- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Quality Assurance Group ensures every single material inside our products is manufactured, processed, tested, packaged, stored, and ... time, every time, across the globe.Summary, Focus and PurposeThe Director of GMP Compliance will report to...or similar scientific-discipline required with ten (10) years of quality , operational, or technical experience within the GMP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …properly investigated and that technology-related audits are conducted.Oversee and guide quality assurance processes related to project specifications, ensuring ... relevant training programs.Provide mentorship and guidance to RD PV QA on quality assurance practices and regulatory compliance.Keep abreast of evolving… more
- Eisai, Inc (Exton, PA)
- …will collaborate effectively with other Development groups as well as with Facilities, Quality Assurance , Quality Control, Regulatory, and CMC Program ... Interact cross-functionally with Support Services, Facilities, Biologics Process Development, Quality Assurance , Quality Control, Validation, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. JOB SUMMARYThe Senior Director , Head Medical affairs Quality Assurance in Global RD/PV ... QA is accountable to drive the implementation of a quality strategy and quality plan closely aligned...Medical Affairs LT, Specialty MA LT, Development (as applicable), GMP QA, and engagement with external partners as deemed… more
- Merck & Co. (Durham, NC)
- …Compliance:-Achieve compliance goals through a risk-based approach (Safety Regulations, Quality Assurance , Risk Management, Deviation Management, Product ... Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for… more
- Pall (Miami, FL)
- …which makes everything possible. Director Global Supplier QualityJob Description SummaryProvide quality assurance services to ensure the integrity of products ... manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …SummaryThis role is key leadership position within Global QMS and Global Quality Assurance . Overall accountability is develop strategic framework work for ... training across the organization. Work with functional GQA ( GMP RDPV) on implementation of strategy including development of...at least 5 plus years of experience within progressive GxP- Quality Assurance or equivalentMust have a minimum… more
- Pall (Miami, FL)
- …science fields with 15 years of progressive Regulatory compliance and / or quality assurance experience.Thorough understanding of ISO 9001 and AS9100 / CAA ... innovation.Learn about the Danaher Business System which makes everything possible. Director Global Quality and Regulatory ComplianceJOB SUMMARYInterprets… more
- Nitto Denko Corp. (Milford, MA)
- About this opportunity : The Director , Quality Assurance GMP Operations is responsible for quality oversight of the manufacturing process and ... and risk-based management activities. + Support the development / amendment of Quality Assurance Agreements with clients, GMP vendors and key raw material… more
- Regeneron Pharmaceuticals (Troy, NY)
- …as well as adherence to established due dates. + Interfaces regularly with Quality Assurance and other functional areas to remove obstacles, resolve issues, ... The Director , Global Procurement Compliance will be responsible for...successful projects. + Coordinate progress on all Global Procurement quality system results, ensuring quality and accuracy… more
- Lilly (Pleasant Prairie, WI)
- …driving solutions that impact the site and align with corporate objectives. The Associate Director , Quality Assurance , will also provide computer system ... production. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of...the site and align with corporate objectives. The Associate Director , Quality Assurance , will also… more
- Fujifilm (College Station, TX)
- …**:** Fujifilm Diosynth Biotechnologies Texas (FDBT) is seeking ** Quality Assurance (QA) Validation - Associate Director ** to oversee the review ... providing strategic leadership to the validation team. **Job Title:** Quality Assurance (QA) Validation, Associate Director...with cross functional teams and management to instill a " Quality Culture" by coaching personnel on GMP … more
- Lilly (Pleasant Prairie, WI)
- …quality improvements, increased productivity, and variability reduction. **Responsibilities:** The Senior Director , Quality Assurance , serves as the Site ... system. The individual in this role establishes the site's quality objectives, priorities, and roadmap. The senior director...+ Minimum of 10 years' leadership experience (Ideally in Quality Assurance ) + Demonstrated history of hosting… more
- OnKure, Inc. (Boulder, CO)
- …regulatory, clinical, and business operations goals. The ideal Quality Assurance candidate will have small-molecule, development-phase GMP experience, and ... Position Description: This position in Quality Assurance provides strategic and technical...Experience and Qualifications: Bachelor's degree or equivalent 10+ years ( Director ) of quality experience, in pharmaceutical industry;… more
- ThermoFisher Scientific (Richmond, VA)
- …to accuracy and quality to deliver groundbreaking innovations. The Senior/Executive Director Quality Assurance coordinates and ensures compliance with ... all quality assurance standards and regulatory requirements in the Bioanalytical and...relevant regulations, including CLIA, CAP, FDA, EMA, ISO 15189, GMP /GLP and other applicable standards + Serve as the… more
- Lilly (Branchburg, NJ)
- …to make life better for people around the world. Eli Lilly and Company seeks a Quality Assurance Associate Director (M2) to provide quality direction for ... to-day quality activities and technical challenges ensuring GMP compliance. Partner with the business to resolve critical...followed by 5 years of progressively responsible experience with quality assurance or quality control… more
- Catalent Pharma Solutions (Madison, WI)
- ** Director , Quality Assurance Operations** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... heart and lung diseases as well as Alzheimer's. The Director of Quality Assurance Operations...GMP products. + Supports the preparation of Product Quality Reviews; tracks and trends the performance of validated… more
- Bristol Myers Squibb (Indianapolis, IN)
- …The Associate Director of Chemistry, Manufacturing & Controls (CMC) - Quality Assurance develops and drives Quality (manufacturing and analytical) ... other tasks as assigned (eg, final Quality reviewer/approver of Quality events and/or GMP documentation, actively contributes to ongoing investigations… more
- WuXi AppTec (Middletown, DE)
- …will keep close cooperation with the Site Leadership Team, and will develop the Quality assurance team to support the creation of a culture that aligns ... has the flexibility to be hired at either the Director or Senior Director level dependent upon...10+ years of relevant experience or equivalent in pharmaceutical quality assurance and/or facility and equipment qualification.… more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …observations and commitments related to Sterility Assurance for the Kite Network. ** GMP Compliance and Quality Control:** + Ensure all sterility assurance ... expertise in microbiology and virology to cross-functional teams, including Manufacturing, Quality Assurance , Process Development, and Regulatory Affairs. +… more
