Head, QA Ops and Compliance (Associate Director Level)

Job Description Summary The Head, QA Ops and Compliance (Associate Director Level) provides strategic and hands‑on leadership for Quality Assurance within the Small Molecule Operations division, ensuring excellence in cGMP compliance, regulatory execution, and quality oversight across all operational activities. This role leads and develops Quality Assurance Managers, partners closely with manufacturing and external suppliers, and ensures that all products, manufactured on site, by external partners, or imported, are released to market in full alignment with Novartis Quality Standards, policies, and global regulatory requirements. This role is on-site 5 days a week and will eventually move to Morrisville, NC at a later date. Key Responsibilities Provide end‑to‑end leadership for Quality Operations and Compliance across manufacturing, Quality Control, AS&T, and logistics, ensuring adherence to cGMP, regulatory requirements, and internal quality standards. Serve as the final QA authority for review, approval, and release of batch documentation and patient or commercial product lots manufactured at the site. Ensure strong on‑the‑floor QA presence, delivering real‑time quality oversight, decision‑making, and guidance to support compliant and efficient operations. Lead investigations of deviations, OOX/OOS events, complaints, and adverse events, ensuring timely root‑cause analysis, effective CAPA implementation, and sustainable corrective actions. Implement and maintain site Quality Systems, including SOP governance, training compliance, documentation control, and inspection readiness for internal, external, and regulatory audits. Drive QA Operational Excellence through performance metrics (KPIs/KQIs), continuous improvement initiatives, and proactive identification of quality and process risks. Provide QA leadership for technology transfers, process validation, and new equipment commissioning, including review and approval of validation strategies and OQ/PQ execution. Lead, develop, and retain a high‑performing QA team through hiring, coaching, performance management, and resource planning, while supporting budget and capacity planning in alignment with site strategy. Essential Requirements BS or MS in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline; advanced degree preferred. Minimum 10+ years of experience in the pharmaceutical, biotechnology, or cell and gene therapy industry within cGMP regulated environments. Demonstrated experience supporting Small Molecule Operations (SMO), including small molecule drug product and/or drug substance environments. Demonstrated hands‑on leadership in Quality Operations and Quality Systems & Compliance, with direct responsibility for product release, quality systems, and audit readiness within SMO. Minimum 6-10 years of direct people leadership, including team development, performance management, and cross‑functional collaboration. Strong working knowledge of FDA, EMA, and global regulatory requirements, including experience supporting regulatory inspections and audits. Proven experience leading deviation investigations, CAPA management, and continuous improvement initiatives in an operational QA setting. Experience supporting manufacturing operations, Quality Control, validation, and technology transfer activities. Excellent communication, decision‑making, and organizational skills, with the ability to operate effectively in a fast‑paced CGT manufacturing environment. Fluency in English (written and verbal). Compensation and Benefit Summary The salary for this position is expected to range between $138,600 and $257,400 per year. The final salary offered is determined based on factors such as relevant skills and experience. Employees are eligible for a comprehensive benefits package that includes health, life, disability benefits, a 401(k) with company contribution and match, and a generous time‑off package including vacation, personal days, holidays and other leaves. Depending on the level of the role, eligibility to be considered for annual equity awards may also apply. EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. #J-18808-Ljbffr U473 (FCRS = US473) Novartis Gene Therapies