Director of GMP Quality & Inspection Readiness
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated is seeking a CMC Quality Compliance Director to lead inspection readiness and drive global quality governance across GMP areas. You will shape strategies, partner with cross-functional teams, and ensure scalable programs for current and emerging modalities. The role emphasizes risk-based decision making, coaching of staff, and collaboration with internal sites and CMOs. Travel up to 5-10% may be required, with a hybrid/on-site work design in the Boston area. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
$156.6k - $234.8k
...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development... ...Engages with study teams and functions for proactive inspection readiness across assigned programs.Provides inspection support...SuggestedFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$160k - $180k
Associate Director GMP Quality Reporting to the Head of GMP Quality, you will oversee GMP activities... ...during internal and regulatory inspections. This role will be based out of our... ...occurs Support pre‑approval inspection readiness for NDA/commercial launch Review...SuggestedWork experience placementWork at officeFlexible hours$200k - $217k
..., strategic, and hands-on Associate Director, GMP Quality Drug Product to serve as the end-to-... ...ensuring successful qualification, audit readiness, manufacturing oversight, and quality... ...systems, support global regulatory inspections and submissions, drive continuous...SuggestedFull timeContract workFor contractors$103.5k - $162.69k
...knowledge.Job DescriptionTitle: Manager, Quality Systems & Data Analytics, R&D GMP QualityLocation: Lexington,... ...Systems, audits, deviations, CAPAs, inspections, supplier quality, laboratories,... ...making, risk assessments, inspection readiness, and continuous improvement...SuggestedMinimum wageTemporary workLocal area- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external sites including evaluating, improving, and monitoring commercial level quality compliance and quality...SuggestedFull timeSummer workRemote workFlexible hours2 days per week
- ...the Head of QA with oversight of Verastem Quality Systems and QA activities in accordance... ...current regulations and oversight of external GMP Quality operations at partner and CMO... ...organization Experience with Regulatory/Health Authority Inspections #J-18808-Ljbffr JobtailorFlexible hours
- Director, Quality Control (QC) Location: Cambridge, MA (Hybrid) Overview... ...and drive phase-appropriate GMP compliance across a growing... ...tech transfer, and later-stage readiness. Grow, mentor, and manage... ...Represent QC in regulatory inspections and ensure readiness aligned...
- A biotechnology organization is seeking an Associate Director, Global Quality to oversee global quality compliance across R&D. This role involves leading compliance projects, ensuring inspection readiness, and embedding quality processes. Candidates should have a strong...
$200k - $260k
...LinkedIn and X. We are seeking a Director/Senior Director, GMP Quality Assurance Operations. You will be... ...validation/PPQ, and commercial readiness, including BLA support. Responsibilities... ...regulatory submissions and inspections, including preparation of CMC-related...Contract workTemporary workFlexible hours$168.75k - $257.8k
Director of QualityCatalent, Inc. is a leading global contract development... ..., MA is hiring a Director of Quality who will provides leadership... ...within a pharmaceutical GMP environment required;... ...managing and fronting Regulatory Inspections from both EU and US Regulatory...Full timeContract workLocal area$213.6k - $320.4k
...DescriptionPosition Summary:The Senior Director, Global Quality Systems holds a pivotal... ...for evolution ensuring readiness and sustainability for... ...into operating standards, inspection readiness, compliance and excellenceLead... ...oversight experience (GMP and/or GCP with additional...Full timeContract workWork experience placementSummer workRemote workFlexible hours2 days per week- Vertex Pharmaceuticals Inc. seeks an Associate Director, CMC Quality Compliance and Inspection Readiness in Boston. You will own inspection readiness for external sites, drive continuous improvement of quality programs, and lead cross-functional teams to address risks and...
- Amylyx Pharmaceuticals is seeking an Associate Director, Quality Operations to oversee GMP quality across drug substance, drug product, and finished products... ...spanning IND reviews, SOP authoring, and regulatory inspections. #J-18808-Ljbffr Amylyx PharmaceuticalsContract work
$85.4k - $158.6k
Reporting:Associate Director, Quality AssuranceDescription: We are seeking an experienced Manager... ...QA Manager for Radioligand Therapy GMP Manufacturing Operations plays a critical... ...safety teams to maintain a robust, inspection-ready quality culture.Illustrative Breadth of...- Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating... ...processes and associated governance across all GMP areas. This position focuses not just on the “...Full timeWork experience placementSummer workRemote workFlexible hours2 days per week
- ...Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end... ...commercial programs, ensuring compliance with GMP/GDP standards. The role involves... ...quality systems, supporting regulatory inspections, and collaborating with internal #J-18...Remote job
$210k - $300k
...Opportunity OverviewAs the Senior Director, Analytical Development and Quality Control, you will... ...and commercial readiness.Drive innovation in analytical... ...programs.Quality Control & GMP OversightAct as Head of... ...and oversee regulatory inspections and audit readiness of...Contract workWork at office$133.8k - $200.6k
...SummaryThe Operational Area Quality Senior Manager provides quality... ..., ensuring compliance with GMP, regulatory requirements, and... ...resolution.Support regulatory inspections, customer audits, supplier audits... ...transfers, and manufacturing readiness.Experience working with...Full timeContract workSummer workRemote workFlexible hours2 days per week$94.6k - $141.8k
Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality leader and advanced technical resource responsible... ...with current regulatory expectationsDrive Quality readiness for major development milestones including IND/IMPD submissions...Full timeContract workSummer workRemote workFlexible hours2 days per week$118.4k - $177.6k
...DescriptionGeneral Summary:The Quality Manager provides... ...by overseeing data readiness and collaborating with... ...reports to the Associate Director and plays a critical... ...CAPA actions.Support GMP/GDP management reviews... ...initiatives.Audit and Inspection SupportServe as SME responder...Full timeContract workSummer workRemote workFlexible hours2 days per week$180.8k - $271.2k
General/Position Summary The Senior Director, CGT Quality Systems, Personalized Medicine provides... ...including sustainment. Support inspection readiness and audit-related activities in relation... ...patient CGT treatment journey assuring GMP requests are assessed, governed, documented...Summer workRemote workFlexible hours2 days per week- ...submission, manufacturing ramp, and product launch. We need a Director of Quality who has been here before: someone who can hold the rigor... ...for a 70-person company moving fast, ensuring we’re inspection-ready without drowning in overhead, and scaling the system as we...Day shift
- Senior Director, Quality Control (PR/602456) Boston, Massachusetts Senior Director, Quality... ...establish, build, and lead an internal GMP Quality Control laboratory while... ...deviations, CAPAs, change controls, and inspection readiness activities Collaborate with Analytical...
$168.75k - $257.8k
...life‑cycle supply. The Role Ensure the Quality function complies with Health, Safety and... ...and batch release within a pharmaceutical GMP environment required. Leadership... ...Participated in managing and fronting regulatory inspections from both EU and US regulatory agencies...Contract workLocal area$196k - $230k
...LinkedIn and Facebook.Role Summary:The Director, Quality Management Systems is a quality leader... ...programs, ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory... ...with exposure across GxPs (GCP, GLP, GMP, GVP preferred) Demonstrated...Local area$136k - $170k
...website: The Importance of the Role The Sr. Manager, Corporate Quality - GCP, will provide program-level quality oversight and... ...execution of investigator site audits, internal process audits, and inspection readiness activities. This role also drives continuous improvement in...Full time$185k - $235k
OverviewMonte Rosa Therapeutics is seeking a Director Quality GCP to provide strategic oversight of phase-appropriate Quality GCP and... ...feedback on regulatory submissions. Lead and participate in inspection readiness activities for regulatory inspections - both internally...$129k - $145k
...assembled an experienced team ready to take action because the communities... ...responsible for providing CMC quality oversight of sterile drug... ...operations. As the GMP quality expert, this role is accountable... ...or other regulatory agency inspections. Required Qualifications Bachelor...Contract workLocal areaRemote work- ...patients’ lives. About The Role The Director of Quality Operations has a critical role... ...external (vendor) audits, self‑inspections and regulatory inspection readiness meet company and applicable regulatory... ...knowledge of GxP, 21CFR, EU GMP, ICH, ISO, QSR, EUGDP and other applicable...Contract workFor contractorsLocal areaRemote workWorldwideFlexible hours
$122k - $140k
Manager, Quality Operations (no agencies please) Get AI-powered advice on this job and... ...quality documents Participate in the site inspection readiness program Support internal audit program... ...track record in effectively managing GMP‑compliant quality systems Knowledge of...Full time
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