Global QA Director: Strategy, Compliance & Audit
Jobleads-US
Emmes Group, a premier clinical research organization, seeks a Senior Director, Quality Assurance to lead the global QA program and support the VP of Quality & Compliance. You will guide strategy, audits, and continuous improvement across worldwide trials, ensuring regulatory readiness and strong QMS governance.
You will manage a global QA team, drive inspection readiness, and partner with stakeholders to uphold quality and safety in all trials.
#J-18808-Ljbffr Jobleads-US- ...AstraZeneca is seeking a Director of Regulatory Affairs Strategy for cell therapy in the United States. The role focuses on shaping global regulatory strategy for CGT programs spanning oncology and immune-mediated diseases, translating breakthrough science into timely...Suggested
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- The Emmes Group aims to hire a Sr. Director, Quality Assurance to lead global clinical QA strategy and a worldwide QA team. This role reports to the VP, Quality & Compliance and drives inspection readiness, metrics, CAPA management, and QMS improvement across the organization...SuggestedRemote jobWorldwide
- ...AstraZeneca plc in Gaithersburg is seeking a Senior Director for Global Regulatory Digital Strategy. You will lead the development and implementation of a comprehensive digital strategy across Regulatory, working with IT, AI units and external partners to ensure delivery...Suggested
$186.23k - $279.35k
Job Title: Director, Regulatory Affairs Strategy - Cell Therapy Available locations: Gaithersburg, MDBoston, MASouth San Francisco, CASanta Monica, CAIntroduction to role: Are you ready to steer global regulatory strategy for cell therapies that redefine standards of care...Hourly payFull timeTemporary workWork at officeLocal areaFlexible hours3 days per week- ...CRB is seeking a Director, Oligo & Peptide Market Segment Leader to drive long-term global growth in the life sciences facility sector. You will lead a cross-functional team, shape strategy, and expand CRB’s presence in oligo and peptides markets worldwide. This role...Worldwide
$208.06k - $262.15k
...commitment to fairness, integrity, and global collaboration. This belief is embedded in... ...developing and implementing a global growth strategy for USP’sexternally fundedregulatory and... ..., the followingdirect reports:Director / Sr Manager, International regulatory and...Full timeWork experience placementWork at officeWorldwide- Role Senior leader responsible for global Market Access, HTA, pricing, and evidence generation strategies for oncology products, focusing on KIMMTRAK (tebentafusp). Responsibilities develop and lead RWE and HEOR strategies across 40+ countries collaborate with Commercial...
- The Director will be a core strategic leader and member of the global Market Access team responsible for shaping and executing... ...pricing, and evidence generation strategies, encompassing Real World... ...Legal and Procurement to ensure compliance and invoice reconciliation for...Local areaFlexible hours
- AstraZeneca seeks a Regulatory Affairs Director to shape US regulatory strategy for oncology therapies, accelerating innovation and patient access. You... ...development, submission, approval and lifecycle management in a global matrix environment. You will drive major submissions (...
- ...seeking a Manager, Regulatory Affairs to lead regulatory strategy and biosafety-compliance for diverse clinical programs. This remote US role combines... ..., mentor a regulatory team, and ensure on-time, audit-ready deliverables while coordinating with cross-functional...Remote job
- ...AstraZeneca GmbH seeks a Strategy and Commercial Executive Director for Cell Therapy Strategy and Commercial (CTSC). You will shape end-to-end strategy for a therapeutic indication, lead global commercial initiatives, and align with clinical, data science, and market...
$196.7k - $353.4k
The Role:Moderna, Inc. is seeking a Sr. Director of Regulatory Strategy to lead Regulatory Strategy programs to be based in its Cambridge headquarters... ...disease vaccines as unprecedented new drug modality globally. The Sr. Director will be a strategic leader within Global...Permanent employmentFull timeWork at officeWork from home- GlaxoSmithKline is seeking a Global Regulatory Affairs Manager in Rockville, MD, to lead global/regional regulatory strategies for oncology assets and ensure timely labeling and approvals. You will partner with GRL and TA Head, driving regulatory interactions across regions...
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Global Regulatory Affairs Manager, Oncology We create a place where people can grow, be... ...execute global and regional regulatory strategies for oncology assets, ensuring optimal labeling and approvals while maintaining compliance with internal and external requirements....Work at officeLocal areaRemote work- ...role. The position is hybrid with onsite Tue-Thu. You will author and coordinate CMC submissions, manage regulatory strategy, and collaborate with global teams and CMOs/CROs. The ideal candidate has a Master’s or PhD with extensive regulatory experience in commercial products...
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...Job Title: Senior Director Global Regulatory, Digital Location: Gaithersburg At AstraZeneca... ...Director, Global Regulatory Digital Strategy is accountable for the development and... ...and make data-driven decisions. ~ Compliance: Ensure all digital initiatives are compliant...Hourly payTemporary workWork at officeWorldwide3 days per week- ...deliver? Accountabilities: Vision and Strategy: Define a multi-year AI/digital acceleration... ...targets, and an investment roadmap. Global Standards and Transformation: Set... ...and lifecycle management with strong compliance and audit outcomes. Change Leadership and Ways of...Hourly payFull timeContract workTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week
- ...work and build a career, KPMG provides audit, tax and advisory services for... ...our team.KPMG is currently seeking a Director, Corporate Strategy to join our Corporate Strategy organization... ...further information regarding KPMG's compliance with federal, state and local...H1bLocal areaShift work
- Immunocore seeks a Director of Regulatory Affairs to lead global regulatory strategy across development programs, including IND/CTA, BLA/MAA submissions, and FDA interactions. This role oversees US and international submissions and coordinates with global sites to ensure...Remote job
$189.5k - $235k
Vacancy Name Director, Regulatory Affairs-Global Regulatory Lead Vacancy No VN723 Employment Type Full Time... ...Regulatory scientific and tactical strategy development, IND development/... ...and CMC submissions for regulatory compliance, in conjunction with the Director of...Full timeWork at officeLocal areaRemote workWorldwideNight shift$206.99k - $310.49k
...from Boston, MA will also be considered Global Portfolio & Project Management (GPPM)... ...average 3 days/week in office The Senior Director, OncologyGlobal Project Management is a... ...brand strategy and deliverthe approved project plans....Temporary workWork at officeFlexible hoursShift work3 days per week- Scorpion Therapeutics is seeking a Director of Regulatory CMC for Cell Therapy to lead global regulatory strategy and submissions across development and lifecycle stages. The role focuses on cell therapy programs, with emphasis on advanced therapies and biologics, requiring...
$267.91k - $401.87k
...collaboration with AstraZeneca’s Therapeutic Area Units. The Strategy and Commercial Executive Director Cell Therapy Strategy and Commercial (CTSC), is a... ...or disease area within Cell Therapy. You will lead global commercial and strategic initiatives within the Cell...Temporary workWork at officeFlexible hours3 days per week- ...impact at AstraZeneca by leading strategy for our industry-leading... ...eradicating cancer. As Executive Director, Oncology Business Unit (OBU)... ...with Oncology R&D and global franchise partners. Engage... ...portfolio reviews, business and audit reviews), including...Hourly payTemporary work
- ...AstraZeneca is seeking a Senior Director to lead Oncology Global Programme Management (Cell Therapy) in Gaithersburg, MD. This hybrid role requires steering global project teams, aligning with product, scientific, and clinical leaders to deliver strategic plans and portfolio...Work at office
$200.81k - $286.16k
...play a vital role in increasing global access to high-quality... ...environments.The Senior Technical Director, Global Manufacturing... ...alignment with approved program strategies and donor objectives.Oversee... ...meet high standards of quality, compliance, and relevance to global health...Full timeWork at officeWorldwide- AstraZeneca in Gaithersburg, MD seeks a Director Oncology Engagements and Above-Brand Strategy to identify, lead and direct external Oncology initiatives across... ...and tumor types. You will partner with US and Global Oncology teams, manage cross-functional workstreams,...
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