risks drive continuous improvement and support strategic quality initiatives.

Education & Experience Requirements:

• Bachelors degree in life sciences chemistry engineering or a related scientific discipline.

• 8 years of experience in a GMP-regulated laboratory or quality environment.

• Hands-on experience supporting ISO/IEC 17025 and/or ISO 13485 certification efforts.

• Strong working knowledge of GMP regulations and laboratory quality systems.

• Proven experience in deviation management root cause analysis and CAPA.

• Demonstrated ability to work cross-functionally and influence stakeholders in a matrixed organization.

• Experience supporting audits and inspections in a regulated laboratory environment.

• Experience with electronic quality management systems (eQMS) such as Veeva Vault TrackWise or equivalent is a plus.

In some cases an equivalency consisting of a combination of appropriate education training and/or directly related experience may be considered.

Knowledge Skills Abilities:

• Thorough knowledge of GMP regulations and ISO laboratory standards.

• Strong understanding of laboratory operations quality systems and inspection readiness.

• Excellent written and verbal communication skills.

• Strong leadership organizational and problem-solving abilities.

• Ability to assess risk prioritize activities and manage multiple initiatives simultaneously.

• High attention to detail and a continuous improvement mindset.

• Strong digital literacy and ability to learn and leverage quality systems and tools.

• Ability to work independently and collaboratively in a fast-paced environment.

• Flexibility and adaptability in a changing regulatory landscape.

• Ability to qualify for and maintain a corporate credit card for business travel.

Why Join Us

At Thermo Fisher Scientific youll be part of a global organization committed to quality integrity and scientific excellence. This role offers the opportunity to play a key part in enabling GMP laboratories to achieve critical ISO certifications and sustain compliance directly supporting our mission to enable our customers to make the world healthier cleaner and safer.

Work Environment:

Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate receive and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary and/or standing for typical working hours.
• Able to lift and move objects up to 25 pounds.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• May have exposure to potentially hazardous elements including infectious agents typically found in healthcare or laboratory environments.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

Apply today and help shape the future of GMP laboratory compliance!

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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