- Russell Tobin & Associates (San Diego, CA)
- What are we looking for in our R&D Quality Risk Management Manager ? The Scientific Team at Russell Tobin & Associates is supporting an exciting ... pharmaceutical organization that has an opening for an R&D Quality Risk Management Manager near...GCP regulated environment Experience in R&D Quality Risk Management or R&D QA systems and… more
- Tris Pharma (Monmouth Junction, NJ)
- …success. Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , ... standards and objectivesOversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event,… more
- Russell Tobin & Associates (Dublin, OH)
- What are we looking for in our Land Development Project Manager ? PrideNow is seeking a talented Land Development Project Manager to join an environmental ... on time, on budget, and with a focus on high- quality delivery while meeting project metrics Maintain and grow...development of strategy, the scope of work, evaluation of risk , and budget for projects Supervise and provide work… more
- Merck & Co. (North Wales, PA)
- …overseeing all PV processes, including adverse event reporting, signal detection, and risk management activities.-Manage PV systems : Responsible for managing PV ... Human Use (ICH) guidelines.-Maintain quality standards: Responsible for maintaining high- quality standards for PV processes and systems , and for implementing… more
- Catalent (San Diego, CA)
- …5 years' experience in QA/Regulatory Affairs areas with progressive responsibilities for quality metrics, quality systems , deviations, investigations, CAPAs ... Senior Manager , Quality AssurancePosition Summary:Catalent Pharma in...forms.Must have a demonstrable record of implementing and maintaining quality systems ; laying out a strategic plan… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Computer System Validation requirements, global regulatory compliance, and global Quality expectations. Partner with global Quality departments to review ... around rare diseases and immune disorders.Summary Manage Global DX Computer System Validation (CSV) projects within Daiichi Sankyo, for Computerized Systems… more
- Merck & Co. (Rahway, NJ)
- …medicine.We are seeking a Growth and Improvement minded Clinical Operations Manager - Regulatory that can help drive our Strategic Operating Priorities.Invent ... are a Competitive Advantage for UsSummary, Focus and PurposeThe Clinical Operations Manager - Regulatory is accountable for achievement and compliance for assigned… more
- Merck & Co. (Rahway, NJ)
- …with ICH/GCP and country regulations, our company's policies and procedures, quality standards and adverse event reporting requirements internally and externally.Our ... at study closeout. Oversees FCPA, DPS/OFAC, and maintenance of financial systems . Financial forecasting in conjunction with Sr.COM /other roles.Executes and oversees… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …design, transfer, and start-up of IT/OT projects Ensure compliance with the Quality Management System and Novo Nordisk IT/OT corporate requirements Lead ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...for selected candidate. Relationships Reports to: Sr. Operational Excellence Manager plus additional interfacing with Manager of… more
- Novo Nordisk Inc. (Boulder, CO)
- …project management experience Experience in pharmaceutical or biotech environment Experience in Quality systems and management a plus Excellent technical writing ... to support analytical and process development, the CMC team works alongside Quality , Regulatory, Technical Operations and RNAi Early Development professionals at our… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …validation, computer system validation and calibrationPerform functional and process risk assessments in conjunction with Quality and Manufacturing subject ... the validation team in the establishment and maintenance of validated systems . Coordinate technology transfer activities in support of commercialization. Serve as… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … System Manuals, Engineering Protocols and Reports, and other Quality System Documentation.Experience Requirements8+ years of experience with managing ... Position Summary The Manager of Automation Engineering leads Automation Engineers and...review, approve and control departmental documentation (eg, SOPs and system reports). Participate in document revisions, providing input, as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …evolve, so does our challenge to find better and more innovative ways to improve their quality of life. We're changing lives for a living. Are you ready to make a ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality ) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting ... annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs.… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …together to contribute to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a patient-focused mindset guides everything ... assistance eligible for selected candidate. Relationships Reports to: Sr. Manager Operational Excellence. Number of subordinates with direct/indirect referral: 6… more
- Insmed Incorporated (Bridgewater, NJ)
- …analysis (RCA) techniques requiredChange Control experience required Working knowledge of FDA Quality System Regulation, 21 CFR Part 820, ISO 13485:2016, ISO ... analysisParticipate in Management Review as related to combination products quality metricsReview PQC monthly metricsRisk assessment/Analysis/ Risk management… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to lead, support and report independent GCP audits according to Novo Nordisk quality systems , Good Clinical Practice (GCP) and current international and national ... and safety of our products. The Novo Nordisk Quality Management System (QMS) enables us to... manager Subject to alignment and approval from manager Embrace and drive Quality Audits key… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …to: Supervisor of IT Operations Direct Reports: None Essential Functions IT Infrastructure Manager , covering GxP and non-GXP systems : Drive and maintain IT ... to a better tomorrow for our patients. Ethics and quality are held in the highest regard, and a...design, installation, configuration, administration, and maintenance of network, security systems , servers, desktops, VoIP phones, AV systems … more
- Merck & Co. (Durham, NC)
- …generation/distribution, reverse osmosis skids, compressed gas systems ) Automated Systems (eg Distributed Control System (DCS), Programmable Logic ... of new systems which enhances the operation and/or engineering processes. Quality & Safety Compliance: The successful candidate should be able to examine an… more
- American Honda Motor Co Inc (Marysville, OH)
- …medium and high complexity as assigned and collaborates with Legal, Strategic Sourcing, Risk groups and Business groups to ensure that all contracts are compliant ... with company policies, risk and governance requirements. Contract Sr. Specialist is responsible...of business requirements with minimal guidance from Contracts team manager . Additionally, Contract Sr. Specialist is the primary interface… more
