Director, GCP Quality Assurance

Electra Therapeutics, based in South San Francisco, California, is a clinical stage biotechnology company developing therapies that target signal regulatory proteins (SIRP) for the treatment of immunological diseases and cancer.

We are seeking a Director, GCP Quality Assurance (QA) to lead our global GCP and Pharmacovigilance (PV) quality strategy. This individual will provide strategic direction and oversight of clinical QA activities across all phases of clinical development. The Director will be a key advisor to leadership, shaping the company’s GCP/PV compliance strategy, fostering inspection readiness, and embedding a culture of quality and operational excellence across the clinical organization and with our external partners.

Reporting to the Head of Quality Assurance, the Director will drive proactive risk management, continuous improvement, and regulatory preparedness across our development portfolio. This role is critical to maintaining regulatory compliance and ensuring patient safety in support of our mission to deliver high-quality clinical programs.

KEY RESPONSIBILITIES: 

• Lead risk-based GCP and PV QA oversight for clinical trials from first-in-human through marketing authorization ensuring compliance with global regulatory requirements while enabling operational flexibility.
• Partner with Clinical Development, Clinical Operations, Pharmacovigilance, and Regulatory teams, providing compliance guidance and support for clinical execution, trial design, protocol development, and vendor selection.
• Implement and maintain a risk-based audit program covering clinical sites, vendors, internal systems/processes, and GCP/PV service providers.
• Manage and/or conduct GCP and PV audits, including oversight of corrective and preventive actions (CAPAs).
• Provide leadership in preparing for and managing regulatory inspections and inspection strategies.
• Contribute to the development, review, and improvement of GCP/PV policies, SOPs, and other quality system documents.
• Ensure quality systems and processes are in place to safeguard the rights, safety, and well-being of clinical trial participants.
• Collaborate cross-functionally with internal stakeholders and external partners to support a strong culture of GCP and PV compliance.
• Monitor quality trends, deviations, and risk indicators. Present actionable insights and quality performance updates to senior leadership.

EDUCATION & PROFESSIONAL EXPERIENCE:

• Bachelor’s or advanced degree in Biology, Chemistry, Chemical Engineering, or related scientific field.
• Minimum 10 years of experience in the biopharmaceutical industry with a strong focus on GCP Quality Assurance, ideally gained within a small biotech or pharmaceutical company.
• Direct experience supporting biologics development programs.
• Proven track record of leading GCP QA strategy and operations across all phases of clinical development.
• Demonstrated experience preparing for, hosting, and managing global regulatory authority inspections (e.g., FDA, EMA, MHRA, PMDA).
• Extensive experience conducting and overseeing internal and third-party GCP quality audits, with strong expertise in issue management and CAPA oversight within clinical trial environments.
• In-depth knowledge of ICH GCP, global regulatory requirements, and industry best practices
• Experience building and maintaining quality systems, policies, and SOPs to support GCP and PV compliance.
• Strong leadership skills with the ability to influence and collaborative effectively across functions and with external partners/vendors.
• Excellent communication and presentation skills with experience engaging senior leadership and cross-functional stakeholders.
• Ability to balance strategic thinking with hands-on execution in a dynamic, fast-paced environment.

The salary range for this position is $210,000 - $240,000. Base salary compensation is determined by a range of factors, including but not limited to candidate experience, qualifications, location and more.