- Pall (Miami, FL)
- …Danaher Business System which makes everything possible.Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets federal/state/international ... or material science fields with 15 years of progressive Regulatory compliance and / or quality assurance...of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100… more
- Merck & Co. (Rahway, NJ)
- …Position Overview - Basic Functions & Responsibility As a member of the Device Quality & Regulatory QMS group, the Associate Director will participate in and/or ... monitoring and re-evaluation, participating in supplier audits, and addressing any quality and regulatory issues.- This role aims to ensure compliance with MDCP… more
- Merck & Co. (Rahway, NJ)
- …tested, packaged, stored, and distributed aligned with our high standards of quality and meets all regulatory requirements. Partnering across our internal ... Regulatory Compliance, Policy Development, Process Facilitation, Process Improvements, Quality Improvement Programs, Quality Management, Regulatory … more
- Beckman Coulter Diagnostics (Miami, FL)
- …qualifications, and ongoing performance assessments to ensure adherence to internal quality standards, customer requirements, and applicable external regulatory ... and supply continuity risks.Collaborate with cross-functional teams across R&D, Procurement, Operations, Quality , and Regulatory Affairs to embed quality … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …for Legend Biotech.Lead and direct qualification activities to meet company goals, quality , and regulatory objectives. Qualification team will consist of ... the project engineering team and collaborate with other departments (Manufacturing, Quality , Regulatory , Development, Finance, and IT) on qualification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and implement proactive strategies to address data integrity issues identified during regulatory inspections, such as those from Quality Events, Audits Findings ... Quality OversightPlay a key role in ensuring compliance with regulatory requirements while driving innovative quality solutions.Collaborate with Global QMS… more
- Formation Bio (New York, NY)
- …role in scaling our biologics capabilities in partnership with technical, quality , and regulatory leaders.Responsibilities Strategic Leadership Develop and ... Collaboration & External Partnerships Partner closely with analytical development, manufacturing, quality , and regulatory teams to ensure seamless execution of… more
- Merck & Co. (Rahway, NJ)
- …for sustained launch in alignment with the company's business goals, and quality and regulatory compliance. Essential Duties and Responsibilities: Program ... collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality .Provide Voice of Manufacturing input to early… more
- Merck & Co. (Durham, NC)
- …of preventative and predictive maintenance programs to assure compliance with quality , regulatory , and reliability requirements and goals.Track maintenance and ... The site includes an Energy Center, Fill Finish Manufacturing Facilities, Quality Labs, various other manufacturing buildings and Maintenance and Material Storage… more
- Merck & Co. (Rahway, NJ)
- …requirements for CMC.- Strong understanding of integration and partnering with Quality , Regulatory , Operations, Non-clinical, Clinical, and other functional ... packaging, compatibility characterization for processing and administration, and supporting regulatory filings.Collaborate with key stakeholders across the organizations (Research… more
- Formation Bio (New York, NY)
- …and manufacturing organizations (CDMOs) in close collaboration with Quality and Regulatory colleagues.Responsibilities: Provide analytical development ... and ensure timely resolution. Collaboration: Collaborate cross functionally with Manufacturing, Quality , and Regulatory colleagues to ensure seamless integration… more
- Merck & Co. (Rahway, NJ)
- …strong relationships with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs, and external partners, to ... assessing, and mitigating potential risks to ensure patient safety and product quality .Ensure compliance with all regulatory requirements and quality … more
- Eisai, Inc (Raleigh, NC)
- …line extensions or site manufacturing changes in collaboration with Product Quality , Regulatory Affairs, and Technical Operations.Establish productive business ... (SCM) Unit is accountable and/or responsible for providing an uninterrupted supply of quality products to patients and DCU customers in their respective regions. The… more
- Merck & Co. (Sacramento, CA)
- …batch release.Additionally, this position will work directly with technical operations, quality , regulatory , microbiology, and analytical program leaders on a ... Job DescriptionThe Global Quality - Large Molecule Analytical Sciences (GQ-LMAS) team leads...documents to support Process Performance Qualification (PPQ), licensure and regulatory technical questions. SKILLS REQUIRED Minimum Education Required and… more
- Merck & Co. (Durham, NC)
- …as needed. Act as a validation subject matter expert in support of quality risk assessments and regulatory inspections. Partner with other area Validation ... Management Process, Manufacturing Process Validation, People Leadership, Process Optimization, Quality Risk Assessment, Regulatory Inspections, Regulatory … more
- Tris Pharma (Monmouth Junction, NJ)
- …gather and interpret dataContributes to research protocol and amendment developmentSupports regulatory submissions by preparing high- quality documents meeting ... writing expertise and leadership in the preparation of clinical and regulatory documents. Collaborating closely with cross-functional teams to ensure accuracy and… more
- BioAgilytix (Durham, NC)
- …tools that boost lab productivity and keep BioAgilytix ahead of regulatory requirements.Key ResponsibilitiesData Governance & Quality Standards:Develop a ... at diagnosing data challenges and designing innovative solutions to improve data quality , integration, and regulatory adherence.Capable of growing with the role… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …related topics and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.Ensures inspection ... database release, data review and cleaning, database lock), to ensure data quality /integrity and regulatory complianceEnsures that Data Management Plans are… more
- Twist BioScience (South San Francisco, CA)
- …by collecting, analyzing, and summarizing information and trendsWrite/review product quality documentationFollow regulatory and ISO 13485 requirementsWhat You'll ... He/she will work closely with the operations team to monitor the quality of Twist DNA products utilizing quantitative measurements, fragment analysis, NGS… more
- Merck & Co. (Rahway, NJ)
- …(GCD) regional office. Additionally, there are important interactions with, inter alia , Quality Assurance, Finance, Regulatory , Clinical Supplies and legal in a ... Clinical Practice (GCP), local and global policies and procedures to conduct high- quality , inspection ready studies is essential. The position is responsible for… more
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