GMP Compliance Lead

GMP Compliance LeadWork ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, Office, WarehouseJob DescriptionLocation: Ridgefield, New Jersey Sterile Fill-Finish & Packaging SiteOur 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 Scientific's 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 360,000 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.As part of the Thermo Fisher Scientific team, you'll 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 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.A Day in the LifeContribute 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 SuccessEducationBachelor's degree in Science, Engineering, or related discipline requiredAdvanced degree preferredExperienceMinimum 5+ years of experience in GMP-regulated pharmaceutical or biologics manufacturing environmentsHands-on experience hosting FDA, EMA, and/or MHRA inspections and client auditsDemonstrated experience leading CAPA programs, mock inspections, and self-inspection frameworksStrong experience in aseptic manufacturing and QC laboratory operationsExposure to device/combination products and packaging/serialization processes preferredExperience working with electronic quality systems (Trackwise, eDMS, SFLMS, or similar)Knowledge, Skills, AbilitiesKnowledgeStrong command of 21 CFR Parts 11/210/211/820, EU GMP Annex 1/11, ISO 13485, ICH Q9/Q10, and GAMP 5In-depth understanding of ALCOA(+) data integrity principlesKnowledge of MES/eBR, LIMS, CDS/Empower, ERP, environmental monitoring systems, and serialization platformsSkillsExcellent inspection hosting and audit facilitation skillsStrong analytical and risk-based problem-solving capabilitiesEffective cross-functional leadership and stakeholder influenceClear, concise written and verbal communication skillsProficiency in quality management software and electronic documentation systemsAbilitiesAbility to remain calm and decisive under inspection pressureAbility to coach and mentor SMEs and junior team membersAbility to manage multiple priorities in a fast-paced GMP environmentSystems-thinking mindset across aseptic manufacturing, laboratory operations, device compliance, and packaging processesStrong adaptability and continuous improvement orientationPhysical Requirements / Work EnvironmentPosition requires onsite presence in Ridgefield, NJAbility to participate in extended inspection activities, including walking manufacturing areas and supporting audit backroom operationsExcellent BenefitsBenefits & Total Rewards | Thermo Fisher ScientificMedical, Dental, & Vision benefits effective Day 1Paid Time Off & Designated Paid HolidaysRetirement Savings PlanTuition ReimbursementAnnual incentive plan bonusThermo 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 BenefitsThe salary range estimated for this position based in New Jersey is $112,500.00$168,750.00.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 programsEmployee assistance and family support programs, including commuter benefits and tuition reimbursementAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave