Senior Director, R&D QA & Regulatory Compliance
Jobleads-US
Akebia Therapeutics, Inc. in Waltham, Massachusetts, seeks a Sr.
Director, Research and Development Quality Assurance to lead day-to-day GCP/GLP/GVP quality operations, set strategy, budgeting, and team development across non-clinical and clinical trials from first-in-human through commercial authorization. The role involves collaboration with Clinical Development, Clinical Operations, Statistics & Data Management, and Regulatory, ensuring regulatory alignment and high-quality execution, with
#J-18808-Ljbffr Jobleads-US$258.33k - $280k
...Leadership: Manage the lifecycle of GxP systems across QA, Clinical Ops, CMC, and Research, ensuring full compliance with 21 CFR Part 11 and modern industry standards.... ...: Support scientific teams (PD, analytical, R&D) by ensuring vendor and data integrity for BLA-enabling...SeniorRemote work3 days per week$200k - $250k
...Summary: Nova Biomedical is seeking a Senior Director, Global Portfolio Management –... ...between customer needs, product strategy, R&D priorities, and business value. Partner... ...Marketing, Applications, Operations, Quality, Regulatory, and Finance teams. ~ Demonstrated...SeniorHourly payWork at officeFlexible hours- ...destiny. Build the people strategy behind Klaviyo's AI-first R&D engine. Klaviyo is becoming an AI-first company - not as... ...building something that lasts. Someone who's comfortable challenging a senior leader on org design at 9am and coaching a first-time people...SeniorFull timeShift work
$210k - $300k
The Senior Director, Integrated Solutions Execution & Offerings, leads a team of enterprise-level... ...our Leadership Behaviors—Integrity & Compliance, Customer Focus, Collaboration, Courage... ...gaps into actionable input for R&D and Product Management to advance Repligen...SeniorWorldwideFlexible hours$77k - $202k
...SummaryThe Opportunity As a Pharma and Life Sciences R&D Operations Consultant, Senior Associate, you will engage with clients to advise on... ...operations, organizational design, process optimization, regulatory compliance, decision support, and analytics. You will leverage...SeniorFull timeContract workH1b- ...innovation capability, and we're looking for a Senior Director of Search & Evaluation to help shape... ...onsite (3 days a week) at one of our R&D hub sites: Zurich (CH), Maidenhead (UK)... ...-stage assets, coordinating clinical, regulatory, commercial, and market access...SeniorRemote work3 days per week
$233k - $285k
...and Facebook.Role Summary:The Senior Director, FP&A serves as a strategic finance... ...modeling processes across R&D functions: Research, Clinical Development, Regulatory and Portfolio Strategy &... ...to detail, and commitment to compliance, confidentiality, and financial...SeniorWork at officeLocal area$231.99k - $347.98k
...Position : Senior Director, Head of Rare Neurology Thought Leader Liaisons Location : Boston, MA (US Headquarters... ...closely with marketing operations, legal, and compliance to ensure regional programs meet all regulatory and company standards. Congress Strategy &...SeniorTemporary workLocal areaNight shift3 days per week$206.25k - $297.92k
Job title: Senior Director Type 2 ImmunologyLocation: Cambridge, MAAbout the jobWe have an exciting... ...meets bold, AI-powered research. In R&D, you’ll drive breakthroughs that could... ....Partner with Clinical Development and Regulatory Affairs to translate preclinical...SeniorFull time$250k - $290k
...follow us on X, LinkedIn and Facebook. Role Summary The Senior Director, Biostatistics provides strategic, technical, and... ...clinical trial results, and preparation of clinical study reports, regulatory documents, manuscripts, and scientific presentations. The Senior...SeniorInterim roleLocal area- ...Senior Director Oncology Small Molecules And Targeted Delivery Pathology Therapeutic Area Lead... ...Development team in Biopharmaceuticals R&D as a Senior Director, Oncology Small Molecules... ...industrial partners, competitors, and regulatory agencies. Essential Skills/...SeniorWork at officeFlexible hours3 days per week
- ...Veeva Systems, Inc. is seeking a Principal Consultant in R&D to help customers accelerate patient access by transforming how they... ...programs across Clinical Operations, Clinical Data Management, Regulatory, or Pharmacovigilance, building credibility and thought leadership...Senior
- ...Repligen seeks a Senior Director, Integrated Solutions Execution & Offerings to lead a team of enterprise-level experts responsible for solution architecture, proposal development, and end-to-end project execution, reporting to the Vice President, Integrated Solutions....Senior
- ...position AbbVie as a global leader, championing those standards for both internal and external innovation and from study teams to senior leadership. Leads or supports with discovery and development leaders the scientific pursuits of precision medicine in psychiatry...SeniorFull timeWork experience placementLocal area
- ...Repligen Corporation seeks a Senior Director to lead Integrated Solutions Execution & Offerings. You will guide architecture, proposal development, and end-to-end project execution, coordinating with Product Management, Manufacturing, Quality, and Finance to deliver complex...Senior
$274.82k - $293.88k
...Senior Director, Biostatistics In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting... ...input into clinical development plans, and familiarity with regulatory standards and requirements. Alkermes has recently adopted...SeniorWork at officeLocal areaFlexible hours3 days per week$274.82k - $293.88k
...In this position, the Senior Director, Biostatistics will work with a team of statisticians supporting drug development activities and... ...input into clinical development plans, and familiarity with regulatory standards and requirements.Alkermes has recently adopted a hybrid...SeniorWork at officeLocal areaFlexible hours3 days per week$235k - $295k
...strategic input and quantitative expertise to shape the clinical development plan. Collaborate with senior leaders in Medical, Clinical Research, and Regulatory Affairs to address critical questions and support data-driven clinical decision-making. Represent the...SeniorFull timeWork at officeImmediate startRemote workWork from homeFlexible hours3 days per week- ...research & development, R&D Quality Assurance... ...innovation, regulatory landscape, and AbbVie... ...regulatory compliance, and contributes to... ...development programs. Senior Manager, Safety,... ...Affairs (MA) QA team which provides... ...role reports to the Director Safety, Medical &...SeniorFull timeLocal areaWorldwide
- ...Join to apply for the Senior Director, Biostatistics role at BioSpace 22 hours ago Be among the... ..., leading statistics efforts during regulatory submissions, serving as the primary statistics... ...,100.00 1 week ago Associate Director, R&D Data Science and Digital Health -...SeniorFull timeLocal areaRemote work
$192.7k - $289k
...With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. Senior Director, IT M&A Integration The IT Mergers & Acquisitions (M&A) team...SeniorFull timeTemporary workWork at office$165k - $195k
...on LinkedIn. About the Role: The Director / Senior Director, Science plays an integral role... ...external stakeholders and internal R&D/product teams. Cross-Functional Product... ...Work closely with product, clinical, and regulatory teams to ensure that product...SeniorPermanent employmentTemporary workWork at officeLocal areaRemote workVisa sponsorshipFlexible hours- Quotient Therapeutics is seeking a Senior Director of Business Development to lead partnering, asset in-licensing, and market intelligence... ..., manage end-to-end deals, and collaborate across R&D, clinical, regulatory, and executive teams in a fast-paced, early-stage setting...Senior
$150k - $176k
...LinkedIn. Position Overview: The Senior Manager, CMC Technical Writing will author... ...programs. Reporting to the Sr. Director, Product Development, this individual will... ...closely with internal technical functions, Regulatory Affairs, Quality, and external partners...SeniorContract workLocal area$180k - $220k
...that they do. We’re characterized by both technical excellence and next-level collaboration and respect.The RoleTutor is hiring a Senior Technical Program Manager to own program management for the Cassie workstream. Cassie is our robot worker for pallets and cases: we...SeniorFull timeWork at office$261k - $319k
...OVERVIEW Disc Medicine is seeking an experienced, strategic Senior Director, Toxicology to join our team. Reporting directly to the Vice... ...data interpretation and strategy. Knowledge of nonclinical regulatory frameworks and ability to draft relevant toxicology sections...SeniorRemote workFlexible hours- ...Booz Allen Hamilton seeks a Technical Program Senior Manager to design, implement, and maintain strategic, multi-disciplinary IT programs in support of corporate strategy. You will apply leading-edge principles and mentor employees while solving unusually complex problems...Senior
$166k - $220k
..., we’re not just changing the game – we’re redefining it. As a Senior People Business Partner, you will collaborate with leadership and... ...various HR/People channels, including compensation & benefits, compliance, employee relations, and learning and development. Proven...SeniorHourly payFull timeWork experience placementRelocation package$86.6k - $122.9k
...steps to upload your application.YOUR MISSIONThe Senior HR Business Partner reports to the Senior Director HR and serves as a strategic partner and end‑to‑end... ...in partnership with external legal counsel.Ensure compliance with HR-related federal, state, local and company...SeniorPermanent employmentFull timeLocal areaWorldwide$130k - $145k
...continues to grow across the Boston market, the Senior HR Business Partner will serve as the... ...-matter expert on employee relations, compliance, and risk mitigation. This role combines... ...labor risk. 3. Labor Compliance & Regulatory Readiness Serve as Tatte's regional...SeniorFull timeLocal areaFlexible hoursShift work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Director, R&D QA & Regulatory Compliance. Be the first to apply!
- manager regulatory affairs Waltham, MA
- head compliance Waltham, MA
- compliance manager Waltham, MA
- regulatory affairs director Waltham, MA
- director global regulatory affairs Waltham, MA
- compliance director Waltham, MA
- regulatory & compliance manager Waltham, MA
- regulatory manager Waltham, MA
- senior software engineer ruby on rails Waltham, MA
- senior customer service Waltham, MA




