CMC Quality & Inspection Readiness Lead
Vertex Pharmaceuticals
Vertex Pharmaceuticals is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to drive inspection readiness and compliance for external sites. The role collaborates across functions and sites to maintain quality culture and address risks through audits and CAPA closures. The position demands deep regulatory knowledge, experience with multiple modalities, and proven leadership in quality improvement projects, enabling continuous operational excellence in a global #J-18808-Ljbffr Vertex Pharmaceuticals
- Vertex Pharmaceuticals seeks a CMC Quality Compliance Director to lead inspection readiness and compliance for internal and external GMP sites. You will drive governance, risk-based strategies, and a high-quality culture across manufacturing and testing operations in support...Quality
- Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and... ...experience such as six sigma or leanProven ability to lead improvement projects and project teams and organize various...QualityFull 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 external operations, collaborate across functions, and guide risk assessments and CAPA closures to sustain...QualityRemote work
- Vertex Pharmaceuticals Inc. seeks an Associate Director, CMC Quality Compliance and Inspection Readiness in Boston. You will own inspection readiness for... ...drive continuous improvement of quality programs, and lead cross-functional teams to address risks and CAPAs. The...Quality
- Vertex Pharmaceuticals Inc. seeks a CMC Quality Compliance Director to oversee inspection readiness and comprehensive quality compliance across internal and external... ...in quality culture. Responsibilities include leading cross-functional teams, monitoring regulatory trends...Quality
$148.5k - $214.5k
...Job title CMC dossier leader Location : Framingham... ...About the job Are you ready to shape the future of... ...and responsibilities in leading the preparation of CMC... ...meetings with agency, site inspections, or written responses... .... Knowledge of digital quality management systems and...Quality- 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...Quality
- Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external sites including evaluating... .../influencing skills with proven ability to lead teamsEducation and Experience:Bachelor's degree...QualityFull timeWork experience placementSummer workRemote workFlexible hours2 days per week
$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... ...strategy; guide and contribute to authoring high-quality documentation and data packages for IND/IMPD submissions...QualityHourly payTemporary work$151.2k - $226.8k
...document control, training, and quality records support consistent... ...are complete, traceable, audit-ready, and meet data integrity... ...overdue items, training compliance)Lead QMS simplification/... ...environmentsExperience supporting QMS-related inspections and audits QMS design,...Quality$136.4k - $253.2k
...Analytical Data Science is recognized as a leading hub for top industry talent, operating... ..., ensuring the delivery of high-quality, regulatory-compliant analytical outputs... ...the TA leadYou ensure compliance and inspection readiness by establishing robust quality review...QualityFull timeLocal area$170k - $240k
...wall-climbing robots, industry-leading sensors, and an AI-powered... ...operations, promote mission readiness, and protect the environment... ...defense assets faster, at a higher quality, and with a digitally-native... ...Understanding of structural inspection, corrosion, or lifecycle...QualityPermanent employmentFull timeWork at officeLocal areaWork from homeFlexible hours$103.45k - $169.96k
As the Organization Readiness Program Lead, you will execute on and support the Group Benefits Underwriting Transformation strategy. You will... ...autonomously and organize your work so the business can achieve high quality, repeatable, consistent results.Establish and maintain...QualityFull timeWork experience placementH1bWork at officeRemote workVisa sponsorshipWork visaFlexible hours3 days per week$144.5k - $195.5k
The Global Study Lead (Sr. Manager, Clinical Operations) is responsible... ..., and delivers high-quality trial execution in support of... ...conduct of, Health Authority Inspections and internal QA auditsEnsure... ...constant state of inspection-readiness, collaborating with R&D Quality...QualityFull timeTemporary workLocal areaRemote workFlexible hours- Kymera Therapeutics is seeking a Quality Systems professional to manage the operational infrastructure of the QMS, including document... ...training curricula, track QMS metrics, and support readiness for inspections as Kymera advances late-stage development and #J-18808-Ljbffr...Quality
- ...Therapeutics, Inc. is seeking an Associate Director, Regulatory Affairs CMC to lead regulatory CMC efforts for a portfolio of gene-based medicines... ...Affairs, you will manage complex CMC topics, prepare high-quality submissions, and guide global teams through INDs, CTAs, #J-18...QualityContract workWorldwide
$151.2k - $226.8k
...document control, training, and quality records support consistent... ...are complete, traceable, audit-ready, and meet data integrity... ...items, training compliance) Lead QMS simplification/optimization... ...Experience supporting QMS‑related inspections and audits QMS design,...QualityContract workFor contractorsFor subcontractorWork at officeVisa sponsorshipFlexible hours$103.45k - $169.96k
Position Overview As the Organization Readiness Program Lead, you will execute on and support the Group Benefits Underwriting Transformation... ...autonomously and organize your work so the business can achieve high quality, repeatable, consistent results. Establish and maintain...QualityFull timeWork experience placementH1bWork at officeRemote workFlexible hours3 days per week$202.5k - $337.5k
Global CMC Automation and Robotics Leader 2 weeks ago Be among the... ..., MA About The Job Are you ready to shape the future of medicine... ...robots across CMC Build and lead a team of advanced automation... ...wellbeing benefits including high‑quality healthcare, prevention and...QualityFull timeLocal area- Beeline Medicines seeks a Senior Director, Regulatory Affairs CMC - Biologics to lead regulatory science for biologics assets, including... ...collaborate with Process Development, Analytical Sciences, Quality, and external CMOs to align with FDA/EMA expectations and global...Quality
- Rhythm Pharmaceuticals Inc. in Boston, MA seeks an experienced Regulatory CMC professional to drive high-quality regulatory chemistry, manufacturing, and controls deliverables. You will support global filing strategies, coordinate with Global Regulatory Affairs, Technical...Quality
- Moderna, based in Cambridge, MA, seeks a Regulatory Inspection Lead to plan and coordinate regulatory authority inspections (FDA, EMA) across... ..., and track CAPAs to closure, contributing to an inspection-ready culture. You will lead trainings, mock inspections, and development...
- ...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...Quality
- ...Medicines Corporation is seeking a Senior Director, GCP Quality Assurance to lead strategic and operational GCP QA across clinical... ...regulatory requirements and company policies while maintaining inspection readiness. As a senior partner to Clinical Operations, Regulatory...Quality
$177k - $278.08k
...(GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute... ...: You will be the GRA CMC Franchise Lead for TAK-079 Independently develops the regulatory... ..., Analytical Development, Production, Quality Assurance can be considered. Strong...QualityMinimum wageFull timeTemporary workLocal areaRemote workWorldwide$163k - $225k
...Operations and Technology (PO&T) Division is looking to hire a CMC Asset Lead. This Associate Director level Asset Lead is a member of the... ...from process/analytical development, manufacturing, quality, supply chain, device (if applicable) and regulatory CMC, in...QualityFull timeTemporary workLocal area- Vertex Pharmaceuticals seeks a CMC Statistics Director (Scientific Fellow) to lead statistical sciences across the product lifecycle, partnering with Development, MSAT, Quality, Regulatory Affairs, and Data & Digital teams to drive data-driven decisions and improve product...Quality
- ...seeking an Associate Director, Quality Operations to provide end-to-... ...manufacturing processes. You will lead QA activities across... ...involves authoring and reviewing IND CMC submissions, managing quality... ...systems, supporting regulatory inspections, and collaborating with...QualityRemote job
$144k - $195k
...radical care. The Associate Director, Quality Compliance is a key member of the QA Compliance... ...validation activities. This role also leads regulatory impact assessments, annual... ...vendors to support health authority inspection readiness activities, mock inspections and...QualityFull timeWork at officeFlexible hours3 days per week$99.2k - $134.68k
...employees and visitorsEnsure daily facilities inspections are conducted and documented, confirming... ...verifying that completed services meet quality standards and compliance requirements.... ...with department and senior leaders; lead and project manage office renovations, installations...QualityFull timeContract workFor contractorsWork at officeLocal areaWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to CMC Quality & Inspection Readiness Lead. Be the first to apply!
- quality lead Boston, MA
- water quality scientist Boston, MA
- quality management nurse Boston, MA
- quality manufacturing Boston, MA
- vice president of quality Boston, MA
- quality equipment Boston, MA
- quality improvement nurse Boston, MA
- rn quality Boston, MA
- supplier quality Boston, MA
- quality assurance quality control engineer Boston, MA


