Director Of Clinical Quality

Job Description The Director of Quality Assurance provides strategic and operational leadership for Quality Assurance across the biopharma company's multitherapeutic, multinational infectious disease development programs. This role is responsible for designing, implementing, and overseeing robust global quality systems that ensure compliance with FDA, ICH, GLP, GCP, and GMP requirements. Working closely with executive leadership, Regulatory Affairs, Quality partners, CMOs, and external consultants, this position ensures comprehensive quality oversight across development, manufacturing, testing, and productrelease activities. The Director leads internal teams and external vendors, supports regulatory submissions and inspections, and drives continuous improvement of quality systems to enable successful regulatory approvals and commercialization. Primary Duties and Responsibilities -Provide overarching QA leadership for multitherapeutic, multinational development programs. -Oversee quality systems in collaboration with the CEO, Quality groups, the company's CMO, Clinical Operations, GMP staff, and external consultants. -Develop project and budget plans, define team structures, and establish Quality Assurance and Clinical Quality Plans while initiating quality systems across functions. -Build Quality Assurance programs aligned with regulatory expectations and the stage of product development. -Partner with Regulatory Affairs to support preparation of CMC sections for INDs, CTAs, and IMPDs. -Ensure compliance with applicable regulations and internal policies, including FDA, ICH, and company procedures. -Select, oversee, and audit contract vendors to ensure compliance throughout product development. Conduct internal and external audits in accordance with GLP, GCP, GMP, and quality system requirements. -Provide QA oversight of development, manufacturing, validation, testing, and productrelease activities. -Prepare documentation and train staff for preapproval and regulatory inspections. -Conduct assessments, gap analyses, and qualitysystem improvements to support successful regulatory outcomes. -Train staff in regulatory and compliance procedures. -Oversee, review, and approve internal controlled documents, including sponsor SOPs and associated training. -Ensure CRO and studysite activities comply with sponsor SOPs and documentation standards. -Approve clinical trial material (IP) labeling for U.S. and global studies; coordinate proposals, review, and ordering of packaged and labeled IP with external vendors. Supervisory Responsibilities -Manage external consultants supporting the biopharma company's Quality Assurance function, including direction, coordination, and performance evaluation in accordance with organizational policies. Job Type & Location This is a Contract position based out of San Diego, CA. Pay and Benefits The pay range for this position is $96.00 - $115.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a hybrid position in San Diego,CA. Application Deadline This position is anticipated to close on Mar 13, 2026. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email for other accommodation options.

Created: 2026-03-06