Global CMC Quality & Compliance Director
Jobleads-US
Vertex is seeking a CMC Quality Compliance Director to lead inspection readiness and compliance across GMP sites, including external CMOs and internal manufacturing. You will drive risk-based governance and strategic improvements to quality systems.
The role requires a Bachelor's in science and approximately 10 years of experience with 3 years in management, plus hybrid/on-site flexibility to advance quality culture across the organization.
#J-18808-Ljbffr Jobleads-US$184.6k - $277k
Job DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for inspection readiness and compliance of internal and external... ...for improvements.Knowledge and Skills:Expert knowledge of global GMP requirements and experience across multiple GxP...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$147.5k - $221.3k
Job DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is responsible for inspection readiness and... ...changed at any time. #LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific...SuggestedFull timeSummer workRemote workFlexible hours2 days per week- Treeline in Watertown, MA seeks a Head of Quality Assurance to provide strategic and operational... ...QMS and governance, collaborate with CMC, Regulatory, Clinical Operations, and Supply Chain, and ensure compliance with global regulations to protect patient safety and data...Suggested
- Biogen is seeking a Head of Global Product Quality for Biologics to lead a dynamic PDQ team, ensuring quality across the biologics portfolio. This... ...oversight, and cross-functional collaboration with CMC teams to drive quality excellence and continuous improvement...Suggested
$184.6k - $277k
...Vertex Pharmaceuticals seeks a Director of CMC Quality Compliance to lead inspection readiness and compliance programs across internal and external... ...management or leadership experience ~ Expert knowledge of global GMP requirements and multiple GxP areas ~ Strong...SuggestedWork experience placement$177k - $278.08k
...worldwide.This role is within the Global Regulatory Affairs (GRA)... ...Chemistry Manufacturing & Controls (CMC) and Devices organization, and... ...success and regulatory compliance. Ability to draw from prior experience... ...Development, Production, Quality Assurance can be considered. Strong...Minimum wageLocal areaRemote workWorldwide$147.5k - $221.3k
...Pharmaceuticals seeks an Associate Director to lead inspection readiness and compliance programs for external... ...to evaluate quality compliance, drive continuous... ...~8+ years of relevant CMC quality or compliance experience... ...~ Knowledge of global regulatory requirements...$186.23k - $279.35k
...teams. Apply knowledge of current local and global Regulatory trends to identifyfuture... .../project· Ensures all markets remain in compliance with product licences maintained and ensuring... ...have an appropriate knowledge of quality and compliance· Has personal responsibility...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead provides executive leadership and independent quality oversight of Alnylam... ..., operational excellence, and long-term regulatory compliance.This role can be based in Cambridge, MA or Philadelphia...Full timeTemporary workLocal areaRemote workFlexible hours- Sarepta Therapeutics is seeking a Director, Corporate Quality to lead GCP/GLP QA across Clinical Development and Real-World Evidence. You will ensure FDA/ICH compliance and partner with Clinical, Pharmacovigilance, and Research teams to uphold patient safety and scientific...
- ...member of the GVP QA team providing Quality oversight of the global post-marketing pharmacovigilance system... ....This position reports to the Director, Global PV Quality Assurance and frequently... ...system, including ensuring compliance with GVP regulations. This includes...Work experience placementRemote workWorldwide
- Takeda in Boston, MA is seeking a Director Regulatory Site CMC to lead site-specific post-approval change management and regulatory submissions across... .... This role requires 10+ years in biopharma with deep global HA regulatory experience, an advanced scientific degree,...
$142.5k - $256.5k
The Role:The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products, depending... ...teams and will be responsible for preparation of CMC and Quality related agency correspondence and regulatory applications...Permanent employmentFull timeWork at officeWork from home$142.5k - $256.5k
...RoleModerna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...preparing and overseeing CMC and Quality related agency correspondence and regulatory... ..., and providing regulatory compliance support for the development of global...Permanent employmentFull timeWork at officeWork from home$184k - $253k
About This Role: As the Head of Global Product Quality for Biologics, you will lead a dynamic team... ...activities between business partners, the CMC Asset Team, and the Quality... ...position not only guarantees quality compliance but also develops the capabilities of...Temporary workWork at officeLocal area$250k - $273k
...who need it most.We're seeking a Senior Director, Quality Compliance reporting to the VP, Head of Quality,... ...and oversight of the organization’s global quality compliance programs, ensuring... ...across multiple regions.Collaborate with CMC, Regulatory Affairs, Clinical,...Work at office- ...Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You... ...small molecule programs, develop global submission plans, and coordinate... ...supervision, driving high-quality submissions and robust compliance. #J-18808-Ljbffr Relay...
- ...seeking a Head of Regulatory Affairs to lead global regulatory strategy across the full product lifecycle. You will ensure compliance with domestic and international... ...s expansion while maintaining high safety, quality, and compliance standards. #J-18808-Ljbffr...
$200k - $265k
...create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement... ...activities and documents, including clinical, non-clinical, and CMC development documentation as neededQualificationsKnowledge and...Full timeTemporary workWork experience placementWork at officeWorldwide- Take the lead in shaping global pharmacovigilance quality excellence, overseeing critical audit programmes, vendor quality, and regulatory compliance activities. R&D Partners is seeking a Senior Manager, Global Pharmacovigilance (PV) Quality Assurance to provide quality...
$180k - $245k
...experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts... ...background is preferred. CMC experience is a plus.ResponsibilitiesDevelop... ...major agencies.Ensure compliance with global regulatory... ...to ensure high-quality submissions, and...$215k - $235k
...people embrace these qualities, so if this sounds like... ...on!About the Role:The Director of Regulatory Affairs... ...this role serves as the Global Regulatory Lead on... ...clinical, nonclinical, and CMC development plans.... ...quality, consistency, and compliance.Cross Functional &...$241k - $332k
...Role:As the Head of Regulatory CMC - Biologics & Advanced Therapy... .... Your role encompasses global, regional, and local accountability... ...submission readiness and regulatory compliance across all phases of... ...coordinating with Technical Operations, Quality, and Supply Chain.Participate...Full timeTemporary workLocal area$210k - $320k
...Position Overview: The Regulatory Director/Sr. Director Regulatory CMC will be responsible for preparing CMC and Quality related health authority agency... ...govern CMC submissions and regulatory compliance support for the development of global products. This position will lead...Full timeShift work3 days per week1 day per week- ...Description: This role is within the Global Regulatory Affairs (GRA)... ...Manufacturing & Controls (CMC) and Devices organization, and... ...regulatory success and regulatory compliance. Ability to draw from... ...Analytical Development, Production, Quality Assurance can be considered. Understanding...
$195k - $330k
...Lead the development and execution of global regulatory CMC strategies for degrader programs across... ..., partnering closely with CMC, Quality, Non-Clinical, and Clinical Development... ...testing partners to ensure regulatory compliance and submission readiness.Scale and lead...$142.5k - $256.5k
...Moderna is looking for an Associate Director, Global Regulatory Affairs, CMC, to join our team. This pivotal... ...on preparing and overseeing CMC and Quality related agency correspondence and regulatory... ..., and providing regulatory compliance support for the development of global...Permanent employmentWork at officeLocal areaWork from home- ...Vertex is seeking an Associate Director, CMC Quality Compliance and Inspection Readiness to lead inspection readiness programs across external sites, drive continuous improvement, and partner across functions to sustain regulatory compliance and a strong quality culture...
- Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications. The role sits within Regulatory and partners with cross-functional teams to shape strategies for...3 days per week1 day per week
$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for-purpose... ...-appropriate Quality oversight of CMC and analytical strategies, including... ...integrity, computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements...Contract workFor contractorsShift work
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