Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
$147.5k - $221.3kVertex Pharmaceuticals Incorporated
Job Description General 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 culture. Key Duties and Responsibilities: Responsible for inspection readiness and compliance programs for external operations. Works cross-functionally and cross-company to ensure sites achieve and maintain a state of inspection readiness. Drive identification and resolution of issues, gaps and risks through collaboration with operational areas, assessments, audits, and evaluation of trends. Support and oversee inspection execution including responses and closure of CAPAs. Collaboration and Integration: Serve as an integrator across multiple functions, fostering collaboration and knowledge sharing. Develop trusted partnerships with external sites. Drive optimization, continuous improvement, and operational excellence to enhance processes. Report inspection readiness status including risks to leadership and governance forums Knowledge and Skills: Knowledge of regulatory requirements and inspection expectations globally Experience in multiple modalities preferred Strong technical knowledge including but not limited to: inspection management and risk management Continuous improvement experience such as six sigma or lean Proven ability to lead improvement projects and project teams and organize various teams and forums Superb facilitation, Communication, and Coaching/influencing skills with proven ability to lead teams Proven ability to identify and analyze performance indicators. Education and Experience: Bachelor's degree in a scientific discipline, or allied health field or equivalent degree 8+ years of relevant experience Travel requirement: up to 10-20% including international travel possible Hybrid-Eligible Roles In this Hybrid-Eligible role, you can choose to be designated as:
- Hybrid : work remotely up to two days per week; or select
- On-Site : work five days per week on-site with ad hoc flexibility.
- Hybrid : work remotely up to two days per week; or select
- On‑Site : work five days per week on‑site with ad hoc flexibility.
- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and compliance of external... ...10-20% including international travel possible Hybrid-Eligible RolesIn this Hybrid-Eligible role, you...SuggestedFull timeSummer 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... ...knowledge, and Lean/six sigma experience, with hybrid-eligible work arrangements and travel up to 20%...Suggested
- ...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and... ...including processes and associated governance across all GMP areas... ...10% Travel may be required#LI-hybrid #LI-JS1Pay Range:$184,600 - $2...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week
$160.6k - $240.8k
...Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for... ...identifying and communicating compliance risks and overseeing... ...risks, real-time study inspection readiness oversight, and collaboratively... ...more.Flex Designation:Hybrid-Eligible Or On-Site...SuggestedFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$156.6k - $234.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for... ...quality assurance and compliance. The incumbent is... ...functions for proactive inspection readiness across assigned programs... ...more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex...SuggestedFull timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week- Vertex Pharmaceuticals Incorporated is seeking a CMC Quality Compliance Director to lead inspection readiness and drive global quality governance across GMP areas... ...CMOs. Travel up to 5-10% may be required, with a hybrid/on-site work design in the Boston area. #J-18808-...
$160k - $180k
...single day. If you’re ready to be part of a... ...About the Role As the Associate Director, GMP Quality , reporting to the Head... ...supporting Supplier compliance. In this role you... ...functional teams such CMC, Regulatory and... ...Support Pre-Approval Inspection readiness for NDA /...Work experience placementWork at officeFlexible hours$200k - $217k
...strategic, and hands-on Associate Director, GMP Quality Drug Product to... ...to ensure compliance, product quality, and... ...qualification, audit readiness, manufacturing oversight... ...global regulatory inspections and submissions,... ...is based in Boston, Hybrid with 3 days onsite....Full timeContract workFor contractors$120 - $170 per hour
Associate Director, Clinical Program Quality Leader Base pay range: $120.00/hr - $170.00/hr... ...Location: Cambridge, MA (Hybrid - 2 days onsite in a... ...with the overall goal of inspection readiness. Serves as a Strategic... ...quality and compliance risks to key stakeholders...Temporary workFor contractorsWork at officeImmediate startNight shift2 days per week$153.9k - $230.9k
...DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced... ...of quality assurance and compliance. The Associate Director... ...formulation, filling, inspection, and supporting... ...Support batch disposition readiness through review of manufacturing...Full timeSummer workFlexible hoursShift work$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be... ...and sustaining a global quality compliance framework across R&D and bringing... ...regulatory standards while driving inspection readiness, vendor oversight, proactive risk...Work experience placementRemote workWorldwideShift work$213.6k - $320.4k
...Summary:The Senior Director, Global Quality Systems holds a... ...Systems and Compliance and serves on major... ...ensuring readiness and sustainability... ...operating standards, inspection readiness,... ..., clinical, and CMC processes, with... ...Flex Designation:Hybrid-Eligible Or On-Site...Full timeContract workWork experience placementSummer workRemote workFlexible hours2 days per week- ...Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-... ...programs, ensuring compliance with GMP/GDP standards.... ...authoring and reviewing IND CMC submissions, managing... ...systems, supporting regulatory inspections, and collaborating with...Remote job
$153.6k - $241.34k
Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid (not remote). Relocation benefit available. Job Description The Associate Director... ...program, hosting or leading regulatory inspections, investigations, and remediation activities...Temporary workLocal areaRelocation package$155.4k - $233k
## Program Quality Associate Director, AssuranceApplylocations: Boston... ...Teams (PST), Compliance, Legal, Privacy, Internal... ...organizational readiness for internal, external, and regulatory inspections or assessments* Collaborate... ...*Flex Designation:**Hybrid-Eligible Or On-Site...Summer workRemote workFlexible hours2 days per week$94.6k - $141.8k
...DescriptionGeneral Summary:The Associate Director, GMP Operational Quality Assurance is a Quality... ...complex quality and compliance issues. The role... ...expectationsDrive Quality readiness for major development milestones... ...more.Flex Designation:Hybrid-Eligible Or On-Site...Full timeContract workSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
The RoleThe Associate Director, Quality Control Lab Automation Strategy & Digital Integration... ...includes supporting regulatory inspections, overseeing automation related... ...based on business value, compliance impact, technical readiness, resource capacity, and long-term...Permanent employmentFull timeWork at officeWork from home$160k - $240k
...Overview As an Associate Director, Device Development... ...device strategy across CMC, regulatory,... ...interaction challenges Quality, Risk & Regulatory... ...(DHF) and ensure compliance and inspection readiness Serve as SME for... ...operates in a hybrid-work model. Candidates...Full timeWork at office- Alnylam Pharmaceuticals seeks an Associate Director of Digital Quality Compliance to own and advance Quality digital capabilities. You will oversee SAP... ...lead cross-functional governance forums to enable inspection readiness and continuous #J-18808-Ljbffr Alnylam...
$180.8k - $271.2k
...Summary The Senior Director, CGT Quality Systems, Personalized... ...oversight, governance, compliance, and continuous... ...participating in key CMC Quality initiatives... ...sustainment. Support inspection readiness and audit-related activities... ...15% travel Hybrid role in Boston, MA Pay...Summer workRemote workFlexible hours2 days per week$190k - $230k
...Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences Charlestown... ...relevant Quality Agreements to ensure compliance. Lead Supplier Audits and... ...required for improvement. Act as an inspection lead and/or liaison for...Temporary workRemote workFlexible hours$160.6k - $240.8k
General Summary The Associate Director of GCP Operational QA... ...advanced GCP quality assurance oversight... ...identifying and communicating compliance risks and overseeing... ...and proactive inspection readiness activities. Key Duties... .... Flex Designation Hybrid-Eligible Or On-Site...Summer workWork at officeRemote workFlexible hours2 days per week$137.8k - $206.8k
...Senior Manager, Clinical Study Quality Lead provides study-level... ...they are conducted in compliance with Good Clinical Practice... ...compliance trend analysis, and inspection readiness. The role partners closely... ...This position is on-site or hybrid and is not eligible for a...Full timeSummer workRemote workFlexible hours2 days per week- Vertex Pharmaceuticals is seeking an Associate Director, GMP Operational Quality in Boston to oversee team activities and ensure quality deliverables... ...requires comprehensive knowledge of quality assurance and compliance principles. You will lead a team responsible for GMP...
- ...solutions provider is seeking an Associate Director, Clinical Program Quality Leader in Cambridge, MA. The... ...research programs, ensuring inspection readiness and GCP compliance. A minimum of 10 years in the... ...skills are required. This hybrid role offers a competitive hourly...Hourly pay
$172k - $194k
...an experienced team ready to take action because... ...responsible for providing CMC quality oversight of drug... ...hiring the Associate Director, Quality Operations in... ...other regulatory agency inspections. Required Qualifications... ...providers to ensure compliance with current regulations...Contract workLocal areaRemote work$250k - $273k
The Senior Director, Quality Compliance is responsible for providing strategic leadership... ..., product complaints, and inspection readiness, and partners cross-... ...-based employees follow a hybrid schedule of 4 days in the... ...regions.Collaborate with CMC, Regulatory Affairs, Clinical...Work at officeRemote work$166.4k - $249.6k
## Associate Director, Regulatory CMC, BiologicsApplylocations: Boston, MAtime type: Full... ..., and delivering high-quality regulatory submissions, while... ...Commitment to quality and compliance* May include people... ...more.**Flex Designation:**Hybrid-Eligible Or On-Site Eligible...Summer workRemote workFlexible hours2 days per week$160k - $240k
...Opportunity OverviewAs the Associate Director, GCP/GLP/GVP QA, you will... ...oversee GCP activities, ensure compliance and quality execution of clinical... ...with GCP health authority inspections, assist clinical teams in... ...Massachusetts. Rhythm operates in a hybrid-work model. Candidates...Contract workWork at officeImmediate startNight shift$266k - $344k
...Summary: The Senior Director, GCP Quality Assurance provides strategic... ..., and reported in compliance with applicable regulatory... ...maintaining a continuous state of inspection readiness. The Senior Director... ...Arrangement & Location: Hybrid - This position follows a...Local areaFlexible hoursNight shift2 days per week
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