Head of Clinical Quality Management

1 week ago


South San Francisco, California, United States GQR Full time

Position: Director of Clinical Quality Assurance

Location: South San Francisco

Employment Type: Full-time direct hire; Hybrid role 3 days a week onsite

The Director of Clinical Quality Assurance (CQA) is a pivotal role that demands a proactive approach to ensure that clinical trials comply with relevant GCP regulations (including FDA, international, and country-specific guidelines), ICH standards, Standard Operating Procedures (SOPs), and the latest industry practices. This role will be instrumental in fostering clinical compliance and maintaining inspection readiness, reporting directly to the Senior Director of CQA.

Key Responsibilities:

  • Act as the representative for clinical quality during program team meetings, offering operational quality guidance to development teams.
  • Participate in operational meetings with CROs, service providers, and vendor quality meetings to uphold clinical quality standards.
  • Oversee the quality of ongoing clinical programs, ensuring that appropriate assessments, monitoring, risk evaluations, and mitigation strategies are effectively implemented.
  • Conduct thorough reviews of clinical trial documentation to ensure data integrity and compliance with Good Clinical Practice and regulatory requirements, including essential clinical and IND/NDA enabling documents.
  • Provide clinical quality support during Health Authority Inspections, service provider meetings, and CRO operational meetings, as well as during inspection readiness activities.
  • Collaborate closely with Clinical Development (including Pharmacovigilance/Safety), Regulatory Affairs, and Development Operations (including Clinical Operations, Data Management, and Biostatistics), as well as CROs and clinical sites to ensure comprehensive GCP compliance and inspection readiness.

Qualifications:

To excel in this role, candidates must demonstrate the ability to fulfill each essential duty. The following qualifications are indicative of the knowledge, skills, abilities, and prior experience required:

  • A Bachelor's degree with a minimum of 12 years of relevant experience, or an advanced degree in a scientific discipline with at least 10 years of experience preferred. Certification in quality assurance is advantageous.
  • A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
  • A comprehensive understanding of risk-based quality systems approaches in alignment with ICH E6 (R2) for Good Clinical Practice, with experience across all phases of clinical trials.
  • Familiarity with and practical application of ICH E8 (R1).
  • Proficiency in interpreting and applying GCP, EU, FDA, and ICH regulations and guidelines, including a solid understanding of domestic and international regulatory requirements.


  • South San Francisco, California, United States GQR Full time

    Position Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that entails a hands-on approach to ensuring that clinical trials comply with relevant GCP regulations (including FDA, international...


  • South San Francisco, California, United States GQR Full time

    Position Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) plays a pivotal role in overseeing that clinical trials comply with relevant GCP regulations, including FDA guidelines, international standards, and...


  • South San Francisco, California, United States Abdera Therapeutics Full time

    Abdera Therapeutics Inc. - Director of Quality in Clinical OperationsAbdera Therapeutics Inc. is at the forefront of precision oncology, focusing on innovative radiation therapies. We are looking for a Director of Quality in Clinical Operations to oversee quality management for our cutting-edge oncology clinical initiatives.Key Responsibilities:Oversee...


  • South San Francisco, California, United States GQR Full time

    Position: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role focused on ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific guidelines), ICH standards,...


  • South San Francisco, California, United States Pliant Therapeutics Full time

    Pliant Therapeutics is a leading biopharmaceutical organization dedicated to the innovation and advancement of groundbreaking treatments for fibrotic diseases. Established by Third Rock Ventures alongside esteemed academic experts, Pliant is committed to addressing the critical medical needs of healthcare providers, patients, and families affected by...


  • South San Francisco, California, United States GQR Full time

    Position: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role that demands a proactive approach to guarantee that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific),...


  • San Francisco, California, United States Clinical Management Consultants Full time

    Job Summary: Clinical Management Consultants is seeking an experienced Nurse Manager to oversee our Case Management team. As a key member of our clinical operations team, you will be responsible for supervising and supporting case managers, developing patient care plans, coordinating discharge planning, and improving healthcare delivery.Key...


  • San Francisco, California, United States Clinical Management Consultants Full time

    We are currently recruiting a highly skilled Nurse Manager to lead our dynamic Urology team at Clinical Management Consultants. If you are a seasoned professional looking for a challenging opportunity to make a significant impact in the field of urology, we invite you to apply.Clinical Management Consultants is committed to providing innovative patient care,...


  • San Ramon, California, United States Clinical Management Consultants Full time

    Job Summary: We are seeking an experienced Pharmacy Operations Director to join our team at Clinical Management Consultants.About the Role: As a Pharmacy Operations Director, you will be responsible for leading our pharmacy team and ensuring the delivery of high-quality patient care. You will work closely with our healthcare leaders and physicians to develop...


  • San Francisco, California, United States UCSF Full time

    HEAD OF AIRWAY CLINICAL RESEARCH CENTER UNIVERSITY OF CALIFORNIA, SAN FRANCISCO The Department of Medicine, specifically within the Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, along with the Cardiovascular Research Institute (CVRI), is in search of a Head for the UCSF Airway Clinical Research Center (ACRC) for a full-time faculty role....


  • South Lake Tahoe, California, United States Clinical Management Consultants Full time

    Job SummaryClinical Management Consultants is seeking an experienced Labor & Delivery Nurse Manager to lead our team in providing exceptional patient care and clinical leadership. As a key member of our healthcare team, you will be responsible for managing staffing, scheduling, and resource allocation to ensure the highest standards of patient care.Key...


  • San Martin, California, United States Clinical Management Consultants Full time

    Job Summary:Clinical Management Consultants is seeking an experienced Obstetrics Clinical Nurse Manager to lead our team in delivering high-quality patient care. As a key member of our clinical leadership team, you will be responsible for managing staffing, scheduling, and resource allocation to ensure the highest standards of patient care.Key...


  • San Francisco, California, United States Clinical Management Consultants Full time

    Job SummaryClinical Management Consultants is seeking a highly skilled and experienced Urology Department Lead to join our team. As a key member of our organization, you will be responsible for leading a dynamic team of healthcare professionals in a fast-paced urology department.Key ResponsibilitiesLead a department with 20 direct reports, providing guidance...


  • South San Francisco, California, United States Hibio Full time

    POSITION TITLE:Senior Vice President of Quality ManagementDIVISION:Regulatory AffairsEMPLOYMENT TYPE:Full-TimeHI-Bio, Inc. is a pioneering biotechnology firm located in South San Francisco, California. Our collective mission is to revolutionize the treatment of patients suffering from severe immune-mediated disorders by creating innovative targeted therapies...


  • South San Francisco, California, United States Meet Full time

    Position OverviewThe Senior Clinical Operations Associate will collaborate closely with the Head of Clinical Operations to facilitate the effective management and oversight of clinical trials. This role involves ensuring the integrity of trial execution and data collection while working in partnership with key study sites and investigators. The Senior...


  • South San Francisco, California, United States Aligos Therapeutics Full time

    Job OverviewAbout Aligos Therapeutics:At Aligos, we are dedicated to transforming the lives of patients globally. As a prominent clinical-stage biopharmaceutical organization, our mission is to address critical healthcare needs.Founded in 2018 and publicly traded since 2020, we foster a science-driven culture that encompasses a wide range of expertise. Our...


  • South San Francisco, California, United States Aligos Therapeutics Full time

    Job OverviewAbout Aligos Therapeutics:Are you ready to contribute to groundbreaking advancements in patient care? At Aligos, a prominent clinical-stage biopharmaceutical organization, our mission is to enhance the lives of patients globally.Founded in 2018 and publicly traded since 2020, we foster a science-driven culture enriched by diverse expertise. Our...

  • Nurse Manager

    5 days ago


    San Francisco, California, United States Clinical Management Consultants Full time

    Job Summary: We are seeking an experienced Nurse Manager to oversee our Case Management team at Clinical Management Consultants.About the Role: As a Nurse Manager, you will be responsible for supervising and supporting case managers, developing patient care plans, coordinating discharge planning, and improving healthcare delivery.Key...


  • South San Francisco, California, United States GQR Full time

    Position Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that demands active engagement in ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and...


  • San Ramon, California, United States TechForcePros Full time

    Job OverviewCompany: TechForceProsIndustry: Healthcare — Pharmaceuticals — Nursing — Home Health — Case Management — Health TechnologyTechForcePros is a leading staffing and recruitment firm, renowned for our expertise in connecting exceptional talent with prominent organizations within the healthcare sector.Position: Director of Clinical Quality...