Hiring: Head Quality Systems and Compliance (Assoc Dir) Company: Novartis Location: Durham, NC Job Posted Time: 2026-09-10 10:21:07 Target Skills & Keywords : Regulatory Compliance About the job Experience: •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. •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. Required Skills: •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. Qualifications: •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. •Previous involvement with facility start-ups, qualifications, validations, transfers •To learn more about the culture, rewards and benefits we offer our people click here. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!