- Hunt (Dallas, TX)
- … compliance program, including compliance audit planning and development of internal controls in furtherance of the compliance program. Model the ... Compliance Officer and Director of Enterprise Risk. Responsibilities: Lead the annual risk assessment to provide key input...special projects, as assigned. Required Skills: Expert knowledge of internal controls and associated compliance … more
- Merck & Co. (Rahway, NJ)
- …technical integration, assembly automation, etc.), as well as members of internal cross-functional product development teams from concept through product launch. The ... and regulatory aspects of combination products.The incumbent must be able to lead cross-functional development teams within DD&T and across our company, and work… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …applicable Develops comprehensive, relevant resources (eg training program, FAQs) to enable compliance with quality control process requirements across NNI and ... role fulfills the PV Oversight function in PV quality control processes, as well as providing SME-level input from...drift in external vendor and NNI processes to mitigate non- compliance and deviation occurrence Support internal and… more
- Merck & Co. (Durham, NC)
- …Our company in the United States and Canada, is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health ... facility in Durham NC, the Supply Chain Logistics Strategy Leader will be responsible for the development, management, and...any new projects.- This includes SME support during routine internal and external GMP and Financial audits, QSAT actions,… more
- Merck & Co. (Rahway, NJ)
- …reputation through conference participation.Represent BPR&D as a upstream bioprocess expert/co- leader in internal and cross-functional project teams.Supervise, ... medical breakthroughs. We are looking for a collaborative, self-motivated -scientific leader with expertise in downstream bioprocessing to join Biologics Process… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead , you will report into Director, Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... mitigate risks, and continuously enhance performance.Maintain a strong focus on compliance and Environmental Health and Safety (EHS) to drive supply excellence.Serve… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and ensure safe and compliant manufacturing operations according to cGMP requirements. Lead a ~250+ organization responsible for either the non-sterile or sterile ... and productivity improvements.Support manufacturing investigations, support and manage change controls , and maintain permanent inspection readiness and actively support… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... industry. This leader will be responsible for managing the site quality...& Proteins.ResponsibilitiesThe Director, Quality will be responsible for:Maintaining site compliance to ISO 9001 for all aspects of the… more
- Formation Bio (New York, NY)
- …and more efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to ... large molecule programs from early development through commercialization. You will oversee internal and external teams, ensure regulatory compliance , and play a… more
- Twist BioScience (South San Francisco, CA)
- …experienced and highly motivated Manufacturing Execution System (MES) Director to lead the strategic development, implementation, and optimization of our custom, ... align with our overall manufacturing strategy and business objectives. The Director will lead a team of MES professionals, primarily software developers, who work in… more
- Merck & Co. (Durham, NC)
- …Position Overview : Our Company is seeking a dynamic and versatile leader for External Manufacturing Operations, Drug Delivery Systems and Devices within our ... establishing a strong business partnership and ensuring excellence in Compliance , Supply, Continuous Improvement, and Cost Management.--The Associate Director,… more
- Merck & Co. (Rahway, NJ)
- …Downstream Purification-department is seeking a passionate and skilled individual to lead the charge in transforming our late-stage pipeline and commercial products ... reality.What You'll Do:As a key player in our BDSC team, you will: Lead and Collaborate: Participate in and/or spearhead cross-divisional technical teams focused on… more
- Merck & Co. (Rahway, NJ)
- …analytical control strategy development and execution. Demonstrated ability to lead a technical team and develop talent through good mentoring skills. ... the group Director to define group strategy and to lead a team of scientists in solving complex analytical...and experience with regulatory guidance and industrial standards of control strategy for residual HCPs and other process related… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to identify market trends, leading a high-performing team while ensuring compliance with legal standards. The Director will drive informed decision-making and ... Relationships Reports to the VP, Enterprise Insights. Has responsibility of cultivating internal and external relationships that bring value and insights to the… more
- Merck & Co. (Rahway, NJ)
- …primary program-level GCS point of contact representing the GCS Planning organization to customers both internal and external to GCS and serve s as the lead GCS ... Interacts closely with key partner organizations ( as a lead GCS Planning program representative ) such as clinical...applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los… more
- Repligen (Rancho Dominguez, CA)
- …are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, manufacturing support, and technology transfer efforts at ... a Subject Matter Expert for TFF and other bioprocessing manufacturing systems. Lead projects in equipment design, tech transfer, process validation, and facility… more
- Merck & Co. (Rahway, NJ)
- …(SM PR&D) organization. The SSO pilot plant enables gain of critical internal experience with scale-up of manufacturing GMP steps, demonstration of new manufacturing ... will provide hands on assistance for daily production activities while ensuring compliance with Safety & Environmental (S&E) and current Good Manufacturing Practices… more
- Merck & Co. (Rahway, NJ)
- …Driving License:Hazardous Material(s):Required Skills:Business, Business, Compliance Investigations, Confidentiality, Cross-Cultural Awareness, Detail-Oriented, ... Control Systems, Electronic Common Technical Document (eCTD), Ethical Compliance , Global Health, Global Program Development, High Performance Team Building,… more
- Goldman Sachs, Inc. (Salt Lake City, UT)
- …with stakeholders to perform control design assessment and challenge risks and controls . Lead and design audit testing to ensure audit fieldwork is focused ... control processes. Who We Look For Goldman Sachs Internal Auditors demonstrate a strong risk and control...of relevant work experience in Internal Audit, Compliance , or Risk / Controls functions Experience… more
- Merck & Co. (Rahway, NJ)
- …tight timelines, in a rapidly changing environment - Experience and aptitude to lead , work, and collaborate in internal and external cross-functional, matrixed ... & Manufacturing, in a fast-paced, multidisciplinary environment- - Participate in or lead 1) development of robust and scalable purification processes for biologics… more
