Senior Director, Clinical Quality Assurance (CQA)

Required

• Bachelor's degree in a life science, nursing, pharmacy, or related field; advanced degree (MS, PharmD, PhD) preferred.
• Experience in Ophthalmology is highly desired
• 12+ years of experience or advanced degree with 10+ years of experience within a regulated environment such as Regulatory, Quality, Pharmacovigilance or Clinical Development / Operations within the Biotech or similar Industry
• Proven experience leading Clinical quality strategy, quality governance, and senior-level quality oversight of global clinical trials and associated vendors
• Minimum of 7 years of significant experience in clinical quality assurance, including experience leading, performing, and/or providing senior oversight of GCP audits and global clinical trials.
• Experience hosting, leading, and supporting health authority inspections, including inspection readiness preparation, front-room/back-room support, response coordination, and follow-up commitment management
• Extensive practical experience and understanding of clinical quality assurance applied throughout the clinical development life-cycle
• Demonstrated ability to influence senior cross-functional stakeholders, lead complex clinical quality initiatives, and provide mentorship or functional leadership within Clinical QA
• Other Qualifications/Skills:
• Expert understanding of GCP requirements for investigational products and the ability to interpret and apply requirements strategically across clinical programs
• Executive-level communication skills, both oral and written, with ability to present quality risks, recommendations, and inspection-readiness status to senior stakeholders
• Strong leadership, influencing, and interpersonal skills, with a collaborative approach to driving alignment across Clinical, Quality, Regulatory, and external vendor stakeholders