- Aequor (Newbury Park, CA)
- …deliver training materials and presentations to a global audience. Author/review/approve quality Regulatory Information Management & Systems documents Analysis ... in what we do. Detail oriented, to be able to monitor data quality . Comfortable learning new systems/processes. Someone who is able to follow instructions/guides,… more
- Option Care Health (Tallahassee, FL)
- …patients we serve.Job Description Summary:The Senior Manager, Naven health Regulatory and Quality shall have oversight responsibility for designing, ... all Quality Nurses reporting directly to the Senior Manager of Quality and Regulatory...revision and implementation of policies and procedures to ensure compliance with accreditation standards, regulatory agencies, and… more
- Merck & Co. (Durham, NC)
- … Control will be accountable for activities that support cGMP and regulatory compliance during method qualification/validation and routine product testing to ... to produce the bulk active ingredient, finished product, and laboratory testing. - The Senior Specialist, Quality Control participates in a team of analysts in… more
- Catalent (San Diego, CA)
- … Quality performance, Operational Excellence, continuous improvement, error reduction, regulatory compliance , and sound fiscal responsibility. The primary ... Senior Manager, Quality AssurancePosition Summary:Catalent Pharma...include activities related to GMP (Good Manufacturing Practices) and regulatory oversight, quality support to operations and… more
- American Honda Motor Co Inc (Marysville, OH)
- …America. AHM Audit also promotes self reliance within NA operations and ensures regulatory compliance while maintaining competitive costs but with the highest ... support the North American Regional Operating Board (NAROB) and senior executives across North America to strengthen risk management,...quality and efficiency of our products and services to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ongoing process improvement related to data governance to ensure data integrity, quality , consistency, and compliance with regulatory requirements.Define ... defined, R&D data governance approach to facilitate consistency and quality of data across key Daiichi Sankyo regulatory...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as… more
- Catalent (Manassas, VA)
- …and prospective suppliers in compliance with Global procedures and Regulatory requirements Generate Global Quality Agreements in accordance with templates ... Senior Quality Auditor Position Summary: Catalent... Senior Quality Auditor Position Summary: Catalent is a global,...committed to a Patient First culture through excellence in quality and compliance , and to the safety… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... authorities; Oversees management and performance of CRO. Occasional interactions with CRO senior leadership as needed; Participates in creation of developmental and … more
- Mindlance (North Wales, PA)
- …between support functions worldwide for complaint-handling activities to maintain regulatory compliance . . Provides expertise in complaint-handling processes ... Job Title: Senior Specialist Quality Assurance Job Location:...Quality Investigation (AE-QIR) intake management processes comply with regulatory expectations. . Responsible for receipt, processing, and follow-up… more
- Catalent (Harman, WV)
- …stakeholder satisfaction.Catalent is committed to a Patient First culture through excellence in quality and compliance , and to the safety of every patient, ... to ensure a process of business recovery of cost changes as appropriate.Maintain compliance with all regulatory requirements and ethical standards related to… more
- Merck & Co. (Durham, NC)
- …and embrace an empowered team culture including significant interaction with manufacturing, quality , IT, and engineering groups. - The Senior Specialist for ... Job DescriptionPosition Description: Senior Specialist, Manufacturing Automation The Senior ...improve manufacturing performance, and maintaining the automation systems in compliance with cGMPs. The Manufacturing Automation Sr. Specialist must… more
- Merck & Co. (Rahway, NJ)
- …audits/inspections and overall site performance.Identifies, assesses and resolves site performance, quality or compliance problems and escalates per defined CRA ... sensitive working relationships.Demonstrates commitment to Customer focus.Works with high quality and compliance mind-set.Positive mindset, growth mindset,… more
- Integrated Resources, Inc (Spring House, PA)
- …between support functions worldwide for complaint-handling activities to maintain regulatory compliance . . Provides expertise in complaint-handling processes ... Job Title: Senior Specialist Quality Assurance - Level...Quality Investigation (AE-QIR) intake management processes comply with regulatory expectations. . Responsible for receipt, processing, and follow-up… more
- Nesco Resource (Devens, MA)
- …trends and corrective action by coordinating with customers and suppliers. Ensures compliance to specified quality requirements by performing in-house and ... to be considered.- Customer inter-facing experience- New Product Development- Internal quality management- DSQR - Designated Supplier Quality Representative… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, ... The Associate Director, RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small… more
- Merck & Co. (North Wales, PA)
- …data management conceptsExperience in CDISC and ADaM standardsExperience ensuring process compliance and deliverable quality .Strategic thinking - ability to turn ... stakeholder requirements.Preferred Experience: Demonstrated success in the assurance of deliverable quality and process compliance . Strong working knowledge of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and strong collaborators, as we embark on shaping our future. The Position The Senior Manager - New Product Commercialization (NPC) and 5D will lead and execute ... plan alignment. Other internal relationships include those with Medical, Sales, Regulatory , Legal, Market Access, Global Marketing and Global Medical. External… more
- Novo Nordisk Inc. (Boulder, CO)
- …to support analytical and process development, the CMC team works alongside Quality , Regulatory , Technical Operations and RNAi Early Development professionals at ... & other validation activities Review & approve validation procedures, specifications & quality documents for accuracy & compliance Presentation & support for… more
- Novo Nordisk Inc. (Durham, NC)
- …customer requirements Ensure processes and roles are established and capable to meet quality specifications & requirements, to include GMP Compliance of the team ... our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. In NC, we operate… more
- Cambia Health Solutions, Inc (Portland, OR)
- …to support strategy and action, utilizes operational data to demonstrate regulatory compliance , and develops MHPAEA-related analytics tools. Reports directly ... Data Reporting Analyst Senior - Mental Health ParityRemote in ID, OR,...compliance with MHPAEA data reporting requirements. Translate complex regulatory data requirements of MHPAEA into actionable and reportable… more
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