Associate Director, CMC Quality Compliance and Inspection Readiness (Hybrid)
$147.5k - $221.3kVertex Pharmaceuticals
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 Hybrid: work remotely up to two days per week. On-Site: work five days per week on-site with ad hoc flexibility. #LI-Hybrid #LI-AR1 Pay Range $147,500 - $221,300 Disclosure Statement The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid : work remotely up to two days per week; or select 2. On-Site : work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex’s Policy on Flex Vertex Program and may be changed at any time. Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance vrtx.com #J-18808-Ljbffr Vertex Pharmaceuticals
- 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 Incorporated is seeking an Associate Director to lead CMC Quality Compliance and Inspection Readiness. You will drive inspection readiness for... ...of experience, with travel up to 10-20% and a hybrid work arrangement allowing remote or on-site days...SuggestedRemote work
- ...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$190k - $205k
Associate Director/Director, Analytical Steward, CMC About Celea Therapeutics Celea Therapeutics... ...submissions, inspection readiness, and oversight of... ...based in Boston, Hybrid with 3 days/... ...support product quality, process robustness, regulatory compliance, and robust manufacturing...SuggestedContract work$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...Full timeWork experience placementSummer workRemote workFlexible hoursDay shift2 days per week$172k - $202k
...colleagues who are ready to join a high-... ...and enthusiastic quality control lead excited... ...You will work with CMC technical SMEs, QA... ...correctness and regulatory compliance) and in internal... ...health authority inspections and responses,... ...and developing associated limits/specifications...Work at officeLocal areaRemote work1 day per week- Vertex Pharmaceuticals LLC in Boston seeks a Director of CMC Quality Compliance to lead inspection readiness and cross-functional quality programs across GMP areas... ...aligning with Vertex’s strategic goals. This hybrid role emphasizes leadership, collaboration, and scalable...
- Lead Quality Control activities supporting clinical and commercial... ...quality control checks on CMC sections of IND, CTA, and... ...reviews Ensure compliance with deviations, change controls... ...laboratories, FDA/EMA inspections, and inspection readiness preferred Prior experience...Work at officeRemote work2 days per week
$160k - $180k
Associate Director GMP Quality Reporting to the Head of GMP Quality, you... ...supporting supplier compliance. You will collaborate with CMC, Regulatory, and Supply... ...internal and regulatory inspections. This role will be... ...‑approval inspection readiness for NDA/commercial...Work experience placementWork at officeFlexible hours$200k - $217k
Associate Director, GMP Quality Drug Product About Celea Therapeutics... ...activities to ensure compliance, product quality,... ...qualification, audit readiness, manufacturing... ...global regulatory inspections and submissions, drive... ...is based in Boston, Hybrid with 3 days onsite....Contract workFor contractors$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- ...seeking an experienced Associate Director to lead Quality Control... ...exceptional candidates. Hybrid positions require... ...checks on the CMC sections of regulatory... ...in and ensure compliance with appropriate... ..., FDA/EMA inspections, and inspection readiness is preferred. Strong...Temporary workWork at officeRemote work2 days per week
$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$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$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$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$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$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...Summer workRemote workFlexible hours2 days per week$213.6k - $320.4k
## Senior Director, Quality Systems/QMSApplylocations... ...Systems and Compliance and serves on major... ...evolution ensuring readiness and sustainability... ...standards, inspection readiness, compliance... ...preclinical, clinical, and CMC processes, with... ...up to 15%.#LI-hybrid**Pay Range:**$213...Contract workWork experience placementSummer 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$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...
$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$161.5k - $202k
...Position The Digital Quality Associate Director/Director is a... ...state of control and compliance with Formation Bio standards... ...during regulatory inspections. Responsibilities... ...support inspection readiness activities Partner... ...metro areas, with a hybrid model requiring 3 days...Work at officeLocal area3 days per week$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
...Chemistry Manufacturing Controls (CMC) Associate Director leads and executes global... ..., and delivering high-quality regulatory submissions, while... ...Commitment to quality and compliance May include people... ...much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible...Summer workRemote workFlexible hours2 days per week$185k - $225k
...Position Overview:We are seeking an Associate Director, Quality Control to lead the Beam... ...continuous state of laboratory and inspection readiness. This on-site role will provide site... ...can balance daily testing execution, compliance rigor, scientific judgment, staff development...Full time$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
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