Associate Director, Clinical Quality Assurance
Job Title: Associate Director, Clinical Quality Assurance
Location: San Diego, CA
Company: [Confidential Biotech Company]
About the Company:
A dynamic clinical-stage biotechnology company is seeking a seasoned professional to lead Clinical Quality Assurance (CQA) efforts. This role is pivotal in ensuring that clinical operations adhere to the highest standards of quality, regulatory compliance, and continuous improvement. The company is advancing innovative therapies in the immunology and regenerative medicine space.
The Associate Director will report to the Head of Quality and will be responsible for developing and executing GCP compliance strategies across clinical programs. The role involves close collaboration with internal stakeholders and external partners to maintain audit readiness and support the implementation of robust quality systems.
Key Responsibilities:
- Oversee clinical quality activities across internal teams and external collaborators, including CROs, vendors, and investigator sites.
- Review clinical documentation for regulatory compliance and inspection preparedness.
- Manage quality events, deviations, and complaints; lead investigations and corrective/preventive actions (CAPAs).
- Interpret and apply global regulatory requirements and industry standards to clinical operations.
- Conduct audits of clinical sites, vendors, and systems to ensure compliance.
- Partner cross-functionally to align quality initiatives with clinical development objectives.
- Represent clinical quality in internal forums and contribute to SOPs, policies, and training programs.
- Identify and communicate compliance risks and propose mitigation strategies.
- Maintain and enhance quality documentation and systems.
- Monitor regulatory trends and industry developments to inform quality practices.
Qualifications:
- Bachelor's degree in life sciences or a related field.
- Minimum of 8 years of experience in clinical quality assurance within the biotech or pharmaceutical industry.
- Proven expertise in GCP compliance, vendor oversight, and quality systems.
- Strong knowledge of FDA, ICH, and ISO guidelines.
- Excellent communication, collaboration, and analytical skills.
- Proficiency in Microsoft Office tools, especially Word and Excel.
Preferred Experience:
- Background in advanced therapeutic modalities such as cell or gene therapy.
- Experience supporting regulatory inspections.
- Willingness to travel for audits and site visits.
- Authorization to work in the United States.
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