We have other current jobs related to this field that you can find below

  • Clinical Quality Assurance Director

    7 hours 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...

  • Associate Director, Clinical Quality Assurance

    3 months ago

    South San Francisco, United States Remegen Biosciences, Inc. Full time

    Job DescriptionJob DescriptionORGANIZATIONRemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein...

  • Clinical Quality Assurance Director

    3 hours 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

    4 weeks ago

    South San Francisco, United States GQR Full time

    Title: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...

  • Director, Clinical Quality Assurance

    4 weeks ago

    South San Francisco, United States GQR Full time

    Title: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...

  • Clinical Quality Assurance Director

    1 day 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 involves active participation in ensuring that clinical trials comply with relevant Good Clinical Practice (GCP) regulations,...

  • Associate Director/ Director GCP, Clinical Quality Assurance

    1 week ago

    South San Francisco, United States Pliant Therapeutics Full time

    The client is a biopharmaceutical company in the late stages of development, dedicated to discovering and creating innovative treatments for fibrotic diseases. As a leading force in the development of novel therapies for fibrotic diseases, the client focuses on creating small molecule drug candidates specifically designed to target and influence the fibrotic...

  • Head of Clinical Quality Assurance

    5 days 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,...

  • Director, Clinical Quality Assurance

    2 months ago

    South San Francisco, United States Abdera Therapeutics Full time

    Job DescriptionJob DescriptionWho we are Abdera Therapeutics Inc. is a precision oncology company developing next-generation targeted radiation therapies- one of the most cutting-edge and highly promising areas of drug development. The company is built on a proprietary modular technology platform optimized for the delivery of radioisotopes to selectively...

  • Head of Clinical Quality Assurance

    3 hours 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...

  • Senior Director of Clinical Quality Assurance

    2 months 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...

  • Senior Director of Clinical Quality Assurance

    2 months 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...

  • Head of Clinical Quality Assurance

    6 hours 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

    6 days 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...

  • Director, Quality Assurance

    1 week ago

    South San Francisco, United States GQR Full time

    Title: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...

  • Director, Quality Assurance

    1 week ago

    South San Francisco, United States GQR Full time

    Title: Director, Quality Assurance (Drug Substance)Location: South San Francisco, CAHybrid: 3-4 days a week onsiteCompensation: Annual Salary of $230,000Annual bonus of 20%plus equity in shares of optionsWe are seeking an experienced professional to join our team as Director, of Quality Assurance.This role will provide oversight of drug substance contract...

  • Associate Director Quality Assurance

    1 week ago

    San Mateo, United States ACL Digital Full time

    Job Title: Associate Director, Functional Quality Business Partners, Medical Devices, R&D Quality Location: Foster City CADuration: 12 MonthsDescription:Job: Associate Director, Functional Quality Business Partners, Medical Devices, R&D Quality (Foster City, CA)Would you like to play a crucial role in developing life-saving therapies? Are you excited to use...

  • Associate Director Quality Assurance

    1 week ago

    San Mateo, United States ACL Digital Full time

    Job Title: Associate Director, Functional Quality Business Partners, Medical Devices, R&D Quality Location: Foster City CADuration: 12 MonthsDescription:Job: Associate Director, Functional Quality Business Partners, Medical Devices, R&D Quality (Foster City, CA)Would you like to play a crucial role in developing life-saving therapies? Are you excited to use...

  • Head of Clinical Quality Management

    7 hours 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...

Associate Director, Clinical Quality Assurance

2 months ago

South San Francisco, United States Remegen Biosciences, Inc. Full time
Job DescriptionJob DescriptionORGANIZATION

RemeGen Biosciences is a biopharmaceutical company, focusing on the discovery and development of innovative medicines for the treatment of cancer and autoimmune diseases, based in South San Francisco, California, and Rockville, Maryland. By leveraging our deep insights into oncology and immunology, advanced protein engineering/design technologies, and extensive knowledge in clinical development, our vision is to uncover the novel therapeutic targets and develop the best-in-class and first-in-class biotherapeutics for the patients with significant unmet medical needs. RemeGen Bioscience is a wholly owned subsidiary of RemeGen Co., Ltd. a global pharmaceutic company specialized in autoimmune, oncology and ophthalmic diseases.

POSITION SUMMARY

As the Clinical Trial Quality Assurance Associate Director you will provide strategic leadership and oversight to ensure the highest levels of quality, compliance, and integrity throughout our clinical trial programs. You will collaborate closely with cross-functional teams and senior management to establish and maintain a culture of quality excellence while aligning with regulatory requirements and industry best practices. This is a remote role open to candidates in Massachusetts, Pennsylvania, South Carolina, and Texas.

KEY RESPONSIBILITIES
 
  • Develop and execute a strategic vision for the clinical trial quality assurance program, encompassing Good Clinical Practice (GCP) guidelines, quality standards, and regulatory compliance.
  • Establish and maintain a risk-based approach to quality assurance, conducting risk assessments, and implementing mitigation strategies.
  • Provide expertise in GCP compliance and interpretation to all clinical development programs.
  • Oversee the planning and execution of program specific risk-based audits (routine and for cause), inspections, and assessments of clinical trial activities, documents, and systems.
  • Lead investigations into quality issues and root cause analysis thereby ensuring appropriate CAPA are developed and completed in a timely manner.
  • Oversee and manage the auditing and qualification process for clinical trial vendors.
  • Serve as the primary point of contact for regulatory agency interactions and inspections, ensuring compliance with all regulatory requirements.
  • Collaborate closely with cross-functional teams, including clinical development/operations, regulatory affairs, clinical supply management, data management, and medical affairs, to drive quality improvements across all clinical trial processes.
  • Review and approve Standard Operating Procedures (SOPs) related to clinical trial quality assurance and ensure their alignment with regulatory guidelines.
  • Keep abreast of evolving industry trends, regulatory changes, and best practices, and provide strategic guidance to the organization.
  • Participate in or lead GCP related training efforts within the department.
  • Champion a culture of quality, ethics, and continuous improvement within the company.

REQUIREMENTS
 Education:
  • Bachelor’s degree in relevant scientific discipline, required.
  • Master’s degree preferred.
  • Professional certifications related to quality assurance (e.g., RQAP-GCP, CQA) are a plus.
Experience:
  • Minimum of 7 years of experience in clinical trial quality assurance within the biotech, pharmaceutical, or CRO industry.
  • Expert knowledge of GCP guidelines, FDA regulations, and ICH standards pertaining to clinical trials.
  • Proven experience conducting quality audits, inspections, and preparing for regulatory agency interactions.
  • Experience with electronic document management systems and quality management software.
Skills:
  • Strong leadership, strategic thinking, and decision-making skills.
  • Strong analytical skills with the ability to identify trends, patterns, and potential areas of improvement.
  • Ability to maintain accuracy and quality under tight deadlines.
  • Leadership skills with the ability to mentor and guide junior staff in quality assurance practices.
  • Excellent written and verbal communication skills.
  • Ability to work cross-functionally in a fast-paced, collaborative environment.
  • Strong attention to detail and problem-solving skills.

OTHER
 Supervisory Responsibilities:None.
 Equipment To Be Used:Laptop computer, other office equipment, and/or lab equipment.
 Typical Physical Demands:Manual dexterity sufficient to operate standard office equipment.
 Working Conditions:Works remotely. Occasionally called upon to work hours in excess of your normal daily schedule. Up to 10% travel as needed.
BENEFITS
 Benefits:
  • 401(k) and matching program
  • Medical, Vision, and Dental Insurance
  • Flexible Spending Account
  • Short- and long-term disability
  • Life insurance
  • Employee Assistance Program
  • Employee discounts
  • Paid time off/vacation/sick time
  • Professional development assistance
  • Referral program

RemeGen Biosciences is an Equal Opportunity Employer. RemeGen Biosciences’ success depends heavily on the effective utilization of qualified people, regardless of their race, ancestry, religion, color, sex, age, national origin, sexual orientation, gender identity and/or expression, disability, veteran’s status, or any other characteristic protected by the law. As a company, we adhere to and promote equal employment opportunity (EEO) for all.

Must be able to work legally in the United States without sponsorship from employer.
 

Powered by JazzHR

ZmROcCUxcD