- Vera Therapeutics (Brisbane, CA)
- Title: Senior Director , GxP Compliance Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused ... medical treatment for patients suffering from immunological diseases. Position Summary: The Senior Director , GxP Compliance will be focused on leading… more
- Schrodinger (Cambridge, MA)
- We are looking to hire a ** Director , GxP Quality Assurance and Compliance ** to join us in our mission to discover and develop drugs that improve human health ... label review, risk management, and eQMS (MasterControl) + Ensure compliance , in collaboration with relevant SMEs and senior... compliance , in collaboration with relevant SMEs and senior leaders, with all applicable GxP regulations,… more
- Lilly (Indianapolis, IN)
- …passion for understanding Artificial Intelligence systems and related quality controls?** As the Senior Director of AI Quality Assurance, you'll be at the ... must be managed responsibly and effectively, particularly in the pharmaceutical environment. The Senior Director of AI Quality Assurance is part of the Global… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …and improve life by advancing the care of patients with life-threatening diseases. The ** Senior Director , Head of ERP DevOps** will be responsible for overseeing ... and Secondary Packaging. Release 3's target completion date is 2025-2026. The ** Senior Director , Head of ERP DevOps** will support business strategy.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …well as encouraging and facilitating presentations and creating a collective voice for Gilead GxP compliance . + Serves as point of contact and R&D Quality voice ... regulatory agencies. You will collaborate cross-functionally to ensure Gilead's ongoing regulatory compliance and R&D GxP quality operations in accordance with… more
- Astellas Pharma (Sanford, NC)
- **Quality Assurance, Site Leader ( Senior Director )** Are you ready to use your experience and expertise to make an impact on patients' lives? Astellas Gene ... a part of our journey. Astellas is announcing a **Quality Assurance Site Leader ( Senior Director )** opportunity at their **Astellas Gene Therapy (AGT)** site in… more
- AbbVie (Irvine, CA)
- …Neurotoxin Research Group at AbbVie seeks an accomplished scientist and leader. The Director / Senior Principal Research Scientist will lead a team performing in ... maintain a productive, collaborative, and inclusive laboratory environment in compliance with regulatory and company expectations. Experience managing projects from… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …compliance , learning, and documentation operations. This position is directly under the Senior Director , GSC Strategic Capabilities and will serve as a ... that upskill and build knowledge capabilities in an organization. + Expertise in GxP compliance , Quality Systems, and global regulations, with strong knowledge… more
- Abbott (Alameda, CA)
- …of regulatory requirements specific to the medical device industry, including experience with GxP validation and compliance . The base pay for this position is ... Our 114,000 colleagues serve people in more than 160 countries. The Sr. Director IT, Business Relationship Management is a global leader tasked with developing and… more
- AbbVie (Irvine, CA)
- …approaches to advance quality assurance excellence mindset. The role reports to the Senior Director of Safety, Vigilance and Medical Affairs Quality Assurance. ... and medical affairs corporate and/or organizational policies/procedures. Partners with the Director , R&D Quality Assurance on cross- GxP standards and those… more
- BeiGene (Emeryville, CA)
- …as assigned. **Essential Functions of the job:** + Independently lead/participate in GxP compliance activities (internal/corporate, CMO or supplier, CRO) and ... overdue records related to KPI reports. + Consistently provide senior management with reports on the progress of quality...CAPAs/audits and assess corrective measures for internal and external GxP Compliance audits. + Work with Global… more
- BeiGene (San Mateo, CA)
- …metrics information to CMO vendor management team and escalate any quality or compliance issue timely to senior management when needed. + Closely collaborate ... tasks as assigned in accordance with SOPs, regulatory agencies and GxP guidelines **Supervisory Responsibilities:** + Responsible for management, development and… more
- Lilly (Indianapolis, IN)
- …Transformation and Technology reports to the Sr. Vice President, Global Quality Compliance . **Key Objectives/Deliverables:** The Senior Director , Quality ... to support communities through philanthropy and volunteerism. **Responsibilities** : The Senior Director of Quality Transformation and Technology is responsible… more
- BeiGene (San Mateo, CA)
- **General Description:** The Associate Director of R&D Quality Systems, Strategy, and Excellence (Strategy & Innovation) is responsible for leading initiatives that ... that improve quality outcomes and enhance decision-making processes. The Associate Director will drive cultural change and system modernization, ensuring that… more
- Bristol Myers Squibb (New Brunswick, NJ)
- …* Drive operational excellence, continuous improvement, and process maturity, ensuring compliance with GxP regulatory requirements, BMS Quality standards, and ... **Key Responsibilities** Maintain global processes, procedures, and training materials in compliance with Global GxP requirements. * Drive optimal execution… more
- Sokol Materials & Services (Skillman, NJ)
- … CQV Apply Now (https://forms.monday.com/forms/3cdf5bfb73703e4a3aa29c55653510f4?r=use1) Job Type Senior Workspace Hybrid About the Role This role involves ... and execution of CQV strategies, managing client relationships, and ensuring compliance with regulatory requirements. The Associate Director CQV engages… more
- Novo Nordisk (Plainsboro, NJ)
- …focused on Patient Solutions Transformation. Relationships This position reports to a Director / Senior Director in Business Applications within the ... of responsibility + Leverages Technology Principles, Knowledge, And Practices: Ensures compliance with NN Agile Project Management Methodologies, Privacy and GxP… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …addressed and managed appropriately. Ability to exercise influence at the senior leadership and/ or executive level wherever GLP/non-GLP/ research programs impacting ... to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively… more
- Amgen (Washington, DC)
- …governance, data stewardship & execution, and data quality management while ensuring compliance with industry regulations, such as GMP/ GxP and FDA requirements. ... of pharmaceutical industry operations, including manufacturing, supply chain, regulatory compliance , and quality control. The Associate Director will… more
- United Therapeutics (Silver Spring, MD)
- …needs within the facilities department to meet operational objectives and regulatory compliance + Provide facility guidance to Senior Leadership, aligning ... pulmonary diseases, and other orphan diseases. **How you'll contribute** The Associate Director of Facilities will establish and maintain the highest standards for… more