Global Quality Director - Compliance & Risk (cGMP)
Regulatory Jobs
uniQure is seeking a Director of Corporate Quality to oversee the global Quality Management System (QMS) and ensure adherence to global cGMP regulations. This role leads Quality Systems, training, risk management, and data integrity across the organization to support transformative gene therapy medicines. The Director will build a high-performing Quality organization, provide strategic vision for growth, and act as main contact for regulatory agencies during inspections and licensing.
#J-18808-Ljbffr- ...Pharmaceuticals, based in Lexington, MA, seeks a Senior Director of Quality Compliance to lead global quality programs onsite five days a week. The role... ...Clinical, and Manufacturing functions. You will drive risk-based strategies, evolve QMS platforms (Veeva/TrackWise...Suggested
$184.6k - $277k
...DescriptionGeneral Summary:The CMC Quality Compliance Director is responsible for... ...ensuring phase appropriate and risk-based compliance.Key Duties... ...sites. Monitor and interpret cGMP regulatory guidelines and trends... ...Skills:Expert knowledge of global GMP requirements and...SuggestedFull timeWork experience placementSummer workRemote workFlexible hours2 days per week$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... ...cross-functionally to drive a proactive, risk-based quality culture that supports...SuggestedWork at office- ...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...Suggested
- ...: . Job Description Senior Director, Regulatory & Quality Counsel, Global , reports to the VP, Regulatory &... ...medical device regulatory, quality, compliance, enforcement, and... ...leadership on complex regulatory risks, support interactions with FDA and...SuggestedAfternoon shiftEarly shift
$188k - $230k
...office.Position Summary: The Associate Director, Quality Auditing & Compliance is responsible for leading and executing the company’s risk-based internal Quality audit program to... ...applicable FDA regulations, ICH guidelines, global regulatory requirements, company...Full timeWork at officeFlexible hours2 days per week3 days per week$147.5k - $221.3k
...DescriptionGeneral Summary:The Associate Director, CMC Quality Compliance and Inspection Readiness, is... ...identification and resolution of issues, gaps and risks through collaboration with... ...HybridCompany InformationVertex is a global biotechnology company that invests in...Full timeSummer workRemote workFlexible hours2 days per week$186.23k - $279.35k
...knowledge of current local and global Regulatory trends to... ...are known· Ensures adequate risk assessments and mitigation plans... ...Ensures all markets remain in compliance with product licences maintained... ...an appropriate knowledge of quality and compliance· Has personal...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week$184.6k - $277k
...Vertex Pharmaceuticals seeks a Director of CMC Quality Compliance to lead inspection readiness and compliance... ...regulatory guidelines and integrate risk-based control strategies into quality... ...leadership experience ~ Expert knowledge of global GMP requirements and multiple GxP...Work experience placement$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. Leading the charge in designing, implementing, and sustaining the enterprise Quality Risk Management (QRM) capabilities,...Full timeTemporary workLocal area$227.9k - $308.3k
Overview:The Senior Director, Global Pharmacovigilance Quality Assurance Lead provides executive leadership and independent... ...independent oversight, governance, risk-based assurance, quality-system... ..., and long-term regulatory compliance.This role can be based in Cambridge...Full timeTemporary workLocal areaRemote workFlexible hours$147.5k - $221.3k
...Pharmaceuticals seeks an Associate Director to lead inspection readiness and compliance programs for external... ...to evaluate quality compliance, drive continuous... ...resolve quality gaps and risks through assessments and... ...experience ~ Knowledge of global regulatory requirements...- ...the GVP QA team providing Quality oversight of the global post-marketing pharmacovigilance... ...position reports to the Director, Global PV Quality... ...system, including ensuring compliance with GVP regulations. This... ...analyses and CAPAs. Apply risk-based thinking in determining...Work experience placementRemote workWorldwide
- ...Job Description Job Description Director of Quality & Compliance General Gelsight seeks an experienced and versatile Quality professional... ...and present product and system performance, trends, and risks to executive leadership, including KPIs and health metrics...
$214.14k - $261.72k
...to help further build and refine our global compliance program as we prepare for commercialization. Reporting to the VP Risk and Compliance, the Director Risk and Compliance Operations will... ...functional initiatives, improving data quality and process performance, and...Full timeWork at office- ...biopharmaceutical company pioneering RNA splicing therapies, seeks a GCP Quality Assurance leader in Watertown, MA. You will oversee GCP... ...while guiding Clinical Operations and QA teams. You will drive risk-based quality programs, coordinate CAPAs, support drug safety reviews...
- ...Millipore Corporation is seeking a Senior Director, Global Head of CMS Strategy, Quality & Operations to partner with CMS leadership and drive the integrated... ...lead a high-impact organization focused on quality, compliance, and efficient R&D execution. The role requires...
$116k - $182.27k
...DescriptionOBJECTIVES:Computerized Systems Quality Assurance (CS QA) Lead helps... ...the quality and regulatory compliance of computerized systems and... ...deliverables produced for global computerized system projects,... ...requiredProactively identify risks and issues. Drive...Minimum wageWork at officeLocal areaImmediate startRemote workNight shift- ...critical unmet need. As a global leader in myostatin biology... ...experienced and motivated Director of Global Quality Control to support... ...control strategy, compendial compliance, specification lifecycle management... ...knowledge of USP, EP, JP, cGMP, ICH, data integrity,...Contract work
- ...device company to seek a Vice President of Quality. The role will lead the Quality organization through commercialization and global expansion from Boston, MA, on-site. The... ...and strategy, oversee the QMS, and ensure compliance with FDA, ISO 13485, MDR, and MDSAP across...
- ...The Senior Manager Global Regulatory Affairs CMC - Biological &... ...with CSL's R&D, Manufacturing, Quality, Regulatory Affairs stakeholders... ...evolving CMC regulatory and compliance requirements for the assigned... ...change; Effectively handles risk; Can decide and act without...Local areaFlexible hours
$150k - $170k
...Description Nova Biomedical: One Global Brand. One Vision. Together... ...Job Summary: The Sr. Quality Control Manager is responsible... ...product quality, regulatory compliance, and operational excellence throughout... ...trends, emerging product risks, recurring defects, process...Hourly payWork at officeFlexible hoursShift work$183.1k - $305.2k
...Responsibilities Lead functional workstreams in quality event management and inspection readiness programs Serve as primary contact... ...years pharmaceutical industry experience Deep knowledge of global PV regulations, FDA CFR, and GVP modules Demonstrated...$240k - $285k
...and Facebook.Role Summary:The Senior Director, Quality Control leads the strategy and execution... ...management. This role ensures global GMP compliance, inspection readiness, and robust analytical... ...and facilitate clear, timely, and risk-based decisions.Technical and Operational...Contract workLocal area- Job Overview:As a Quality Manager - Quality Systems & Standards, you will lead the processes... ..., R&D, and Supply Chain teams, ensuring compliance with food safety regulations, customer... ..., Clamato and Core Hydration. Our global coffee business spans more than 100 markets...
$210k - $290k
The Role: The Senior Director, GMP Quality will build/support and maintain fit-for... ...and maintain a scalable, risk-based GxP Quality framework covering... ..., computerized systems compliance, and alignment with global regulatory expectations, cGMP requirements, quality agreements...Contract workFor contractorsShift work- ...Vertex Pharmaceuticals seeks a Director of Global Trade Compliance to lead the development and execution of trade compliance processes, systems, and regulatory activities across pharmaceutical supply chains. This role oversees customs operations, export controls, and duty...
- ...Stoke Therapeutics seeks a Director of Global Regulatory Affairs to develop and execute regulatory strategies for its RNA medicine portfolio... ...teams to align plans with business goals Identify regulatory risks and develop mitigation strategies for stakeholder education...
- ...in Cambridge, MA. About the role: Quality is how Lumafield earns trust — with the... ...cutting-edge technology and the rigorous compliance standards our customers demand. This can... ...insights to refine processes and mitigate risks. About you: An Experienced Quality...Full timeWork at officeFlexible hours
$240k - $305k
...preserves vision and quality of life. For... ...Summary The Executive Director, GCP Quality... ...establishing and advancing a risk-based, inspection-... ...that supports global clinical development and ensures compliance with applicable... ...working knowledge of cGMP and GVP...Temporary work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Quality Director - Compliance & Risk (cGMP). Be the first to apply!
- quality manager healthcare Lexington, MA
- quality manager aerospace Lexington, MA
- compliance director Lexington, MA
- compliance manager Lexington, MA
- manager regulatory affairs Lexington, MA
- regulatory & compliance manager Lexington, MA
- regulatory manager Lexington, MA
- regulatory affairs director Lexington, MA
- head compliance Lexington, MA
- quality Lexington, MA




