- Unknown (Weston, MA)
- …development programs and studies, including budgeting, financial oversight, and ensuring GCP compliance . This leadership position involves close collaboration ... with key investigators and thought leaders, managing internal staff and external consultants, and maintaining relationships with CROs. The Head of Clinical Operations will also be responsible for the development of the clinical operations infrastructure,… more
- Unknown (Washington, DC)
- …activities meet the necessary quality standards and that the company is in compliance with all GCP and governmental regulations. The successful candidate will ... advanced degree preferred, and at least 15 years of GCP CQA experience in the pharmaceutical industry. A minimum...required, along with a strong background in QMS and compliance systems. The ideal candidate will have a deep… more
- Unknown (Cambridge, MA)
- …responsibilities for the Executive Director include providing enterprise governance and oversight of GCP , GVP, GLP, and GCLP compliance , defining and executing a ... includes serving as the most senior QA leader across GCP , GLP, GCLP, and GVP, and ensuring end-to-end regulatory..., GLP, GCLP, and GVP, and ensuring end-to-end regulatory compliance , scientific integrity, and patient safety. The role demands… more
- Unknown (San Francisco, CA)
- …bioanalytical assay platforms. The ideal candidate will have a strong background in GCP , GLP, and GCLP compliance , and experience in supporting biomarker ... operations for registrational studies and regulatory filings. Exceptional organizational, communication, and stakeholder engagement skills are also a must. Hiring Manager Title Head of Biomarkers and Clinical Pharmacology, WCH Travel Percent Less than 10%… more
- Unknown (Oklahoma City, OK)
- …(MS, PhD, PharmD, or MD is preferred) and a deep understanding of regulatory compliance requirements, including GLP, GCP , and ICH guidelines. The candidate must ... be proficient in project management and budgeting, and willing to travel as required. The company is dedicated to revolutionizing cancer treatment and is looking for a dynamic and experienced individual to play a pivotal role in this mission. Travel Percent… more
- NY CREATES (Albany, NY)
- …the strategic convergence of authentication, authorization, privileged access, and compliance workflows across research labs, semiconductor cleanrooms, HPC clusters, ... cloud workloads (AWS, Azure, GCP ), OT/ICS environments, and federated partner ecosystems. With elite...Employer, including individuals with disabilities and protected veterans. In compliance with the Americans with Disabilities Act (ADA), if… more
- Unknown (New York, NY)
- …the organization's compliance with the highest standards, including GMP, GLP, GCP , GPV, and CSV. This role involves the oversight of GXP, data integrity, ... various entities, and the maintenance of efficient systems and processes to ensure compliance with regulatory requirements. The VP of Quality Assurance will also be… more
- Unknown (Redwood City, CA)
- …functions, including project teams, clinical development, R&D, regulatory, legal, compliance , and commercial. Responsibilities include the development of clinically ... the delivery of high-quality, scientifically accurate medical communications in compliance with established guidelines. Applicants must have a doctoral level… more
- Unknown (San Antonio, TX)
- …of scientific reports and presentations, as well as ensuring regulatory compliance and contributing to safety monitoring and risk management. Applicants for ... work effectively in a cross-functional team environment. Knowledge of Good Clinical Practice ( GCP ) and experience in asthma and/or COPD are highly desired. The ideal… more
- Unknown (Austin, TX)
- …these studies are conducted within aggressive timelines, on budget, and in full compliance with all relevant regulatory guidelines. This role involves leading a team ... preferred. The ideal candidate will have an excellent understanding of FDA guidelines, GCP , ICH, and applicable SOPs, and a proven track record in recruiting,… more
- Unknown (Mechanicsburg, PA)
- …India-based operations. Strong knowledge of cloud technologies including AWS, Azure and GCP , IT service management, and modern support operations. Proven ability to ... to balance strategic thinking with hands-on operational leadership. Familiarity with compliance frameworks (SOC 2, ISO 27001, etc.). Compensation. This role is… more
- Unknown (New York, NY)
- …managing multi-cloud Platform-as-a-Service (PaaS) solutions, with a focus on AWS, Azure, and GCP . This role requires a visionary leader and hands-on builder who can ... management, DevOps, containerization, and a strong awareness of cloud security and compliance best practices are preferred. The ideal candidate will have a… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **ABOUT THE ROLE** The Associate Director, GCP Audit & Compliance provides strategic quality oversight to clinical, ... (or equivalent). + Minimum 15+ years of experience in GCP /GCLP/GVP Quality or Compliance within the pharmaceutical industry. + Advanced understanding of global… more
- ThermoFisher Scientific (Greenville, NC)
- …Standard (Mon-Fri) **Environmental Conditions** Office **Job Description** **Job Summary** As the GCP Compliance and Process Lead at Thermo Fisher Scientific, ... + Solid knowledge of drug development, clinical trial management, and/or GCP compliance processes + Proven awareness of sponsor oversight requirements… more
- BeOne Medicines (San Mateo, CA)
- …and simplify complex systems. Highly effective in analytical and strategic assessment of GCP compliance risks; able to articulate potential business impact. + ... matter expert or reviewer of initiatives and solutions to ensure compliance with ICH GCP , applicable laws and regulations and consistency within BeiGene Quality… more
- Ford Motor Company (Dearborn, MI)
- …IAM, etc.). + Build big data solutions, ensure the guardrails, security and compliance of our GCP environment, Strong knowledge of Cloud security standards ... Ford's highly complex global infrastructure environment across Google Cloud Platform ( GCP ), on-premises data centers, and distributed locations in all major regions.… more
- Takeda Pharmaceuticals (Boston, MA)
- …Management and Statistics, with at least 3 years of experience in GCP Quality/ Compliance . + Advanced knowledge of pharmaceutical development, medical affairs ... the role:** The Associate Director, Clinical & Quality Process Compliance is responsible for ensuring the quality of processes...and GCP /GVP regulations including FDA, EU, MHRA, PMDA and ICH.… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …development of global quality improvement initiatives. + **Training & Guidance** : Provide GCP compliance training and guidance to internal teams and external ... and reporting on global audits to ensure **Good Clinical Practice ( GCP ) compliance ** across Contract Research Organizations (CROs), clinical laboratories,… more
- Parexel (Richmond, VA)
- …serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH- GCP compliance issues to Local Management and/or Clinical Quality Management ... monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines such as ICH- GCP… more
- System One (Diamondhead, MS)
- …+ Supervise sub-investigators, research coordinators, and clinical staff to ensure GCP compliance . + Oversee investigational product management, including drug ... This PRN role ensures that all study activities are performed in compliance with ICH- GCP , FDA, and institutional standards, prioritizing participant safety,… more
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