Head Site QA Operations/Assoc Dir

Key Responsibilities

• Lead and inspire the Site QA Operations team, including QA Shop Floor, QA Batch Release, and QA Engineering, fostering a culture of excellence and accountability.
• Act as Responsible Person for timely and compliant final product disposition decisions.
• Drive strategic resource allocation and capacity planning to meet GxP and Novartis standards.
• Champion continuous improvement and empower teams to deliver robust quality systems across operations.
• Represent the site in FDA and regulatory interactions, ensuring successful submissions and compliance.
• Oversee audits and inspections, setting readiness strategies and guide teams through responses.
• Build and mentor future leaders, promoting collaboration and a strong quality culture across the organization.

Essential Requirements

• Bachelor’s degree in Chemistry, Biology, Pharmacy, Biochemistry, Engineering, or related experience; advanced degree preferred.
• 10 years in Quality Assurance, Quality Control, Quality Systems, Compliance, Operational GxP area(s) (Manufacturing/Development) within pharmaceutical or medical device industries.
• Proven track record of leading a Quality Assurance organization and developing high-performing teams.
• Prior experience with aseptic pharmaceutical manufacturing.
• Direct experience with investigations and root cause analysis in pharmaceutical or medical device products.
• Deep knowledge of current Good Manufacturing Practices and aseptic pharmaceutical manufacturing standards. Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS).
• Demonstrated success in managing regulatory inspections and Health Authority audits, including strategy and response.
• Ability to influence cross-functional teams and drive a culture of quality and continuous improvement.

Desirable Requirements

• Experience in advanced therapies such as Cell and Gene Therapy and Radioligand Therapy.
• Experience with process improvement: Lean, Six Sigma, and Five S workplace organization (5S).

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 like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

To learn more about the culture, rewards and benefits we offer our people click here.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards