- Endo International (St. Louis, MO)
- …Problem Solving, Building Effective Teams **RELATIONSHIP WITH OTHERS:** Reports to the Sr Director , Quality and Regulatory Affairs. Manages group of exempt ... work to bring the best treatments forward. Our shared values of Integrity & Quality , Innovation, Drive, Collaboration and Empathy guide our team and enable us to… more
- Insmed Incorporated (NJ)
- …and for the future of science, we're in. Are you?About the Role:The Associate Director , Regulatory Affairs, CMC will be responsible for reviewing the CMC post ... development program and life cycle management, and ensure they meet current regulatory standards, are of high quality , consistent, and complete.Establish product… more
- Insmed Incorporated (NJ)
- … submissionsProvide oversight for preparation and delivery of materials for regulatory agency meetingsPrepare and deliver high- quality presentations for both ... for the future of science, we're in. Are you?About the Role:The Global Regulatory Lead (GRL) will be responsible for formulating and implementing global … more
- Post Holdings Inc. (Lakeville, MN)
- …about pet nutrition and regulatory excellence? Join our team as the **Associate Director of Pet Food Regulatory Affairs** , where you'll lead a talented team ... R\&D, and Quality teams. + Support commercialization efforts by ensuring regulatory readiness from concept to shelf. + Educate internal teams on competitive… more
- BeOne Medicines (San Mateo, CA)
- **General** **Description:** The Director , Regulatory Affairs, Dx/CDx and Medical Devices will be responsible for leading a small team for developing and ... Device related regulatory agency communications, submissions, and approvals, with a quality focus to minimize cyclical review + Lead and mentor team members +… more
- Merck & Co. (Ames, IA)
- Job DescriptionDirector - Global Quality Auditing and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and ... Support and will direct the below aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform comprehensive… more
- Insmed Incorporated (NJ)
- …other, and for the future of science, we're in. Are you?About the Role:The Associate Director , Patient Services Quality & Process leads quality assurance and ... training, and data-driven optimization aligned with Insmed's strategic goals.The Associate Director , Patient Services Quality & Process is responsible for… more
- Merck & Co. (Durham, NC)
- Job DescriptionWe're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this ... manufacturing excellence from development through commercialization. You'll partner across Quality , Regulatory , Technical, and Supply Chain teams-coaching,… more
- Insmed Incorporated (NJ)
- …internal teams and external partners. The position is critical in shaping quality strategy, managing risk, and supporting regulatory readiness for complex, ... of science, we're in. Are you?About the Role:The Sr. Director CMC QA will lead QA CMC oversight for...biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems, regulatory requirements (21 CFR Parts… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality team based in Raritan, NJ. Role OverviewThe Head of Compliance will be ... responsible for providing quality oversight over the... organization to ensure harmonization, alignment and execution of regulatory guidelines across all manufacturing areas, supporting both clinical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Director , representing the Quality organization at senior levels. The Director plays a pivotal role in regulatory inspections, external audits, and high ... fostering s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs … more
- Novo Nordisk Inc. (Boulder, CO)
- …through testing and quality programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory requirements and ... us. Our R&D hub merges biotech speed and agility with large pharmaceutical company quality , resources, and stability, uniting the best of both worlds to develop new… more
- Novo Nordisk Inc. (Seattle, WA)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Formation Bio (New York, NY)
- …Partner with other CMC groups (analytical development, supply chain, etc) quality assurance, regulatory , clinical pharmacology and project management to ... and manage drug product vendors, for both development and manufacturing, ensuring high- quality deliverables and compliance with GMP and regulatory standards.… more
- Merck & Co. (Rahway, NJ)
- …sustained launch in alignment with the company's business goals, and quality and regulatory compliance.Essential Duties and Responsibilities:Program Leadership ... Job DescriptionThe Associate Director - Device Tech Transfer is a leadership role...with receiving sites, drug product partners,and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input… more
- Merck & Co. (Rahway, NJ)
- …will ensure products and processes are developed in accordance with applicable regulatory , quality , company, and customer requirements.-This position will lead ... Principal Scientist - Device Technical and Engineering Lead (Associate Director Equivalent) Our company's Device Product & Process Development (DPPD)… more
- Merck & Co. (Rahway, NJ)
- …with internal stakeholders, including supply chain, packaging commercialization, quality , analytical, regulatory , manufacturing, Device Development and ... Job DescriptionReporting into the Executive Director Packaging Technical Operations the Director ...drug product container closure systems including mold qualification and regulatory compliance.- To act as master data stewards and… more
- Insmed Incorporated (San Diego, CA)
- …will provide clinical and scientific support to clinical development and operations, regulatory , medical affairs, drug safety, and quality assurance teams, as ... of science, we're in. Are you?About the Role:We're looking for an Associate Director , Clinical Scientist for the Gene Therapy Clinical Development team to help us… more
- Merck & Co. (Rahway, NJ)
- …and maintain strong relationships with internal stakeholders, including commercialization, quality , analytical, regulatory , manufacturing, and Supply Chain to ... Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the Director… more
- Cipla (Central Islip, NY)
- Job Title: Director - Procurement, Cipla North America Reports to: Head SCM, Cipla North America Job Purpose The Director of Procurement is responsible for ... favorable contracts, identifying cost-saving opportunities, and maintaining compliance with regulatory and company policies. Success in this position requires deep… more
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