- Merck & Co. (Rahway, NJ)
- …recurrence. Identify and design improvement opportunities within the Support Model to reduce compliance risk and increase efficiency for the Support Team and End ... Job DescriptionAssociate Director , Business System Labeling Management Required experience and...Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance , Regulatory Compliance , Regulatory… more
- Merck & Co. (Upper Gwynedd, PA)
- …(BLA), Electronic Common Technical Document (eCTD), Immunochemistry, International Regulatory Compliance , Microbiology, Molecular Microbiology, Pharmaceutical ... through product development including assessment of the probability of regulatory success together with risk mitigation measures.-Lead...Process Development, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory … more
- Merck & Co. (Rahway, NJ)
- …Development and with external suppliers.Understand and apply regulatory / compliance requirements relative to design controls and risk management ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Insmed Incorporated (San Diego, CA)
- … of Clinical Quality Assurance (CQA) serves as a strategic leader managing quality and regulatory compliance related to GCPs, acts as quality lead on the gene ... a risk -based and scientific-based quality system to support GCP.Oversee regulatory agency inspections and vendor audits.Ability to ensure that a strategic audit… more
- Merck & Co. (Rahway, NJ)
- …development and lifecycle management, ensuring compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive ... in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership and Project… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …teams, manage performance, and develop talent. Ability to create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA, EMA, and ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Formation Bio (New York, NY)
- …CMOs, software vendors, and other biotech service providers. Knowledge of contract law, risk management, and compliance in vendor agreements. Ability to work ... bring new treatments to patients faster and more efficiently.About the roleThe Director , Procurement will be responsible for establishing and managing a strategic… more
- Merck & Co. (Rahway, NJ)
- …Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and ... as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for… more
- Repligen (Waltham, MA)
- …, Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across… more
- Merck & Co. (Durham, NC)
- …Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization ... Lead Periodic Business and Operations Review Meetings (with External Partner).-- Compliance :-Achieve compliance goals through a risk -based approach… more
- Merck & Co. (Rahway, NJ)
- …pipeline programs using fed-batch and continuous manufacturing platforms. The Director , Biologics Process Development (BPD) within the Biologics Process Research ... development, tech transfer of clinical or/and commercial processes, and pertinent regulatory filings. The incumbent will be responsible for recruiting, appraising,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision ... position requires strong knowledge about RBQM, and related processes, policies, regulatory requirements and ICH guidance. This position requires excellent project… more
- Merck & Co. (Rahway, NJ)
- …equipment and processes for medical devices/drug delivery systems. Reporting to the Director responsible for this area, you will partake in medical device assembly ... technical content of assembly process FMEAs to capture patient and process risk and identify appropriate in-process controls to ensure robust and efficient… more
- TD Bank (New York, NY)
- …support a strong risk culture and comprehensive approach to managing regulatory compliance risk . This Director - Compliance Testing Team Lead ... for this role. **Job Description:** TD has enhanced its Regulatory Compliance Management Framework (RCM) and is... requirements and assisting business units to manage their regulatory risk . **Key Responsibilities:** + Assist in… more
- Anywhere Real Estate (Baltimore, MD)
- …of the Global Information Security team, the Director of Risk & Compliance (Data Privacy and Regulatory Compliance ) will spearhead the global data ... Product & Technology. This strategic role focuses on embedding privacy-by-design and regulatory compliance into the design, development, and operation of… more
- Citigroup (Charlotte, NC)
- … management policies, systems, infrastructure and data requirements. + Maintain strict compliance with all risk -related regulatory requirements to ensure ... regulatory capital management, including the measurement and reporting of spot regulatory capital and risk weighted assets ("RWA"). FINCRO's oversight of… more
- Walmart (Bentonville, AR)
- …Walmart's Data and Technology team as Senior Director and Lead Counsel, Enterprise Regulatory and Risk (US Privacy)! This is an exciting opportunity to make ... complex US privacy regulatory issues, designing and implementing enterprise risk mitigation strategies, and overseeing compliance efforts across Walmart's US… more
- Oregon State University (Corvallis, OR)
- …develops, implements, and oversees the college-wide safety and regulatory compliance program. This includes conducting risk assessments, ensuring alignment ... the primary liaison with OSU Environmental Health & Safety, Risk Management, and other relevant entities. The role ensures...budget planning, coordinating land use, ensuring regulatory compliance , and managing assets. The director serves… more
