- BeiGene (San Mateo, CA)
- **General Description:** The Director , GCP Inspection Management , is responsible for: + Supervising activities related to inspection readiness, ... + Act as R&D Quality Delegate for the Executive Director , R&D Quality, as needed + Support development of...+ Promote continuous improvement + Provide support with the GCP Inspection Management Team for… more
- BeiGene (San Mateo, CA)
- …quality guidance, expertise and leadership to the regional Clinical Operations Americas GCP compliance team. The Director GCP Compliance collaborates ... with ICH GCP and any local regulations. + Leads the development of a GCP inspection readiness programme at a regional level in alignment with global … more
- Pfizer (Pearl River, NY)
- … readiness and providing inspection support for GCP sponsor inspection activities + CAPA management ** Inspection Coordination** This individual may ... Serving as the point of contact for Regulatory Quality Assurance related to inspection CAPA management **Quality Compliance Assessment** Plan, lead and report… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …together. **Job Description** You will act as a primary point-of-contact for R&D Quality inspection management and act as an inspection readiness ambassador, ... maintenance of a comprehensive and connected framework for continually improving inspection management , supporting R&D personnel with the readiness, preparation,… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …Qualification process, with a steady focus on continuous improvement and stakeholder management Inspection Readiness and Support: + Ensure vendors are prepared ... The Associate Director , Vendor Management , is responsible for... preparation and post- inspection follow-up. + Maintain inspection readiness documentation and records. Vendor Management … more
- Vera Therapeutics (Brisbane, CA)
- …Quality Assurance and will be responsible for developing and maintaining GMP, GLP and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations ... Title: Associate Director , Quality Assurance Location: Brisbane, CA About Us:...global quality matters. Responsibilities: * Develop and maintain Quality Management Systems in compliance with quality standards and guidelines… more
- BeiGene (San Mateo, CA)
- …Data Management , Biostats, GPS, RBQM, etc. + Support the inspection readiness activities and participate in managing regulatory health authority inspections as ... **General Description:** The Associate Director of R&D Quality Systems, Strategy, and Excellence...drive cultural change and system modernization, ensuring that quality management systems (QMS) evolve across R&D to meet industry… more
- Lilly (Indianapolis, IN)
- …bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and ... the world. **Purpose** : The Clinical Development Trial Lead (CDTL), Associate Director / Director independently leads the cross-functional study team in the… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Program Data Management Lead is responsible for leadership and overall strategic management of Programs in Clinical Data Management (CDM). This ... conduct of clinical research studies in accordance with applicable regulations, ICH/ GCP regulations and company Standard Operating Procedures (SOPs) within assigned… more
- BeiGene (San Mateo, CA)
- **General** **Description:** The Senior Director of CMO and Distribution Logistics, Clinical Supply Chain is responsible for overseeing the Clinical Supply Chain ... leadership over the DP Supply Planning, CMO operation and Distribution management . Ensures organization effectively manages vendor relationships and activities and… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …and resources to assigned groups, including - data, reporting, training, audit, inspection , risk assessment and deviation/ CAPA management support. You may ... to assigned R&D programs. + Collaborates with the Audit, Inspection and CAPA Management Team within R&D...requirements. **This position will be filled at the Associate Director or Senior Manager level, based on experience of… more
- Takeda Pharmaceuticals (Boston, MA)
- …and regulatory requirements and expectations. + Drive the implementation and change management of processes and systems across CPMQ + Create mechanism to monitor ... and implementation of functional processes and systems + Create and implement change management plans for new and revised CPMQ processes and systems. + Manage the… more
- ICON Clinical Research (Boston, MA)
- Director , Quality- ISO13485 ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment ... to join us on our mission to shape the future of clinical development. ** Director , Quality** **- ISO13485** We are currently seeking a Director Quality Assurance… more
- Bristol Myers Squibb (Princeton, NJ)
- …by leveraging internal and external best practices and exploring technologies. The Associate Director (AD), Informed Consent Management role reports to the ... Director of Informed Consent Management . The AD will be responsible for informed consent...cross functional mindset of Quality Excellence, Quality by Design, Inspection Readiness at all times, and Growth Mindset. +… 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 through ... An excellent verbal and written communicator with robust project management skills + A goal-oriented team player who can...senior leaders, with all applicable GxP regulations, including GMP, GCP , and GLP + Establish key quality system metrics… more
- CSL Behring (King Of Prussia, PA)
- …Global R&D Quality Management with hosting and/or facilitating regulatory agency inspection . 5. Provide GCP and GxP working consultancy and other Clinical ... the Global CQA Quality System elements in the assigned compliance area including Management of CAPAs and Deviations, Inspection Preparation and Management ,… more
- MD Anderson Cancer Center (Houston, TX)
- …execution. **DATA MANAGEMENT & EDUCATION** Works closely with CRG Managers and CRG Director in the development of novel data management tools to improve data ... trial data activities for the department. This position provides leadership and management of the Data Team to ensure clinical research is conducted efficiently,… more
- CSL Behring (King Of Prussia, PA)
- …role from others (2 - 3 sentences). The purpose of the position of Executive Director R&D Quality is to lead a dedicated team responsible for quality oversight for ... the entire R&D organisation through use of the quality management system and associated processes. This role is responsible...Responsibilities cover the entire R&D GxP spectrum - GLP, GCP , GCLP, GVP and GMP as well as medical… more
- PCI Pharma Services (Lyndon, IL)
- …entrances and exits. + Assist in writing security related policies. + Maintain inspection reports and records and advises management of deficiencies and ... security reports as necessary. + Issue security violation citations as required by inspection and according to policy. + Respond to building environmental, fire and… more
- Pfizer (New York, NY)
- **ROLE SUMMARY** The Late-Stage Clinical Scientist (non-MD, Director ) is responsible for scientific oversight, data integrity and quality of clinical trial(s) in ... in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. + Authors protocols,… more