Clinical Quality Assurance Director

1 week ago

South San Francisco, California, United States GQR Full time

Position Title: Director of Clinical Quality Assurance

Location: South San Francisco

Employment Status: Full-time direct hire; Hybrid role with 3 days onsite

The Director of Clinical Quality Assurance (CQA) is a pivotal role that involves active participation in ensuring that clinical trials comply with relevant Good Clinical Practice (GCP) regulations, including FDA and international standards, as well as ICH guidelines and internal Standard Operating Procedures (SOPs). This role is essential for maintaining clinical compliance and ensuring readiness for inspections. The position reports 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 Contract Research Organizations (CROs) and service providers, ensuring quality standards are upheld.
  • Oversee the quality of ongoing clinical programs, ensuring that appropriate assessments, monitoring, and risk mitigation strategies are effectively implemented.
  • Evaluate clinical trial documentation to ensure data integrity and compliance with GCP and regulatory requirements, including critical clinical and IND/NDA enabling documents.
  • Provide support for Health Authority Inspections and contribute to inspection readiness activities involving service providers and CROs.
  • Collaborate with various departments including Clinical Development, Regulatory Affairs, and Development Operations to ensure comprehensive GCP compliance and readiness for inspections.

Qualifications:

To excel in this role, candidates must demonstrate the ability to fulfill essential duties effectively. The following qualifications are essential:

  • 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. Certification in quality assurance is advantageous.
  • A minimum of 5 years of experience in Clinical Quality Assurance or Clinical Operations.
  • Extensive knowledge of risk-based quality systems in alignment with ICH E6 (R2) for Good Clinical Practice, with experience across all phases of clinical trials.
  • Familiarity with ICH E8 (R1) and its practical applications.
  • Ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines, including a comprehensive understanding of both domestic and international regulatory requirements.

  • Clinical Quality Assurance Director

    1 week ago

    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 on-siteThe 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...

  • Clinical Quality Assurance Director

    1 week ago

    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...

  • Director, Clinical Quality Assurance Specialist

    2 days ago

    South San Francisco, California, United States GQR Full time

    Job SummaryGQR is seeking a highly experienced Director of Clinical Quality Assurance to join our team. As a key member of our organization, you will be responsible for ensuring the highest level of quality in our clinical trials.Key ResponsibilitiesRepresent Clinical Quality at Program Team MeetingsProvide operational quality guidance to development...

  • Head of Clinical Quality Assurance

    2 weeks ago

    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,...

  • Head of Clinical Quality Assurance

    1 week ago

    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),...

  • Senior Director of Clinical Quality Assurance

    2 months ago

    South San Francisco, California, United States Alumis Inc. Full time

    Alumis Inc. is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. Alumis is hiring a Clinical Quality Assurance...

  • Head of Clinical Quality Assurance

    1 week ago

    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...

  • Head of Clinical Quality Assurance

    2 weeks ago

    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...

  • Senior Director, Quality Assurance

    3 days ago

    South San Francisco, California, United States Hibio Full time

    Job SummaryWe are seeking a highly experienced and strategic Senior Director, Quality Assurance to join our team at Hibio. This role will be responsible for overseeing and participating in the development, implementation, and maintenance of quality management practices and systems to ensure compliance with internal policies, business objectives, procedures,...

  • Head of Clinical Quality Management

    1 week ago

    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...

  • Head of Clinical Quality Management

    1 week ago

    South San Francisco, California, United States GQR Full time

    Position: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role 3 days a week onsiteThe 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...

  • Head of Clinical Quality Management

    1 week ago

    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...

  • Senior Director of GCP Clinical Quality Assurance

    2 months ago

    San Francisco, California, United States Nurix Therapeutics Full time

    Exciting Opportunity at Nurix Therapeutics, Inc.Lead the enhancement and maintenance of quality systems at NurixDrive functional and cross-functional projects focused on continuous improvementCollaborate closely with various internal and external stakeholdersThis key role involves:Establishing Nurix GCP QA programs, policies, and proceduresActing as the...

  • Quality Assurance Specialist

    5 days ago

    San Francisco, California, United States Quality Chemical Laboratories Full time

    Job Summary:Quality Chemical Laboratories (QCL) is a leading pharmaceutical testing and manufacturing laboratory seeking a qualified candidate for the role of Quality Assurance Associate. This key position requires a detail-oriented individual with strong analytical skills to ensure the accuracy and completeness of laboratory reports.Key...

  • Quality Assurance Director

    5 days ago

    San Diego, California, United States Sekisui Diagnostics GmbH Full time

    About the RoleWe are seeking a highly experienced Director of Quality Assurance to join our team at Sekisui Diagnostics GmbH. As a key member of our organization, you will play a critical role in ensuring the quality and integrity of our products.Key ResponsibilitiesOversee the development, implementation, and maintenance of quality assurance systems and...

  • Director of Quality Assurance and Compliance

    13 hours ago

    San Diego, California, United States North Eastern Services Full time

    Job DescriptionDirector of Quality Assurance and ComplianceNorth Eastern Services is seeking a highly skilled and experienced Director of Quality Assurance and Compliance to join our team. As a key member of our organization, you will be responsible for ensuring the highest standards of quality and compliance across all aspects of our business.Key...

  • Director of Quality Assurance and Compliance

    1 day ago

    San Jose, California, United States BioTalent Full time

    Job Description:Director of Quality Assurance and ComplianceJob Summary:BioTalent is seeking an experienced and highly motivated Director of Quality Assurance and Compliance to lead and manage our quality systems in a dynamic and fast-paced environment. The ideal candidate will have a strong background in hosting FDA audits, obtaining ISO 13485...

  • Quality Assurance Analyst

    2 weeks ago

    South San Francisco, California, United States Planet Pharma Full time

    Position OverviewThe Quality Assurance Analyst will play a crucial role in ensuring compliance with industry standards and regulations within the quality management framework.Key ResponsibilitiesOversee daily functions of Quality Systems and Document Control to uphold regulatory compliance.Assist in the execution of projects aimed at enhancing quality...

  • Director of Quality Assurance Leadership

    5 days ago

    San Diego, California, United States Sekisui Diagnostics GmbH Full time

    About the RoleWe are seeking a highly experienced Director of Quality Assurance to join our team at Sekisui Diagnostics GmbH. As a key member of our organization, you will play a critical role in ensuring the highest standards of quality in our products and services.Key ResponsibilitiesOversee the development, implementation, and maintenance of quality...

  • Vice President, Quality Assurance and Compliance

    5 days ago

    South San Francisco, California, United States Hibio Full time

    About the RoleWe are seeking a seasoned Quality Professional to join our team at Hibio, Inc. as Vice President, Quality Assurance and Compliance. This is a critical role that will oversee and participate in the development, implementation, and maintenance of quality management practices and systems to ensure compliance with internal policies, business...