Head Quality Systems and Compliance (Assoc Dir)

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 3

Generous time off

Job summary

Novartis is establishing a new Small Molecule manufacturing site in Morrisville, NC, and seeks a QA Compliance and Systems Head to build and lead the quality foundation from the ground up. You will oversee Quality Systems, Compliance, Audit Readiness, Data Integrity, Supplier Quality, and Validation, collaborating across Quality, Manufacturing, Engineering, and Regulatory functions.

You will drive a culture of compliance and continuous improvement, lead inspections, and support site

Qualifications

• Bachelor or Master of Science in Life Sciences, Pharmacy, Chemistry, Biotechnology, or related field; advanced degree preferred.
• 8–10 years of pharmaceutical manufacturing experience in roles such as Production, MKT, Quality, or Engineering.
• Experience in oral solid dose manufacturing preferred.
• Proven leadership in building talent, driving performance, and ensuring training compliance.
• Significant experience leading FDA inspections and regulatory interactions.
• Strong background in Quality Systems (deviations, CAPA, change control, data integrity, validation).
• Desirable: Lean/Operational Excellence qualifications or certifications.

Responsibilities

• Lead the site Quality Management System and ensure GMP compliance.
• Drive inspection readiness and lead audits by Health Authorities and customers.
• Oversee quality systems including deviations, CAPAs, change controls, data integrity, and validation.
• Partner with Manufacturing, QC, Validation, Engineering, and Regulatory teams to support site operations.
• Lead investigations of deviations and compliance issues and ensure timely resolutions.
• Oversee supplier quality, training governance, and risk management programs.

Job description

Location: Morrisville, NC

Join Novartis as our QA Compliance and Systems Head and help shape the quality foundation that enables the delivery of medicines to patients worldwide. This is a unique opportunity to join our new Small Molecule manufacturing site in Morrisville, playing a critical leadership role in building and advancing the site's quality culture, systems, and compliance programs from the ground up. You will oversee Quality Systems, Compliance, Audit and Inspection Readiness, Data Integrity, Supplier Quality, and Validation programs while partnering across Quality, Manufacturing, Engineering, and Regulatory functions. As a key member of the site Quality leadership team, you will drive a culture of compliance, continuous improvement, and operational excellence while ensuring inspection readiness and supporting the site's long-term growth and transformation journey.

Key Responsibilities

• Lead the site Quality Management System and ensure compliance with Novartis Quality Manual, current Good Manufacturing Practice requirements, and regulatory standards.
• Drive continuous inspection readiness and lead preparation for corporate audits, customer audits, external audits, and Health Authority inspections.
• Provide oversight of quality systems including deviations, corrective and preventive actions, exceptions, change controls, data integrity, eCompliance, key performance indicators, and key quality indicators.
• Partner with Manufacturing, Quality Control, Validation, Technical Operations, Engineering, and Regulatory teams to support site operations, technology transfers, qualifications, and validation activities.
• Lead investigations of deviations, out-of-expectation events, complaints, and compliance issues, ensuring timely and effective resolution.
• Oversee supplier quality, regulatory compliance, training governance, and risk management programs that support sustainable inspection readiness.
• Lead, coach, and develop the QA Compliance and Systems team through effective resource planning, performance management, talent development, training governance, and sustained training compliance.
• Promote a strong quality culture built on accountability, collaboration, continuous improvement, employee development, and proactive risk management.
• Advance digital enablement and continuous improvement initiatives that strengthen quality performance, simplify processes, and support site transformation.

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 experience in pharmaceutical manufacturing, which may include expert roles in Production, Manufacturing Science and Technology, Quality, or Engineering.
• Prior experience in oral solid dose manufacturing preferred.
• Demonstrated leadership experience managing teams, developing talent, driving performance, fostering training compliance, and building a culture of accountability and collaboration.
• Significant experience leading FDA inspections, regulatory interactions, audit readiness activities, and inspection remediation efforts.
• Strong experience leading Quality Systems programs, including deviations, corrective and preventive actions, change control, data integrity, validation, and compliance oversight.
• Proven ability to lead risk management, continuous improvement, and compliance initiatives in highly regulated manufacturing environments.

Desirable Requirements

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

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.