- Tris Pharma (Monmouth Junction, NJ)
- …and team success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety . The Director , Drug Safety is responsible ... for the development of ad hoc aggregate safety reports, periodic safety reports, signal detection activities and risk management planning. The incumbent… more
- Merck & Co. (Rahway, NJ)
- …expanding your career.The Chemistry, Manufacturing & Controls (CMC) Pre-approval Pharm Executive Director is accountable for managing a team of CMC professionals and ... high rigor in CMC regulatory strategy as well as delivery of high- quality CMC submissions for products which could span traditional solid-oral small molecules… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …productivity.Key Responsibilities Co-Lead Deviation Investigations: Collaborate closely with the Quality Associate Director to co-lead the deviation ... assessments to prioritize investigations based on potential impact on product quality , patient safety , and regulatory compliance. Address recurring deviations… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …coordinate and manage available resources in developing and delivering high- quality safety evaluation related documents/deliverables on time.- Coordinate ... areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product...(especially regulatory, but also expert advisory) interactions to ensure quality outcomes in the risk evaluation and… more
- Merck & Co. (Millsboro, DE)
- …DNREC, etc.) of animal facilities and program reviews is required.PurposeThe Associate Director /Attending Veterinarian will report to the Site Quality Head/ ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...facilitating communication between the Animal Services team and the Quality organization. This position will work in close coordination… more
- Merck & Co. (Rahway, NJ)
- …are available in some 150 markets.Accountable for all Environmental, Health, and Safety (EHS) program execution and compliance at our Manufacturing Division's Animal ... success.Primary Responsibilities: Demonstrate accountability and responsibility for Environment, Health, Safety and Sustainability (EHS&S) performance and compliance through active… more
- Catalent (Harman, WV)
- Position Summary The Director , Quality Systems is responsible for the management and oversight of the core quality systems, including investigation/deviation ... management, CAPA tracking, change control, risk management, supplier quality , audits and inspections,...all cGMP manufacturing operations and documentation and adhering to safety guidelines Oversee daily activity for the group to… more
- Insmed Incorporated (Bridgewater, NJ)
- …and procedures. In addition, the ED will be responsible globally for executing the safety and risk management activities for one or more clinical development or ... products in development and on the market.Accountable for the delivery of high quality and timely medical safety deliverables. Provides content guidance and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the end-to-end delivery of ... Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and External Vendors for the...on behalf of Daiichi Sankyo. This position also ensures quality delivery of all 3rd party data from diverse… more
- Merck & Co. (Rahway, NJ)
- …- Significant experience with engineering design, equipment operation, vendor interface, risk assessment, process safety and industry guidance are essential ... diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation. -… more
- Insmed Incorporated (Bridgewater, NJ)
- …in New York™, and Best Workplaces for Millennials™ lists.OverviewReporting to the Executive Director of Development Quality Assurance, the Senior Director of ... but not necessarily be limited to, the following:Facilitate and maintain a risk -based and scientific-based quality system to support Good Pharmacovigilance… more
- Merck & Co. (Rahway, NJ)
- …a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles ... across the organizations (Research Division/Manufacturing Division), such as Analytical, Quality , Regulatory CMC, and technical functions, to ensure timebound… more
- Merck & Co. (Rahway, NJ)
- …cross-functional areas consisting of all aspects of the business including Operations, Quality , Technology, Maintenance, and Safety . This position is located in ... diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety , Process Development, Technical Services, Utilities and Validation. Our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and Data Management, Regulatory Affairs, Quantitative Clinical Pharmacology, Clinical Safety and Pharmacovigilance, Regulatory/ Risk Management, Quality ... users to define user information needs.Provide informatics project management, SDLC Quality Model expertise, and computer system validation expertise to deliver… more
- Merck & Co. (Rahway, NJ)
- …an operating staff of 24-hourly employees and is accountable for production, quality , environmental and safety considerations of the Power Plant.Responsible ... Position Description: Powerhouse Chief Engineer Under the direction of the Associate Director of Engineering, The Chief Engineer is responsible for the supervision… more
- Merck & Co. (Durham, NC)
- …embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... system commissioning and qualification documents, change control, automation incidents, Quality Notifications (QNs), and other key automation-related processesProviding direct… more
- Merck & Co. (Rahway, NJ)
- …The Senior Specialist - Manufacturing Automation position will report to the Director , Engineering, Automation Lead position and will be a member of the ... prepare Standard Operating Procedures (SOP) and cGMP documents.Experience with Quality SystemsExperience in supporting compliance investigations and change management.Familiarity… more
- Option Care Health (Bannockburn, IL)
- …on integrating Quality Improvement and safety processes as appropriate. The Director , Quality and Risk Management reports to the VP, Quality ... committed to hiring, developing, and retaining a diverse workforce. Job Description Summary:The Director , Quality and Risk Management shall have oversight… more
- zobility (Bowling Green, KY)
- …systems, sustainability, environmental impact assessments, behavior-based safety , risk assessment *Working knowledge of Quality fundamentals, principles ... schedule to support a 24/7 operation Onsite position Plant Director of SHEQ Education: Looking for Food and Beverage... of SHE-Q is responsible for all aspects of Safety , Health, Environmental, Quality and Sustainability for… more
- Fidelity TalentSource LLC (Boston, MA)
- Job Description:The Risk Assessment and Testing Center of Excellence (CoE) is seeking a hardworking and driven professional to join the team! \u00A0You will help ... and works across Fidelity .The RoleThe CoE has set standards for performing risk assessments & controls testing and assessing the adequacy and effectiveness of… more
