QA Operations Head (Associate Director)

Biopharma Careers; United States; On-site; USD 139,000 - 257,000; Full time

Benefits offered by this job

Health, life and disability benefits

401(k) with company contribution and 2

Generous time off package includingvac

Job summary

Novartis seeks a QA Operations Head to lead Quality Operations for a new small molecule site in Morrisville, partnering with Manufacturing, Quality Control, and technical teams to drive operational excellence, product quality, and regulatory compliance.

As a site leader, you will develop high-performing teams, champion continuous improvement, and shape the future of quality within a dynamic manufacturing environment.

Qualifications

• 8–10 years of pharmaceutical experience including direct experience in oral solid dosage manufacturing.
• Quality Operations leadership with responsibility for product release, compliance, inspection readiness, people leadership, talent development, performance management, and cross-functional collaboration.
• Experience with Health Authority inspections (preferably FDA) and regulatory procedures.
• Proven experience leading deviation investigations, CAPA, validation activities, and continuous improvement initiatives.

Responsibilities

• Lead Quality Operations oversight to ensure compliance across manufacturing activities and QA Operational Excellence.
• Provide quality leadership for product release, batch record review, and disposition activities.
• Drive investigation of deviations, out-of-expectation results, and complaints, ensuring effective corrective actions.
• Lead continuous improvement initiatives to strengthen quality performance, compliance, and operational excellence.
• Support validation, technology transfer, commissioning, and implementation of new manufacturing processes and equipment.
• Ensure ongoing inspection readiness and successfully support internal, customer, and regulatory audits and inspections.
• Develop, coach, and lead high-performing teams while fostering a culture of accountability and learning.
• Manage resources, capacity planning, and quality metrics to achieve business and compliance objectives.
• Explore the potential of data and technology to support the manufacturing site's transformation journey in line with Novartis Technical Operations strategy.

Skills

Quality Operations leadership

People leadership

Cross-functional collaboration

Performance management

Regulatory compliance

Education

Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related discipline

Advanced degree preferred

Job description

Join Novartis as our QA Operations Head and play a pivotal role in ensuring patients receive high-quality medicines that meet the highest standards of safety, compliance, and reliability. This is an opportunity to lead a critical Quality Operations organization at our new small molecule manufacturing site in Morrisville, partnering closely with Manufacturing, Quality Control, and technical teams to drive operational excellence, product quality, and regulatory compliance. As a visible site leader, you will empower and develop high-performing teams, champion continuous improvement, and help shape the future of quality within a dynamic and growing manufacturing environment.

Key Responsibilities

• Lead Quality Operations oversight to ensure compliance across manufacturing activities and QA Operational Excellence.
• Provide quality leadership for product release, batch record review, and disposition activities.
• Drive investigation of deviations, out-of-expectation results, and complaints, ensuring effective corrective actions.
• Lead continuous improvement initiatives to strengthen quality performance, compliance, and operational excellence.
• Support validation, technology transfer, commissioning, and implementation of new manufacturing processes and equipment.
• Ensure ongoing inspection readiness and successfully support internal, customer, and regulatory audits and inspections.
• Develop, coach, and lead high-performing teams while fostering a culture of accountability and learning.
• Manage resources, capacity planning, and quality metrics to achieve business and compliance objectives.
• Explore the potential of data and technology to support the manufacturing site's transformation journey in line with Novartis Technical Operations strategy.

Essential Requirements

• Bachelor of Science or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related scientific discipline; advanced degree preferred.
• Minimum 8-10 years of relevant pharmaceutical experience including direct experience in oral solid dosage manufacturing which can include expert roles in Production, Manufacturing Science and Technology and/or Engineering, in addition to Quality.
• Demonstrated Quality Operations leadership experience with responsibility for product release, compliance, inspection readiness, people leadership, talent development, performance management, and cross-functional collaboration.
• Experience with Heath Authority inspections (preferably FDA) and regulatory procedures.
• Proven experience leading deviation investigations, corrective and preventive actions, validation activities, and continuous improvement initiatives.

Desirable Requirements

• Previous involvement with facility start-ups, qualifications, validations, transfersQualifications or certification in Lean Management, Operational Excellence, or continuous improvement methodologies.

Salary

• 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.

Benefits

• 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.