Senior Director, Clinical Quality Assurance (CQA)
4D Molecular Therapeutics
September 01, 2026
Remote friendly (United States)
United States
Clinical Research and Development
Senior Director of Clinical Quality Assurance (CQA)
Responsibilities:
- Provide strategic and operational Quality Assurance leadership/oversight for multiple global, registrational 4DMT-sponsored clinical trials to ensure compliance with international GCP requirements.
- Serve as a senior quality partner to clinical teams; guide GCP/ICH E6 and support escalation of clinical study quality events.
- Lead development, implementation, and governance of Clinical Study Quality Plans to protect subject safety/rights, data integrity, and GCP compliance across studies and vendors.
- Manage, mentor, and develop Clinical QA staff/consultants; establish goals, development plans, and succession depth.
- Perform/oversee risk-based GCP compliance audits of high-risk vendors/sites (including investigator sites).
- Communicate audit findings, quality risks, and CAPA commitments; track/review/assess CAPAs and ensure timely escalation of unresolved/recurring issues.
- Provide senior quality review of key clinical/regulatory documents (e.g., protocols, IBs, DSURs, Module 2.6/2.7, integrated summaries).
- Lead/oversee investigations and management of significant clinical study quality events; provide QA oversight of CAPAs.
- Partner with CMC Quality and cross-functional teams on clinical supply quality issues (e.g., temperature excursions, product complaints, site deviations) with risk assessment and CAPA linkage.
- Drive clinical quality culture (training, continuous improvement of Clinical Quality Management system) and embed quality/risk management into study design/conduct.
- Own GCP inspection readiness strategy and readiness activities; support health authority inspections.
Qualifications:
- Bachelor’s degree in life sciences/nursing/pharmacy/related; MS/PhD/PharmD preferred.
- 12+ years experience (or advanced degree with 10+ years) in a regulated environment (regulatory, quality, pharmacovigilance, clinical development/operations) within biotech or similar.
- Proven leadership in clinical quality strategy/governance and senior oversight of global trials and vendors.
- 7+ years significant clinical QA experience, including leading/providing oversight of GCP audits and global clinical trials.
- Experience hosting/leading health authority inspections (readiness, front/back room support, response coordination, follow-up).
Skills:
- Expert understanding of GCP for investigational products; strategic interpretation/application.
- Executive-level written/oral communication; ability to present quality risks and inspection readiness status.
- Strong leadership/influencing; collaborative alignment across Clinical, Quality, Regulatory, and vendors.
- Ability to operate independently in a fast-paced, small-company environment; prioritize complex workstreams and make risk-based decisions.
Travel: ~5%.
Base salary range: $245,000–$286,000.
Responsibilities:
- Provide strategic and operational Quality Assurance leadership/oversight for multiple global, registrational 4DMT-sponsored clinical trials to ensure compliance with international GCP requirements.
- Serve as a senior quality partner to clinical teams; guide GCP/ICH E6 and support escalation of clinical study quality events.
- Lead development, implementation, and governance of Clinical Study Quality Plans to protect subject safety/rights, data integrity, and GCP compliance across studies and vendors.
- Manage, mentor, and develop Clinical QA staff/consultants; establish goals, development plans, and succession depth.
- Perform/oversee risk-based GCP compliance audits of high-risk vendors/sites (including investigator sites).
- Communicate audit findings, quality risks, and CAPA commitments; track/review/assess CAPAs and ensure timely escalation of unresolved/recurring issues.
- Provide senior quality review of key clinical/regulatory documents (e.g., protocols, IBs, DSURs, Module 2.6/2.7, integrated summaries).
- Lead/oversee investigations and management of significant clinical study quality events; provide QA oversight of CAPAs.
- Partner with CMC Quality and cross-functional teams on clinical supply quality issues (e.g., temperature excursions, product complaints, site deviations) with risk assessment and CAPA linkage.
- Drive clinical quality culture (training, continuous improvement of Clinical Quality Management system) and embed quality/risk management into study design/conduct.
- Own GCP inspection readiness strategy and readiness activities; support health authority inspections.
Qualifications:
- Bachelor’s degree in life sciences/nursing/pharmacy/related; MS/PhD/PharmD preferred.
- 12+ years experience (or advanced degree with 10+ years) in a regulated environment (regulatory, quality, pharmacovigilance, clinical development/operations) within biotech or similar.
- Proven leadership in clinical quality strategy/governance and senior oversight of global trials and vendors.
- 7+ years significant clinical QA experience, including leading/providing oversight of GCP audits and global clinical trials.
- Experience hosting/leading health authority inspections (readiness, front/back room support, response coordination, follow-up).
Skills:
- Expert understanding of GCP for investigational products; strategic interpretation/application.
- Executive-level written/oral communication; ability to present quality risks and inspection readiness status.
- Strong leadership/influencing; collaborative alignment across Clinical, Quality, Regulatory, and vendors.
- Ability to operate independently in a fast-paced, small-company environment; prioritize complex workstreams and make risk-based decisions.
Travel: ~5%.
Base salary range: $245,000–$286,000.