- Merck & Co. (Rahway, NJ)
- …Support compliance activities such as site readiness, audits, inspections, and CAPAs. Support quality risk management activities as facilitator, project lead ... Job Description Job Description The Rahway based Senior Specialist, Global Development Quality Operations...Quality Assurance (QA), Quality Assurance Systems, Quality Risk Management , Technical Writing,… 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 ... in working in a fast-paced environment, continuous improvement, change management , and risk management . Experience...Lead the team to develop and implement metrics including Quality Tolerance Intervals, Key Risk Indicators, Key… more
- Merck & Co. (Rahway, NJ)
- …manufacturing. -The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical ... technical responsibility and leadership of internal and external work.The Senior Scientist, Engineering position leverages scientific/technical experience to develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with strategic alignment.Effective in fast-paced environments with a focus on quality and documentation.Skilled in change management and guiding teams ... and propel data-driven decision-making.Promotes a culture of creativity and risk -taking, alongside developing processes that encourage experimentation and innovative… more
- Repligen (Waltham, MA)
- … quality assurance. Proven experience with ISO 9001 audits and supplier quality management . Strong problem-solving skills, including root cause analysis and ... 3 highly motivated and collaborative professionals responsible for managing supplier qualification, risk mitigation, and quality performance. The team plays a… more
- Repligen (Waltham, MA)
- …and management review meetings with the Senior Management team.Facilitate operational excellence initiatives in Quality Assurance.Maintain internal and ... external audit schedules; serve as host for site auditsMaintain risk -based strategy for overall Quality compliance across...experience in a cGMP, ISO 9001, or ISO 13485 Quality Management System environment required.Minimum 5-8 years… more
- Merck & Co. (Durham, NC)
- …technically strong individual and has the ability to communicate effectively with senior management on complex technical issues and manage multiple ... environmental, health, safety, and sustainability (EHS&S) opportunities.- Ensure comprehensive change management of all EHS and Site initiatives to ensure ongoing… more
- Merck & Co. (Rahway, NJ)
- …experts within the broader DD&T team (eg design verification, device risk management , human factors, technical integration, assembly automation, etc.), ... development, manufacturing process development, qualification, validation, and design control and risk management techniques to positively support and influence… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management , Deviation Management , ... investment requirements, and provide Operations input into Supply and Quality Agreements.- Launch Supply Risk Mitigation:-Ensure External Partner… more
- Merck & Co. (Rahway, NJ)
- …policy.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary. The candidate ... team environment with key stakeholders across the organizations such as Quality , Regulatory CMC, and technical functions, to ensure timebound progression of… more
- Aequor (Thousand Oaks, CA)
- …and advise Executive Management on short and long-term decision making. The Senior Manager will also work with site and regional planners to ensure 's ... Urgent role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this.… 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 ... has deep experience in procurement, strategic sourcing, and vendor management within the biotech, pharmaceutical, or life sciences industry.Responsibilities Develop… more
- Merck & Co. (Rahway, NJ)
- …interact and increase effectiveness by enabling clear, concise communication directly to senior management at our Company.Partners with members of GRACS ... efficiently on regulatory obligations, compliance requirements and company strategy.Providing quality advice to stakeholders creating optimal development, commercialization, and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …operations management , tech transfer, process and equipment validation or quality management ; with a preference for Cell/Gene Therapy experienceMinimum of ... Strong financial acumen with experience managing budgets, forecasts, and headcount planning. Risk Management : Ability to identify, assess, and mitigate… more
- Merck & Co. (Rahway, NJ)
- …and apply regulatory / compliance requirements relative to design controls and risk management activities.Lead the preparation of materials for program ... without formal authority; ability to influence and present ideas to senior leadershipExcellent communication, presentation, negotiation, project management , and… more
- Aequor (Thousand Oaks, CA)
- …and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management , and leading matrixed teams through influence to meet NPI ... and senior leadership team. Additional Responsibilities include: Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …solve complex problems Ability to effectively integrate and communicate insights to Senior Management teams, synthesize complex information, making it relevant, ... in support of company objectives, operating model decision, mitigate decision risk , drive action plan development and ultimately improve commercial and clinical… more
- Deloitte (Washington, DC)
- …we have the opportunity for you! What you'll do As a Tax Senior in our Quality Assurance & Risk Management practice, you will serve as a broad-based ... other strategic areas The Team The National Tax Quality Assurance and Risk Management (NTQA) senior is responsible for supporting the Deloitte Tax LLP… more
- Abbott (Pleasanton, CA)
- …You'll Work On** * Responsible for implementing and maintaining the effectiveness of the Risk Management Quality System element. * Interprets regulations and ... Management . * SME for domestic/international sites and affiliates regarding Risk Management Quality System element. * Works cross functionally with… more
- Lilly (Carolina, PR)
- …people around the world. **Responsibilities** The Senior Director, Global Process Owner for Quality Risk Management , as a leader within the Global ... and maintain the global quality system for Quality Risk Management . They will...The Senior Director, Global Process Owner for Quality Risk Management is responsible… more
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