Associate Director, CMC Quality & Inspection Readiness
Vertex Pharmaceuticals Inc (US)
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 CAPAs. The role emphasizes collaboration with operations and external sites, regulatory knowledge, and Lean/six sigma experience, with hybrid-eligible work arrangements and travel up to 20% internationally. #J-18808-Ljbffr Vertex Pharmaceuticals Inc (US)
- 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
- Amylyx Pharmaceuticals, Inc. is seeking an Associate Director, Quality Operations to provide end-to-end quality... ...involves authoring and reviewing IND CMC submissions, managing quality systems, supporting regulatory inspections, and collaborating with internal #J-1880...SuggestedRemote job
$160k - $180k
Associate Director GMP Quality Reporting to the Head of GMP Quality, you will oversee... ...You will collaborate with CMC, Regulatory, and Supply... ...during internal and regulatory inspections. This role will be based... ...pre‑approval inspection readiness for NDA/commercial launch...SuggestedWork experience placementWork at officeFlexible hours$172k - $194k
...assembled an experienced team ready to take action because the... ...responsible for providing CMC quality oversight of drug substance... ...We anticipate hiring the Associate Director, Quality Operations in September... ...or other regulatory agency inspections. Required Qualifications...SuggestedContract workLocal areaRemote work- Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating... ...and compliance including processes and associated governance across all GMP areas. This position...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week
$156.6k - $234.8k
...Job DescriptionGeneral Summary:The Associate Director, GMP Operational Quality is responsible for oversight of team activities, development of personnel... ...with study teams and functions for proactive inspection readiness across assigned programs.Provides inspection support...Full 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. You will shape strategies, partner with cross-functional teams, and ensure scalable programs for current...
$153.9k - $230.9k
...DescriptionGeneral/Position SummaryThe Associate Director - Shift Quality Operationsis an advanced technical... ..., including formulation, filling, inspection, and supporting activities as... ...appropriately.Support batch disposition readiness through review of manufacturing...Full timeSummer workFlexible hoursShift work$180k - $195k
...and key opinion leaders. For more information, please visit Reporting to the Head of Quality, Seaport Therapeutics is seeking an experienced Associate Director, Quality Assurance CMC to manage GMP quality assurance activities supporting clinical development programs,...- Join to apply for the Associate Director, R&D Quality role at BioSpace We are seeking a highly motivated and experienced Associate Director... ...follow‑through. The successful candidate will strengthen inspection readiness, harmonize processes and job aids, and enable data‑...Work from home
$90k - $115k
Associate Director, Global Quality (R&D) Pay Range: $90,000.00 - $115,000.00 per year Travel may be required. We are partnered with a biotechnology... ...international regulatory standards while driving inspection readiness, vendor oversight, proactive risk governance, and...Work experience placementRemote workWorldwideShift work$200k - $217k
...experienced, strategic, and hands-on Associate Director, GMP Quality Drug Product to serve as the end-to... ...successful qualification, audit readiness, manufacturing oversight, and quality... ...systems, support global regulatory inspections and submissions, drive continuous compliance...Full timeContract workFor contractors$160.6k - $240.8k
Job DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for advanced quality assurance oversight... ...action plans to mitigate risks, real-time study inspection readiness oversight, and collaboratively identifying and driving...Full timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week- ...leading healthcare solutions provider is seeking an Associate Director, Clinical Program Quality Leader in Cambridge, MA. The candidate will provide... ...oversight for clinical research programs, ensuring inspection readiness and GCP compliance. A minimum of 10 years in the...Hourly pay
$142.5k - $256.5k
The RoleThe Associate Director, Quality Control Lab Automation Strategy & Digital Integration is responsible... ...This includes supporting regulatory inspections, overseeing automation related... ...value, compliance impact, technical readiness, resource capacity, and long-term...Permanent employmentFull timeWork at officeWork from home$160k - $195k
...follow us on X, LinkedIn and Facebook.Role Summary:The Associate Director, Quality Management Systems is a key member of the quality team responsible... ...management and training ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory...Local area$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 week... ...Development (MPD) with the overall goal of inspection readiness. Serves as a Strategic Quality Thought Partner to...Temporary workFor contractorsWork at officeImmediate startNight shift2 days per week- Alnylam Pharmaceuticals seeks an Associate Director of Digital Quality Compliance to own and advance Quality digital capabilities. You will oversee... ...lead cross-functional governance forums to enable inspection readiness and continuous #J-18808-Ljbffr Alnylam...
- ...Responsibilities: The Associate Director, Regulatory Affairs CMC will be responsible for... ...documents for submission-readiness, to ensure that all... ...guidelines. Ensures high-quality and on-time submissions,... .... Support regulatory inspections and audits Navigate the...
- ...Job Description Job Description Description: The Director/Associate Director, Quality Management Systems, reporting directly to the Senior Director... ...responsibilities. Ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory expectations...Work experience placementWork at officeRemote workNight shift
$155k - $214k
About This Role:As the Associate Director, Global Quality Risk Management, you will be at the forefront of Biogen’s commitment to quality excellence... ...forums.Prepare materials for health authority inspections and external audits pertaining to risk-based decisions....Full timeTemporary workLocal area$190k - $230k
...Job Description Job Description Associate Director/Director, Technical Quality – Solid Biosciences Charlestown, MA or Remote (US) Solid Biosciences... ...into actions required for improvement. Act as an inspection lead and/or liaison for regulatory inspections...Temporary workRemote workFlexible hours$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... ...preclinical, clinical, and CMC processes, with...Full timeContract workWork experience placementSummer workRemote workFlexible hours2 days per week$142.5k - $256.5k
...industry.Reporting to the Director, Regulatory... ...Management (RIM), the Associate Director, Regulatory... ...Regulatory Operations, CMC, Labeling, Quality, Enterprise Data,... ...capabilities.Lead business readiness activities... ...data integrity and inspection readiness.Serve as the...Permanent employmentFull timeFor contractorsWork at officeWork from home$153.6k - $241.34k
Associate Director, Clinical & Quality Process Compliance Location: Cambridge, MA - Hybrid (not remote). Relocation benefit available. Job Description... ...audit program, hosting or leading regulatory inspections, investigations, and remediation activities on a global...Temporary workLocal areaRelocation package- ...Position Summary The Associate Director, Medical Safety is responsible... ...Biostatistics, and Manufacturing/Quality. Responsibilities... ...coordination with Clinical and CMC/Manufacturing teams... ...UPESI handling Support inspection readiness and participate in internal...Full timeWork at officeRemote work
$136.51k - $204.77k
...Job Title: Associate Director, CMC Lead Introduction to role: Are you ready to lead early-stage CMC strategy that turns precision radioconjugate science into... ...strategy; guide and contribute to authoring high-quality documentation and data packages for IND/IMPD submissions...Hourly payTemporary work$155.4k - $233k
## Program Quality Associate Director, AssuranceApplylocations: Boston, MAtime type: Full timeposted on: Posted Todaytime... ...closure of CAPAs* Support organizational readiness for internal, external, and regulatory inspections or assessments* Collaborate with the Director...Summer 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... ...alignment with current regulatory expectationsDrive Quality readiness for major development milestones including IND/IMPD...Full timeContract workSummer workRemote workFlexible hours2 days per week- Responsibilities: Define and execute the IT solutions roadmap for CMC digital transformation. Oversee implementation and lifecycle... ...Ensure GxP/data integrity/global regulatory compliance and audit readiness. Drive operational excellence for CMC systems (e.g., Empower, SoftMax...Flexible hours
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