**PURPOSE**
Serve as an integral member of the Quality team by providing quality assurance oversight and leadership for operations, manufacturing, and quality control activities. Ensure alignment with systems quality terms, regulatory requirements, and Genezen quality policies and procedures. Support the development of QA staff and teams.

**ESSENTIAL JOB FUNCTIONS / DUTIES**
– Assist in maintaining quality systems, including a strong and continuous quality improvement program that complies with GMP and is appropriate for cell and gene therapy products used in early-phase clinical trials.
– Act as a Quality Subject Matter Expert, delivering training, oversight, collaboration, and approval for all Quality Management System activities and deliverables, including but not limited to electronic change control, quality events, deviation investigations, and CAPAs within Veeva Vault QMS.
– Develop and prepare quality management system metrics for the Quality Management Review.
– Support the preparation, execution, and follow-up of regulatory inspections and client audits.
– Review and approve validation protocols, executed validation packages, and summary reports.
– Serve as a quality partner to client technology transfer teams to successfully onboard new clients and new projects, including materials, suppliers, equipment, processes, master records, and other required support.
– Support internal and external (supplier) audit programs as a qualified auditor, including writing audit reports and tracking corrective actions and commitments.

**SPECIAL JOB REQUIREMENTS**
– Flexibility is required, as the work schedule may change based on business needs.
– Criminal background check and drug screening are required.
– Perform other duties as assigned.

**KNOWLEDGE, SKILLS & EXPERIENCE**

**EDUCATION / CERTIFICATIONS / LICENSES**
– **Essential:** Bachelor’s degree in science or a related field.
– **Essential:** In-depth knowledge of cGMP FDA and EU regulations, and ICH guidelines.
– **Essential:** Familiarity with regulatory guidance for early-phase clinical trials.
– **Essential:** Certified Quality Auditor or Certified Pharmaceutical GMP Professional.
– **Desired:** (Not specified)

**ON-THE-JOB EXPERIENCE**
– **Essential:** Minimum of 3–5 years of experience in Pharma, Biologics, or CGT within a Quality Assurance role.
– **Essential:** Experience reviewing and approving quality system reports (deviations, CAPA, change control).
– **Desired:** Experience reviewing validation protocols and reports.
– **Desired:** Experience with product/process technology transfer.
– **Desired:** Experience in Gene Therapy.
– **Desired:** Experience working in a fast-paced CDMO.

**SKILLS / ABILITIES**
– Manage multiple projects, set priorities, and work effectively in a fast-paced environment.
– Communicate confidently and effectively with management, peers, and key stakeholders.
– Demonstrate effectiveness in completing tasks, making decisions, empowering others, and solving problems.

**PHYSICAL DEMANDS**
– **Work Environment:**
– Occasionally exposed to loud noise levels.
– Role may be a combination of remote and on-site work.
– Regularly requires sitting for extended periods.
– **Movement:**
– Frequently stand; sit; use hands to finger, handle, or feel; and reach with hands and arms.
– Occasionally walk; climb or balance; and stoop, kneel, crouch, or crawl.
– **Lifting:**
– Frequently lift and/or move up to 10 pounds.
– Occasionally lift and/or move up to 25 pounds.
– **Vision:**
– Frequently uses close vision and adjusts focus.
– **Communication:**
– Frequently communicates by talking, hearing, and using telephone and email.