GMP Compliance Lead

Thermo Fisher Scientific•Teterboro, NJ

1d•Onsite

About The Position

As a GMP Compliance Lead, 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. This role offers the opportunity to directly influence product quality, regulatory compliance, and operational excellence while supporting therapies that improve and save lives.

Requirements

Bachelor’s degree in Science, Engineering, or related discipline required
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
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
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
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
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.

Nice To Haves

Advanced degree preferred
Exposure to device/combination products and packaging/serialization processes preferred
Experience working with electronic quality systems (Trackwise, eDMS, SFLMS, or similar)

Responsibilities

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.

Benefits

Medical, Dental, & Vision benefits effective Day 1
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Annual incentive plan bonus
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