- Legend Biotech USA, Inc. (Raritan, NJ)
- …people management and leadership experience is required.Experience working with quality systems is required.Extensive knowledge of chemical, biochemical ... treatment of multiple myeloma.Legend Biotech is seeking Head of Compliance as part of the Global Quality ...the supplier qualification program, including management of the electronic systems for this program.Work with External Quality … more
- Merck & Co. (Rahway, NJ)
- …into the Executive Director Packaging Technical Operations the Director Packaging Distribution, Components and Systems Center of Excellence ... compliant supply of commercialized products for the benefit of patients. The Director of Packaging Distribution, Components and Systems COE is integral… more
- Merck & Co. (Ames, IA)
- …and Supplier ManagementThe Director will report to the Animal Health Global Quality Lead for Compliance and Technical Support and will direct the below ... aspects of the Supplier Quality Management (SQM) and Animal Health global auditing program:ResponsibilitiesPerform comprehensive and detailed GMP compliance … more
- Merck & Co. (Durham, NC)
- …Influence, Leadership, Networking and Partnerships, Program Management, Quality Management Systems (QMS), Quality Strategy, Regulatory Compliance , Risk ... Job DescriptionWe're looking for a Director of Quality Assurance to lead...advise, problem-solve, and drive continuous improvementImplement and oversee fit-for-purpose Quality Management Systems and standard ways of… more
- Olympus Corporation of the Americas (Westborough, MA)
- …other functions and OCA sites to new ideas and ways to execute Quality Systems sub- systems to improve Olympus compliance profile. + Monitors plans and ... and OCA sites to new ideas and ways to execute Quality Systems sub- systems to improve Olympus compliance profile. + Ability to assess and develop… more
- Insmed Incorporated (NJ)
- …supporting biologics, drug products, or combination products.Deep knowledge of phase-appropriate quality systems , regulatory requirements (21 CFR Parts 210/211, ... from toxicology through Phase 3. This role ensures phase-appropriate GMP compliance across manufacturing development, while providing strategic Quality … more
- Novo Nordisk Inc. (Boulder, CO)
- … Assurance (QA) function and serves as the leading expert in quality , compliance , and quality management systems (QMS). Provide direction & coordinate ... through testing and quality programs to ensure product safety and quality Responsible for ensuring compliance with all regulatory requirements and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …s culture of excellence and compliance and working toward building a quality mindset with Medical Affairs.Support the Sr. Director 's Medical Affairs ... across all Medical Affairs programs. This role involves deputizing for the Sr. Director , representing the Quality organization at senior levels. The Director… more
- BeOne Medicines (Emeryville, CA)
- **General Description:** BeOne is seeking an Associate Director of GTS Governance, Risk, & Compliance (GRC) to build, enable and transform its risk management, ... North America & LATAM regions. The GTS GRC Associate Director is a critical position within the organization and...not limited to Finance, Internal Control, Internal Audit, Legal, Compliance , TechOps, R&D, HR, Quality and other… more
- Organon & Co. (Jersey City, NJ)
- …from various sources and create effective reports and solutions. + Proven quality systems management with analytical and data interpretation skills. + ... is achieved through close collaboration with key stakeholders in Commercial, Legal, Compliance , Privacy, Procurement, Business Technology, Quality & Audit, and… more
- Merck & Co. (Rahway, NJ)
- …design verification testing, and process validation, with a strong understanding of quality management systems and regulatory compliance .Exceptional project ... sustained launch in alignment with the company's business goals, and quality and regulatory compliance .Essential Duties and Responsibilities:Program Leadership… more
- Tris Pharma (Monmouth Junction, NJ)
- …strategies and operations, contract negotiations, supplier relationship management, procurement systems functionality/workflows and assurance of compliance with ... systems to maintain optimal stock levels and minimize obsolescence; Ensures compliance with safety, quality , and regulatory standards in warehouse… more
- Merck & Co. (Rahway, NJ)
- …Packaging Shipping Systems (Logistics and Distribution Technology)Reporting into the Director Packaging Distribution, Components and Systems COE, the ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionReporting into the Director , Logistics and Distribution Technology the Associate Director , Logistics and Distribution Technology will be ... products for the benefit of patients. The Logistics and Distribution Technology Director is integral to this mission. The successful candidate will possess deep… more
- Merck & Co. (Rahway, NJ)
- …Machine Learning (ML), Manufacturing Processes, Mechanical Testing, Medical Device Quality Systems , Medical Device Regulations, Medical Devices, Medical ... Process Manufacturing, Product Design, Production Process Development, Project Management, Quality Management Systems (QMS) {+ 4 more}Preferred Skills:… more
- Insmed Incorporated (NJ)
- …structures consistent with NIST and FDA data protection standards.Partner with Legal, Compliance , Clinical Operations, Quality and R&D to proactively manage risk ... EU GMP Annex 11, and GAMP 5 guidelines a plus .Experience collaborating with Quality , IT, and business stakeholders to ensure systems are validated and remain… more
- GRAIL (Durham, NC)
- …requirements. + Develops and provides inspection execution related training in support of compliance systems and quality improvements. + Partners with ... visit grail.com . As a key member of the Quality Leadership Team, the Director of ... Quality System inspections required by the Corporate Quality Systems Audit Program, which includes auditing… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Associate Director , Engineering as part of the Technical Operations team based in ... Raritan, NJ. Role OverviewThe Associate Director of Engineering is a strategic and operational leader responsible for the management, development, and performance of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …enhance global regulatory compliance to meet signal evaluation timelines.Develop quality systems and procedures for the signaling activities to assure ... continuous improvement around development of new signal workflow/process, development of quality systems and tools, updates to templates and procedural… more
- Bentley Systems (Exton, PA)
- …matters. The Tax Director will participate in all aspects of Bentley Systems US SALT compliance , planning, financial reporting and controversy efforts. The ... **Location:** Hybrid Exton, PA **Position Summary:** Bentley Systems is seeking an expwerienced Tax Director...as the financial reporting and accounting teams, regarding tax compliance and tax accounting issues. This is a high… more
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