GMP Compliance Manager

Work Schedule

Environmental Conditions

Job Description

GMP Compliance Manager

Division / Site Specific Information

Location: Ridgefield New Jersey Sterile Fill-Finish & Packaging Site

Our state-of-the-art sterile fill-finish and packaging facility in Ridgefield NJ is dedicated to meeting the growing needs of biotech and pharmaceutical drug developers. With expanded capabilities in pre-filled syringe and liquid vial manufacturing the site increases U.S. capacity to manufacture the medicines patients rely on every day.

As part of Thermo Fisher Scientifics global network Ridgefield complements our world-class contract development and manufacturing services and strengthens our sterile fill-finish footprintnow spanning seven sites worldwide including three in the U.S. (Greenville NC; Plainville MA; and Ridgefield NJ). Strategically located along the East Coast to streamline logistics and attract top talent the 360000 sq. ft. Ridgefield site plays a vital role in the global pharmaceutical supply chain with products distributed to more than 67 countries across all continents.

Discover Impactful Work

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer.

As a GMP Compliance Manager you will serve as a key leader within the Quality organization driving inspection readiness and compliance excellence across aseptic manufacturing quality control laboratories device/combination products and packaging operations. You will provide technical expertise lead cross-functional quality initiatives and ensure robust regulatory adherence in alignment with global GMP standards.

Discover Impactful Work

As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and a GMP Compliance Manager you will serve as a key leader within the Quality organization driving inspection readiness and compliance excellence across aseptic manufacturing quality control laboratories device/combination products and packaging operations. You will provide technical expertise lead cross-functional quality initiatives and ensure robust regulatory adherence in alignment with global GMP role offers the opportunity to directly influence product quality regulatory compliance and operational excellence while supporting therapies that improve and save lives.

A Day in the Life

• Contribute to and support execution of the Ridgefield site Internal Self-Inspection Program including development of annual risk-based inspection plans covering aseptic operations QC labs packaging/serialization warehousing and Quality Systems.

• Develop and maintain compliance guidelines aligned with FDA EMA and MHRA expectations including EU GMP Annex 1 & 11 21 CFR Parts 11/210/211/820 ISO 13485 GAMP 5 ICH Q9/Q10 and corporate standards.

• Lead internal self-inspections GEMBA walks and ad-hoc compliance walk-throughs; document observations with appropriate risk ratings and supporting evidence.

• Drive remediation and continuous improvement initiatives by facilitating root cause analysis and authoring/overseeing CAPAs with defined timelines and effectiveness checks.

• Track compliance commitments to closure and communicate progress risks and trends to site leadership.

• Build and maintain inspection readiness playbooks including room-by-room and system-by-system preparation strategies.

• Coordinate and lead mock inspections and targeted deep-dive assessments (aseptic behaviors environmental monitoring data integrity batch record completeness audit trail controls serialization reconciliation etc.).

• Support external inspections and client audits including backroom operations document retrieval redaction SME coaching and real-time issue triage.

• Prepare and present audit findings and related compliance updates at internal and client meetings.

• Support post-inspection responses regulatory commitments and follow-ups to ensure timely and defensible submissions.

• Operate and support electronic quality systems (Trackwise eDMS SFLMS and related tools) to ensure compliance and data integrity.

• Lead or support risk assessments and change control activities.

• Provide GxP consultation to project teams and external clients.

• Design deliver and monitor audit and inspection-related training; mentor junior colleagues as a qualified trainer.

• Support inspection readiness metrics and governance processes; analyze KPIs and present dashboards and trend analyses to leadership.

• Promote strong ALCOA() data integrity practices across electronic and hybrid systems including MES/eBR LIMS CDS/Empower serialization systems and audit trail review programs.

Keys to Success

Education

• Bachelors degree in Science Engineering or related discipline required

• Advanced degree preferred

Experience

• Minimum 5 years of experience in GMP-regulated pharmaceutical or biologics manufacturing environments

• Hands-on experience hosting FDA EMA and/or MHRA inspections and client audits

• Demonstrated experience leading CAPA programs mock inspections and self-inspection frameworks

• Strong experience in aseptic manufacturing and QC laboratory operations

• Exposure to device/combination products and packaging/serialization processes preferred

• Experience working with electronic quality systems (Trackwise eDMS SFLMS or similar)

Knowledge Skills Abilities

Knowledge

• Strong command of 21 CFR Parts 11/210/211/820 EU GMP Annex 1/11 ISO 13485 ICH Q9/Q10 and GAMP 5

• In-depth understanding of ALCOA() data integrity principles

• Knowledge of MES/eBR LIMS CDS/Empower ERP environmental monitoring systems and serialization platforms

Skills

• Excellent inspection hosting and audit facilitation skills

• Strong analytical and risk-based problem-solving capabilities

• Effective cross-functional leadership and stakeholder influence

• Clear concise written and verbal communication skills

• Proficiency in quality management software and electronic documentation systems

Abilities

• Ability to remain calm and decisive under inspection pressure

• Ability to coach and mentor SMEs and junior team members

• Ability to manage multiple priorities in a fast-paced GMP environment

• Systems-thinking mindset across aseptic manufacturing laboratory operations device compliance and packaging processes

• Strong adaptability and continuous improvement orientation

Physical Requirements / Work Environment

• Position requires onsite presence in Ridgefield NJ

• Ability to participate in extended inspection activities including walking manufacturing areas and supporting audit backroom operations

Excellent Benefits

Benefits & Total Rewards Thermo Fisher Scientific

• Medical Dental & Vision benefits effective Day 1

• Paid Time Off & Designated Paid Holidays

• Retirement Savings Plan

• Tuition Reimbursement

• Annual incentive plan bonus

Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We foster a culture of integrity intensity involvement and innovation.

Relocation assistance is not provided.

Must be legally authorized to work in the United States now or in the future without sponsorship.

Must be able to pass a comprehensive background check which includes a drug screening.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager