Associate Director, CMC Quality & Inspection Readiness
Vertex Pharmaceuticals Incorporated
Vertex Pharmaceuticals Incorporated is seeking an Associate Director to lead CMC Quality Compliance and Inspection Readiness. You will drive inspection readiness for external operations, collaborate across functions, and guide risk assessments and CAPA closures to sustain quality excellence. The role requires a scientific degree and 8+ years of experience, with travel up to 10–20% and a hybrid work arrangement allowing remote or on-site days. #J-18808-Ljbffr Vertex Pharmaceuticals Incorporated
- 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
- 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...Suggested
- 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
- ...seeking an experienced Senior Manager/Associate Director, Quality Control to lead Quality Control... ...quality control checks on the CMC sections of regulatory submissions... ...external laboratories, FDA/EMA inspections, and inspection readiness is preferred. Strong experience...SuggestedTemporary workWork at officeRemote work2 days per week
$160k - $180k
...every single day. If you’re ready to be part of a tenacious,... ...beyond About the Role As the Associate Director, GMP Quality , reporting to the Head of... ...functional teams such CMC, Regulatory and Supply Chain... ...necessary Support Pre-Approval Inspection readiness for NDA /...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...Contract workLocal areaRemote work$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- 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...Full timeWork experience placementSummer workRemote workFlexible hours2 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- 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- ...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
$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$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$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$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- ...The Associate Director of Regulatory Affairs CMC will be responsible for developing, implementing and advising on... ...global basis. During health authority inspections, the Associate Director of... ...President of Regulatory Affairs and Quality Assurance and is located in Cambridge...
- 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 leading... ...for submission-readiness, to ensure that all submissions... .... Ensures high-quality and on-time submissions,... ...goals. Support regulatory inspections and audits Navigate the...
- The Director/Associate Director, Quality Management Systems, reporting directly to the Senior Director, Head of Quality, will be responsible for... ...Management responsibilities. Ensuring these systems are inspection-ready, risk-based, and aligned with global regulatory...Work experience placementWork at officeNight 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$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$160k - $240k
...Opportunity Overview As an Associate Director, Device Development, you... ...of device strategy across CMC, regulatory, clinical, and... ...interaction challenges Quality, Risk & Regulatory Own Design... ...and ensure compliance and inspection readiness Serve as SME for design...Work at office$195k - $330k
...impact:Drive end-to-end CMC program management for... ...product, analytical, quality, regulatory, and... ...transfer, and commercial readiness activities for oral solid... ...CMC experience; Sr. Director level requires commensurate... .../GLP compliance, and inspection readiness.Proven...$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$140k - $210k
Associate Director, Regulatory Starting Material Description... ...the Vice President, CMC, this role will serve... ...commercial manufacturing readiness. This individual will... ...Regulatory Affairs, Quality, and external... ...expertise during regulatory inspections and audits related to...Full timeContract workFor contractorsFor subcontractorWork at office- ...Manager Clinical Trial (open to Associate Director level) About Draig... ..., regulatory, and internal quality standards. As a core member... ...regulatory, safety, biostats, CMC, commercial) to design and... ...quality, data integrity, and inspection readiness. Proven leadership and stakeholder...
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