- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning,… more
- Candela Corporation (Marlborough, MA)
- …marketing organizations. **Job Summary Overview and Job Responsibilities** In this position, the Senior Director , Global Compensation and Benefits (C&B) is ... ** Senior / Director , Global Compensation...** Senior / Director , Global Compensation and Benefits** Requisition... regulatory requirements. In this position, the Sr. Director strategizes (with the CHRO) to align global… more
- ThermoFisher Scientific (Waltham, MA)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** The Senior Director , Pharma Services Group (PSG) Global Controller acts as a ... activities of PSG, ensuring compliance with US GAAP, SOX, internal policies, and other regulatory standards. + Lead a team of senior -level divisional and site… more
- Bristol Myers Squibb (Devens, MA)
- …personal lives. Read more: careers.bms.com/working-with-us . **Position Summary** The Executive Director , Cell Therapy Global Product Quality (CTGPQ) is ... and supports development teams, including comprehensive input into strategy during all global clinical and commercial regulatory filings. This position leads a… more
- Bristol Myers Squibb (Devens, MA)
- …and cell therapy as well as distributors and local markets inclusive of global regulatory agencies worldwide. Serves as consultancy to sites/functions with ... regulatory inspections including Pre-inspection readiness. **Key Responsibilities** . Responsible...business priorities), including significant experience working cross-functionally and in global teams. . Demonstrated ability to work effectively in… more
- Charles River Laboratories (Shrewsbury, MA)
- …career that you can feel passionate about. **Job Summary** This is a senior management position within the company with overall responsibilities for the operations ... with colleagues to develop plans when necessary to address material shortfalls ** Regulatory ** *Ensure that processes fully satisfy regulatory requirements as… more
- Olympus Corporation of the Americas (Westborough, MA)
- …adequate support at global and regional levels. + Ensure the appropriate global regulatory requirements, are considered as part of due diligence and ... regulatory documentation is maintained, well-organized and ready to be audited by global regulatory authorities / notified bodies. + Develop an understanding… more
- Bristol Myers Squibb (Devens, MA)
- … Director of Validation, Cell Therapy Technical Operations reports to the Senior Director , Cell Therapy Technical Operations within the Cell Therapy ... via internal and external manufacturing sites. This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop… more
- ThermoFisher Scientific (Waltham, MA)
- …Quality standards, regulatory requirements and customer expectations are maintained. The Senior Director will champion and pursue and promote a premier ... PPD. For more information, please visit www.thermofisher.com . **Position Summary:** The Senior Director Quality, Large Molecule is an executive level leadership… more
- Nitto Denko Corp. (Milford, MA)
- …experience working for a CDMO is preferred. + Current and in-depth knowledge of global cGMP regulatory requirements. regulatory changes, industry trends and ... About this opportunity : The Director , Quality Assurance GMP Operations is responsible for...and reports). + Support or lead client audits and regulatory inspections, ensuring inspection readiness. + Ensure timely and… more
- Hologic (Marlborough, MA)
- …Quality Marlborough, MA, United States San Diego, CA, United States Job Overview: The Senior Director of Mergers and Acquisitions (M&A) Quality is an integral ... part of the global Quality leadership team. This role is responsible for...detailed reports on quality assessments, findings, and recommendations to senior leadership and key stakeholders. + Collaborate with division… more
- ThermoFisher Scientific (Waltham, MA)
- …Fisher as a leader in the CRO industry and was one of the largest global transactions in 2021. Other transactions spanned the scope of our entire business including ... and investment agreements. + Advise Corporate Development, Strategic Capital, and other senior leaders on issues related to the inorganic growth pipeline, including… more
- Bristol Myers Squibb (Devens, MA)
- …+ Ability to accurately and completely understand, follow, interpret and apply Global Regulatory and cGMP requirements. + High problem-solving ability/mentality, ... no better place than here at BMS with our Cell Therapy team. The ** Senior Specialist, QC Materials Management** is responsible for the management of materials used… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . The ** Senior Manager, Project Management** will manage and/or support the aspects of ... on time & within budget. This role will report to the Associate Director , Project Management Office (PMO) and Business Operations. **Shifts Available:** Monday -… more
- Hologic (Marlborough, MA)
- …also fostering the development and engagement of a high-performing team. Reporting to the Senior Director of Marketing, this role is ideal for a seasoned ... Manager, Downstream Marketing (Radiology) Marlborough, MA, United States Title: Senior Manager, Downstream Marketing - Radiology Division Location: Marlborough, MA… more
- Actalent (Harvard, MA)
- …to detail and time management skills. This role will report to the Devens Associate Director Cell Therapy Site Procurement Lead and can be based at one of the BMS ... and milestones are met. - Consistency in Processes: Ensure consistent site and global transactional ways of working through the entire migration process for all… more
- Bristol Myers Squibb (Devens, MA)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Reporting to the Director of OpEx, PMO & L&D the ** Senior Manager, OpEx** will be ... by networking within the Devens site, campus, GPS Biologics Operating Unit and Global GPS OpEx team. **Knowledge and Skills:** + Excellence in business change… more