Senior Director Clinical QA

3 weeks ago

South San Francisco, United States Planet Pharma Full time

This position will be a direct-hire (permanent) position with our Biotech client. This will be Hybrid, 2-3 days per week onsite at their Corporate Headquarters in South San Francisco, CA (this is required/firm).


To be considered, candidates must have expertise in CLINICAL GCP Quality Assurance. This is not a GMP role. They must have a good job history within the sponsor side of the pharma/biotech industry.


Position Summary

We're seeking a Quality Assurance (QA) Director/Senior Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols.


The incumbent is also responsible for developing specific internal procedures, training of staff, and hosting regulatory inspections. The position involves managing clinical quality operations and liaison of clinical quality related issues with the company's functional areas. The candidate will perform audits of service providers, study sites, and internal processes.


The successful candidate must have the ability to execute QA tasks independently; effectively represent QA in a GCP focused team setting and manage quality related activities related to clinical vendors, investigator sites and regulatory agencies. In addition, the candidate must actively manage an appropriate level of inspection readiness of the company's clinical stakeholders and act as a catalyst for continuous process improvement.


Responsibilities

  • Provide Clinical Quality Assurance (GCP) strategic and technical leadership and Subject Matter Expertise (SME) to clinical study teams; Partner with the teams to effect appropriate and timely documentation of quality event management, including CAPA plans in support of the product pipeline.
  • Plan and oversee activities in support of regulatory submissions and inspections; Lead GCP Inspection Readiness efforts, ensure implementation and prepare internal and external teams for Pre-Approval Inspections (PAI).
  • Implement, monitor, and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA and EU regulations/directives/requirements and ICH guidelines
  • Develop and implement the appropriate suite of Standard Operating Procedures (SOPs), quality manuals, policies, and other related quality documents. Ensure that these systems are effectively communicated, understood, and followed by relevant stakeholders.
  • Create and implement clinical quality risk management strategies to identify, assess, and mitigate risks associated with clinical operations. This involves conducting risk assessments, developing risk mitigation plans, and overseeing their implementation.
  • Build training curricula based on the key elements of the Quality System; Provide leadership and oversight for training programs related to clinical quality assurance. Ensure that employees and relevant stakeholders receive appropriate training on quality standards, regulations, and procedures.
  • Establish and monitor quality metrics and key performance indicators for the effectiveness of clinical quality assurance activities. Prepare regular reports and presentations for senior/executive management highlighting quality performance, trends, and areas for improvement.
  • Collaborate with cross-functional teams, including clinical operations, regulatory affairs, pharmacovigilance, and other relevant departments, to ensure alignment and integration of clinical quality assurance activities. Build and maintain effective relationships with internal and external stakeholders, including regulatory agencies and service providers.
  • Perform internal and external audits to ensure stakeholder system compliance with existing policies and procedures, and GCP requirements, standards, and guidelines.
  • Assist with tracking GCP compliance audit trends and group metrics and presenting metrics driven data to upper management.
  • Lead and/or manage additional Clinical Quality Assurance (GCP) initiatives or programs as needed.


Key Qualifications

  • Undergraduate or graduate degree(s) in Pharmaceutical Sciences, Chemical Engineering, or related discipline with at least 10 years of experience in clinical quality assurance in biotechnology and/or pharmaceutical industry. Experience working in biologics is strongly preferred
  • Current and strong working knowledge interpretation/implementation of United States Code of Federal Regulations, ICH Guidelines and other local government regulatory requirements governing clinical research.
  • Expertise in creating and executing audit plans outlining all service providers (vendor) audits, clinical investigator site audits, CSV audits and process audits.
  • Advanced knowledge of Quality Assurance principles, concepts, industry practices, and standards.
  • Excellent verbal and written communication skills, ability to lead cross-functional teams and independently prioritize work, manage multiple projects while maintaining quality and being an advocate for quality and regulatory compliance.
  • Position requires a highly diplomatic, and tactful individual with excellent critical reasoning skills.
  • Fastidiously detail-oriented and organized, impeccable attention to data QC.
  • Ability to deal with ambiguity and use expertise and skills to contribute to the development of company objectives and principles, and to achieve goals in creative and effective ways.
  • Must be flexible and able to multitask, prioritize, meet deadlines in a fast-paced environment, and be adaptable to setbacks.

  • Director/Senior Director, Clinical Quality Assurance

    4 weeks ago

    South San Francisco, United States Annexon Full time

    Work Location Corporate Headquarters (South San Francisco, CA) – Hybrid Position Summary Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with...

  • Director/Senior Director, Clinical Quality Assurance

    1 month ago

    South San Francisco, United States Annexon, Inc. Full time

    Work Location Corporate Headquarters (South San Francisco, CA) – Hybrid Position Summary Annexon Biosciences seeks a Quality Assurance (QA) Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with...

  • Director/Sr. Director, Clinical Quality Assurance

    3 weeks ago

    South San Francisco, United States Planet Pharma Full time

    Position Summary Our client seeks a Quality Assurance (QA) Director/Senior Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also...

  • Director/Sr. Director, Clinical Quality Assurance

    1 week ago

    South San Francisco, United States Planet Pharma Full time

    Position Summary Our client seeks a Quality Assurance (QA) Director/Senior Director to lead the companys clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also...

  • Director/Sr. Director, Clinical Quality Assurance- 608678

    3 weeks ago

    South San Francisco, United States Planet Pharma Full time

    Position SummaryOur client seeks a Quality Assurance (QA) Director/Senior Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols.The incumbent is also...

  • Director, Clinical Quality Assurance

    4 weeks ago

    South San Francisco, 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...

  • Director, Clinical Quality Assurance

    1 month 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...

  • Director, Clinical Quality Assurance

    4 weeks ago

    South San Francisco, United States Alumis Full time

    Job DescriptionJob DescriptionSalary: 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...

  • Director/Senior Director, Clinical Operations

    1 month ago

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

    Work LocationCorporate Headquarters (South San Francisco, CA) Onsite - Hybrid Position SummaryThis position reports into the Vice President of Global Clinical Operations. The Director/Sr. Director will contribute to the development and implementation of clinical studies. Responsibilities include providing leadership to staff and study teams to ensure...

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position: At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the future of...

  • Associate Director, QA Computer System Validation

    2 weeks ago

    South San Francisco, California, United States Cytokinetics Full time

    Provide leadership and oversight for implementation of Gx. P computer system validation lifecycle and related QA-CSV strategies Actively support the CSV functional strategies and multi-year roadmap, and actively take part in developing parts of the s QA, Validation, Director, Computer, Associate, Practice, Technology

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position: At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the future of...

  • Director/Sr. Director, Clinical Quality Assurance

    2 weeks ago

    San Francisco, United States Planet Pharma Full time

    Position Summary Our client seeks a Quality Assurance (QA) Director/Senior Director to lead the company’s clinical Quality Assurance (cQA) program. The incumbent will assist in the development of quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures, and protocols. The incumbent is also...

  • Senior Director, Clinical Pharmacology

    1 month ago

    South San Francisco, California, United States Maze Therapeutics Full time

    The Position:At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the future of...

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role...

  • Senior Director, Clinical Pharmacology

    1 month ago

    South San Francisco, United States BioSpace Full time

    Job DetailsThe Position: At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the...

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    Job DescriptionJob DescriptionThe Position:At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role...

  • Senior Director, Clinical Pharmacology

    4 weeks ago

    South San Francisco, United States Maze Therapeutics Full time

    The Position:At Maze Therapeutics, we are assembling a team of passionate, creative, and dedicated professionals to join us on our mission to turn groundbreaking genetic discoveries into life-saving medicines. We're looking for a Senior Director, Clinical Pharmacology to join our Clinical Science team and take a central role in pioneering the future of...

  • Senior Director GCP Quality Assurance

    2 weeks ago

    South San Francisco, United States Meet Full time

    My client is an exciting biopharmaceutical company advancing therapies for classical complement-mediated neuroinflammatory diseases. They are are seeking a Quality Assurance Director/Senior Director to lead their clinical Quality Assurance (cQA) program. This role involves developing and managing quality systems to ensure clinical trials comply with...

  • Senior Director GCP Quality Assurance

    2 weeks ago

    South San Francisco, United States Meet Full time

    My client is an exciting biopharmaceutical company advancing therapies for classical complement-mediated neuroinflammatory diseases. They are are seeking a Quality Assurance Director/Senior Director to lead their clinical Quality Assurance (cQA) program. This role involves developing and managing quality systems to ensure clinical trials comply with...