Director of Quality Assurance

8 hours ago

South San Francisco, California, United States Epic Bio Full time
Job Summary

The Director of Quality Assurance will oversee all quality aspects of the organization from Quality Assurance to Quality Control. This position requires a strong ability to organize parallel projects and work independently to develop a strong quality infrastructure. The ideal candidate will define and implement the Quality Management System (QMS), including all quality policies and procedures pertaining to the cGMP manufacturing of products for the biotechnology industry.

Responsibilities:
  • Lead and oversee the Quality function for the company, ensuring compliance with regulatory requirements and industry standards.
  • Develop and implement a comprehensive Quality strategy aligned with business objectives, regulatory requirements, and industry best practices.
  • Act as the primary GCP and GMP QA subject matter expert and point of contact for all GCP/GMP related matters and issues.
  • Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
  • Prepare, communicate, and manage budgets and goals for the Quality Assurance unit.
  • Supervise and guide internal audits of various departments/processes.
  • Write, revise, review and/or approve SOPs, controlled forms, and related documents to ensure best practices and current operations.
  • Responsible for completing the disposition of all in-process and finished products, ensuring compliance with all applicable regulations.
  • Address observations or recommendations as well as implement corrective/preventive actions as needed.
  • Prepare and approve quality agreements.
  • Ensure compliance with GMP, FDA, OSHA, and all other regulatory requirements in accordance with company policy.
  • Provide mentorship, guidance, and support to Quality Assurance and Quality Control team members, fostering a culture of learning, collaboration, and continuous improvement.
  • Drive cross-functional collaboration and alignment with other departments, such as Manufacturing, Regulatory Affairs, and Clinical Operations, to achieve quality and compliance objectives.
  • Adhere to company safety requirements. Maintains a safe and healthy work environment by establishing and enforcing organizational safety standards and adhering to legal regulations.

Qualifications

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

  • BS required, MS preferred in a scientific/technical discipline with 15+ years of experience in a quality leadership position within the biological and/or pharmaceutical industry with specific experience in cell and gene therapy preferred.
  • Significant experience supporting functional areas (e.g., PD, Manufacturing, QA, Engineering, EHS) preferred.
  • Demonstrated experience with writing/reviewing deviations, laboratory investigations, and OOS investigations. Experience with root cause analysis a plus.
  • Demonstrated experience with regulatory inspections from the FDA, EMA, Health Canada, or other regulatory authorities.
  • Solid knowledge of FDA and EMA regulatory requirements for gene therapy and cell therapy
  • Ability to apply cGMP regulations and international guidelines to all aspects of the position.
  • Ability to write reports, business correspondence, and procedure manuals.
  • Proven track record of successfully leading Quality initiatives and driving compliance in a regulated manufacturing environment.
  • Able to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
  • Ability to effectively present information to employees, top management, public groups, and/or boards of directors.
  • Strong leadership and people management skills, with the ability to inspire and develop high-performing teams.
  • Must be able to assess and utilize software and customized programs to meet QA and QC business needs.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions and levels of the organization.
  • Strategic mindset with the ability to translate business objectives into actionable Quality strategies and initiatives.

  • Director of Quality Assurance

    5 days ago

    South San Francisco, California, United States Jobot Full time

    Director of Quality AssuranceWe are seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring the highest level of quality in our...

  • Director of Quality Assurance

    5 days ago

    South San Francisco, California, United States Jobot Full time

    {"title": "Director of Quality Assurance", "description": "Job SummaryWe are seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring...

  • Director of Quality Assurance

    20 hours ago

    South San Francisco, California, United States Epic Bio Full time

    Job Title: Director of Quality AssuranceJob Summary:Epic Bio is seeking a highly motivated Director of Quality Assurance to oversee all quality aspects of the organization. This position requires a strong ability to organize parallel projects and work independently to develop a strong quality infrastructure.Key Responsibilities:Define and implement the...

  • Director of Quality Assurance

    2 weeks ago

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

    Job Title: Director of Quality AssurancePliant Therapeutics is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. As a Director of Quality Assurance, you will play a critical role in ensuring the quality and compliance of our products, from early-stage development to...

  • Director of Quality Assurance

    2 days ago

    South San Francisco, California, United States Epic Bio Full time

    Job Title: Director/Sr. Director of Quality AssuranceEpic Bio is seeking a highly motivated and experienced Director/Sr. Director of Quality Assurance to oversee all quality aspects of the organization. The ideal candidate will have a strong background in quality leadership and a proven track record of driving compliance in a regulated manufacturing...

  • Director of Quality Assurance

    2 days ago

    South San Francisco, California, United States Epic Bio Full time

    Job SummaryEpic Bio is seeking a highly motivated Director of Quality Assurance to oversee all quality aspects of the organization. The ideal candidate will define and implement the Quality Management System (QMS), including all quality policies and procedures pertaining to the cGMP manufacturing of products for the biotechnology industry. This position will...

  • Clinical Quality Assurance Director

    4 days ago

    South San Francisco, California, United States Annexon Bioscience Full time

    Job SummaryAnnexon Biosciences is seeking a highly skilled Clinical Quality Assurance Director/Senior Director to lead the company's clinical Quality Assurance (cQA) program. The successful candidate will be responsible for developing quality systems to ensure clinical trials are conducted in accordance with appropriate regulations, guidelines, procedures,...

  • Director of Quality Assurance and Compliance

    5 days ago

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

    Job Title: Director, Quality AssurancePliant Therapeutics is a leading biopharmaceutical company dedicated to the discovery and development of innovative therapies for fibrotic diseases. As a Director of Quality Assurance, you will play a critical role in ensuring the quality and compliance of our products, from early-stage development to...

  • Director of Clinical Quality Assurance

    21 hours ago

    South San Francisco, California, United States Meet Full time

    Job Title: Director of Clinical Quality AssuranceMeet is partnering with an exciting and growing Pre-IPO biotech to help find them a Director of Clinical Quality Assurance to add to their team. The position involves close collaboration with various departments, including Clinical Operations, Clinical Development, CMC, Medical Affairs, Regulatory Affairs,...

  • Medical Device Quality Assurance Director

    23 hours ago

    South San Francisco, California, United States Jobot Full time

    Job Title: Director of Quality AssuranceAbout the Role:Jobot is seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring the highest...

  • Food Safety and Quality Assurance Director

    3 weeks ago

    South San Francisco, California, United States Mac Incorporated Full time

    Job Title: FSQA DirectorJob Summary:Mac Incorporated is seeking a highly experienced FSQA Director to lead our food safety and quality assurance initiatives. As a key member of our team, you will be responsible for ensuring the highest standards of food safety and quality in our bakery operation.Key Responsibilities:Develop and implement robust quality...

  • Director of Quality Assurance Leadership

    4 days ago

    South San Francisco, California, United States Jobot Full time

    Job SummaryWe are seeking a highly experienced and dynamic leader to fill the role of Director of Quality Assurance. This is an excellent opportunity for an individual with a solid background in Quality Assurance, Compliance, and Manufacturing to lead and direct a team of professionals in ensuring the highest level of quality in our products.Key...

  • Director of Clinical Quality Assurance

    2 days ago

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

    Job DescriptionPliant Therapeutics is a leading biopharmaceutical company focused on the discovery and development of novel therapies for fibrotic diseases. We are seeking a highly skilled Director of Clinical Quality Assurance to join our team.The successful candidate will be responsible for ensuring that our clinical trials adhere to applicable GCP...

  • Food Safety and Quality Assurance Director

    7 days ago

    South San Francisco, California, United States Mac Incorporated Full time

    Job Title: FSQA DirectorJob Summary:Mac Incorporated is seeking a highly experienced FSQA Director to lead our food safety and quality assurance initiatives. As a key member of our leadership team, you will be responsible for ensuring the highest standards of food safety and quality in our manufacturing environment.Key Responsibilities:Develop and implement...

  • Associate Director of Quality Assurance

    5 days ago

    San Francisco, California, United States Kanvas Biosciences Full time

    About UsKanvas Biosciences is a pioneering biotechnology company dedicated to unlocking the full potential of the microbiome. Our mission is to harness the power of microbial interactions to develop innovative treatment strategies and improve human health.Our ValuesWe attract and retain top talent. Our team is comprised of world-class scientists who share...

  • Senior Director of Quality Assurance

    2 hours ago

    South San Francisco, California, United States Meet Full time

    Meet is seeking a highly experienced VP of Quality Assurance to lead our Quality Assurance team in San Francisco, CA. The ideal candidate will have extensive small molecule experience and a strong background in GMP QA with exposure to GLP and QC.Key Responsibilities:Develop and implement quality assurance strategies to ensure compliance with regulatory...

  • Director of Quality Assurance and Testing

    4 days ago

    San Francisco, California, United States Motorola Solutions Full time

    Job DescriptionThe Director of Quality Assurance will be responsible for overseeing the QA strategy and processes for both hardware and software products.This role requires a strategic thinker with deep expertise in quality assurance practices, experience in managing cross-functional teams, and a strong understanding of the technology landscape.The Senior...

  • Senior Director of Clinical Quality Assurance

    4 weeks ago

    San Francisco, California, United States Meet Full time

    Job Title: Senior Director of Clinical Quality AssuranceMeet the Challenge: Meet is partnering with an innovative biotech to find a Senior Director of Clinical Quality Assurance. This role demands expertise in Good Clinical Practices (GCP) and Good Pharmacovigilance Practices (GVP), along with pertinent US and EU regulations. The ideal candidate will foster...

  • Director of Quality Assurance

    3 weeks ago

    San Jose, California, United States Monolithic Power Systems Full time

    Job Title: Director of QualityJob Summary:We are seeking a highly experienced and skilled Director of Quality to lead our global Quality Assurance organization. The successful candidate will be responsible for managing our Quality Management System (QMS) and Customer Quality Engineers (CQE) teams in the US, Japan, EU, and Korea.Key Responsibilities:Develop...

  • Director of Quality Assurance and Compliance

    3 weeks ago

    San Diego, California, United States Proven Recruiting Full time

    Director of Quality Assurance and ComplianceProven Recruiting is seeking a seasoned professional to lead our Quality Assurance and Compliance team. As a Director of Quality Assurance and Compliance, you will be responsible for driving the implementation of an Electronic Document Management System (EDMS) to streamline operations, developing and executing...