- Merck & Co. (Rahway, NJ)
- …portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team ... Manufacturing Division / our Research & Development Division ) such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Merck & Co. (Durham, NC)
- …routine internal and external GMP and Financial audits, QSAT actions, to ensure compliance .- This is a fast-paced and multi-faceted role that provides leadership and ... a wide range of business activities.- Reporting directly to the Director , Supply Chain Management, the successful candidate's primary responsibilities will include… more
- Repligen (Waltham, MA)
- …Assurance.Maintain internal and external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across the ... OverviewWe are seeking an experienced Director of Quality candidate to lead... Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance … more
- Merck & Co. (Rahway, NJ)
- …launch in alignment with the company's business goals, and quality and regulatory compliance .-Essential Duties and Responsibilities:Strategic Leadership ... compliance with relevant regulatory standards.Ensure robust technical plans, risk communication, drive technical and programs decisions through the development… more
- Merck & Co. (Rahway, NJ)
- …Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance , Risk Management, Sourcing and Procurement, Strategic ... a lead GCS Planning program representative ) such as clinical development, regulatory, quality and other supply chain areas to negotiate timelines ,- strategies and… more
- Merck & Co. (San Francisco, CA)
- Job Description Position Description: Associate Director , DSCS Digital Implementation Project ManagerWithin the Development Sciences and Clinical Supply (DSCS) ... interdependent across our functional areas, Discovery, our Manufacturing Division Quality , and BARDS, to name a few, and with...of the DSCS Digital Program Mgmt Lead, the Associate Director , DSCS Digital Project Manager, will be responsible for… 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. (Upper Gwynedd, PA)
- …Scientist, CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical CMC is ... including assessment of the probability of regulatory success together with risk mitigation measures.-Lead development and execution of global product and project… more
- Merck & Co. (Rahway, NJ)
- …accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable for ... proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across… more
- Merck & Co. (Durham, NC)
- …External Partner).-- Compliance :-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management, ... Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director , External Manufacturing Operations will also assist in commercialization… 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 ... and downstream processes that produce high yields along with superior product quality and allow speedy progression for clinical studies and commercial launch. The… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director , Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM ... source data review. Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key Performance Indicators, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …forecasting to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed ... in? Are you ready to experiment with us? The Position The Director , Market Intelligence and Portfolio Insights will leverage Competitive Intelligence methodologies… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection ... of group members. This position also monitors trends in functional performance via quality , time, and cost indicators, and develops plans and leads the execution for… more
- USAA (Phoenix, AZ)
- …activities are effectively identified, measured, monitored, and controlled in accordance with risk and compliance policies and procedures. What youll have: ... of what truly makes us special and impactful. The Opportunity As a dedicated Director , Underwriting Research , you will be responsible for Managing a team of staff… more
- Merck & Co. (Rahway, NJ)
- …regulatory submissions.-Under the general scientific and administrative direction of the Director in Biologics Cell Culture Sciences group and working in conjunction ... a cross-functional team.-Ensures project results meet requirements regarding technical quality , reliability, schedule, and cost.Monitors performance and recommends schedule… more
- Mary Greeley Medical Center (Ames, IA)
- …| On-Site Mary Greeley Medical Center (MGMC) is seeking a strategic and experienced Director of Quality , Accreditation, and Compliance to lead our ... external auditors. Build and lead a high-performing team across quality -related functions. About the Role: The Director ...quality (eg, CPHQ), patient safety (eg, CPPS), or compliance (eg, CHC). Experience managing high- risk events… more
- BioSpace (Bridgewater, NJ)
- …(TM) , and Best Medium Workplaces (TM) lists. Overview The Executive Director (ED) will lead Global Medical Safety Strategy for all Insmed's investigational ... integration of new technology and processes to enhance patient safety and benefit risk management. The ED will provide day-to-day leadership and guidance to the… more
- Citigroup, Inc. (Irving, TX)
- …Within T&BE, the Chief Operating Office (T&BE COO) drives a strong focus on risk and controls, compliance and value across T&BE organization and oversees ... globally. This is a role reporting to the Data Quality Assurance Director based in London, Mumbai...timings accordingly will remain flexible. Qualifications: Strong experience in risk and control, supervision, quality assurance/ control… more
- BillionToOne (Union City, CA)
- …to help build the future of precision medicine, this is where you belong. As the Director of Quality , you will be responsible for leading the implementation of ... quality management system, but also to develop quality programs that ensure compliance with policies...the only non-invasive prenatal screen capable of assessing fetal risk for both common recessive conditions and aneuploidies from… more
