- Merck & Co. (Rahway, NJ)
- …(GMPs) and other applicable worldwide regulations and our Company procedures.- The Senior Specialist will become knowledgeable in regulatory requirements, cGMPs ... Job Description Job Description: The Rahway based Senior Specialist, Global Development Quality Operations - API, is responsible for independent review and approval… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Establish strong and positive working relationship with OPDP reviewers. Report to Senior Director, Regulatory Affairs - Advertising & Promotion. Essential ... strategic guidance for responsible products and disease states based on current regulatory environment and competitive landscape Assess risk and advise on… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …promise of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Senior Project Manager , PMO as part of the Technical Operations team ... plans across functional teamsDefines the interdependent deliverables and ensures that quality, risk , cost, time are managed within the overall approved plan to drive… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …a proactive approach to ethics and compliance, focusing on partnership, risk mitigation, prevention, and the advancement of business development areas, including ... fields is preferred A minimum of eight (8) years combined pharmaceutical, legal, regulatory , and compliance experience required OR a minimum of six (6) years'… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal stakeholders include Medical & Science, Clinical Operations, Regulatory Affairs, Data Management, Biostatistics, Non-clinical, Medical Affairs, Marketing, ... ine management responsibility of Director/Associate Director Global Safety Lead, Senior Global Safety Scientist(s)/Global Safety Scientist(s) within the Safety… more
- Genmab (Plainsboro, NJ)
- …an innovative and growing organization? At Genmab, we're seeking a Senior Director, Strategic Planning & Effectiveness to drive cross-functional communication, ... This role will serve as Chief of Staff to the US, General Manager focusing on evolving operating models, building new capabilities, optimizing resources, and leading… more
- Insmed Incorporated (San Diego, CA)
- …for Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Senior Manager has responsibility for the QA oversight of ... Operations and CDMOs, associated vendors and contracted laboratories.Apply Quality Risk Management for key processes and systems. Identify improvement opportunities… more
- Novo Nordisk Inc. (Durham, NC)
- …process control systems to meet current & projected customer, business & regulatory requirements through the following activities: People Focus, Equipment Focus & ... Standards "Gatekeeper". Relationships Manager , Technical Support - OFP Essential Functions Work primarily...within compliance with a Quality Mindset that focuses on risk management & mitigation Implement effective Change Management Support… more
- Tris Pharma (Monmouth Junction, NJ)
- …in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems ... (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject matter ... and variances that occur during production or validationWork with Quality, Manufacturing, Regulatory , and subject matter experts to prepare for FDA and other agency… more
- Merck & Co. (Durham, NC)
- …comprised of fermentation, microfiltration/ultrafiltration, and chromatography steps.The Quality Senior Specialist provides expertise in the coordination of ... qualification/validation activities supporting the vaccine expansion facility.Primary Responsibilities:The Quality Senior Specialist will be responsible for comprehensive management of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …but not limited to, areas of vendor agreements, legal, business and regulatory issues. Coordination with, and appropriate supervision of, outside counsel as is ... of Company and/or departmental expectations and goals as identified by senior management.Responsibilities- Acts as a brand attorney and lead legal advisor… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Specialist, Quality Assurance Our Company will construct a new manufacturing facility to significantly expand its ... growth, harvest, lyophilization, product inspection, and quality control laboratories.The Senior Quality Assurance Specialist will support this expansion. Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …investments, companion diagnostic, academic research organization, and acquisition deals. Advises senior management on legal and regulatory issues, leads complex ... the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal… more
- Lundbeck (Walford, IA)
- …large pharma.Your new role The Head of Marketing for the UK & Ireland is a senior , strategic role with a dual purpose aligned to our strategy of becoming a Focused ... Cross-Functional Collaboration Collaborate extensively across local and global functions and senior leadership teams to ensure alignment and support for marketing… more
- Fidelity Investments (Boston, MA)
- …associates, and brand. We do this by helping Fidelity's business manage operational, regulatory and financial risk . The Enterprise Services Risk team ... will be a member of the dynamic and energetic risk team within Fidelity's Legal, Risk , and...is not limited to a criminal, civil litigations and regulatory review, employment, education, and credit review (role dependent).… more
- Fidelity Investments (Boston, MA)
- Job Description: Senior Manager - Global Financial Controls Center of ExcellenceThe Global Financial Controls Center of Excellence (GFC-CoE) is an enterprise-wide ... also provides advisory services for select strategic initiatives and modernization efforts.The Senior Manager role will deliver significant value to the business… more
- Fidelity Investments (Boston, MA)
- …us with the deep expertise necessary to build the future of finance. As a Senior Manager - Product Delivery Analysis on the FDA Product Delivery team you ... people. In our agile structure, you will function both independently and as a manager of Business Analysts. Your contributions will enable your team to develop in… more
- Fidelity Investments (Boston, MA)
- …or digital assets. You will have strong working relationships with Fidelity senior management, providing timely awareness of key risks, issues, and results with ... with a preference for a background in compliance, legal and/or regulatory experience.Proven knowledge of financial services industry, preferably in the areas… more
- Amazon (Arlington, VA)
- …to drive both tactical and strategic business decisions. A day in the life The Senior Risk Manager will set program objectives, assign appropriate metrics ... Want to help Earth's most customer-centric company design, implement and monitor risk mitigation strategies to improve the customer experience and protect Amazon's… more
