QA Operations Head (Associate Director)

Job Description Summary

Job Description

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 sites 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 transfers
• Qualifications or certification in Lean Management Operational Excellence or continuous improvement methodologies.

The salary for this position is expected to range between $138600 and $257400 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 -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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

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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.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If because of a medical condition or disability you need a reasonable accommodation for any part of the application process or to perform the essential functions of a position please send an e-mail to or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

Skills Desired