Novartis
AssocDirectorQualitySystems&Compliance
“Assoc Director Quality Systems&Compliance at Novartis. Skills: quality systems, compliance, cGMP, FDA Regulations, health authority audits and inspections, leading teams, continuous improvement. Act as Deputy to the Site Quality Head on all aspects of site quality inclusive of signing and approving Good Manufacturing Practice and other documents on behalf of the Quality Head as needed. Lead and develop a high-performing quality team, allocating resources to meet critical timelines and site objec”
What You'll Achieve.
ensuring inspection readiness; enabling the delivery of safe, life-changing medicines to patients worldwide; elevate performance through data-driven insights and continuous improvement; ensure regulatory compliance and operational effectiveness; drive compliance improvements
Industry & Context.
anticipating risk; identifying risks; ensuring timely mitigation; robust investigations
What They're Looking For.
Must Have
Bachelor of Science in Chemistry, Biology, Pharmacy, or a related scientific, Minimum ten years of experience in quality systems, quality or regulatory compliance, or Operational GxP areas (like Manufacturing or Development, QC/QA Supplier Quality and/or Post Market Quality within the pharmaceutical, diagnostic and/or medical device industries., Demonstrated experience leading and developing high-performing teams, In-depth knowledge of cGMP, applicable FDA Regulations (e. g. , 21 CFR 4, 7, 11, 211, 212, 314, 803, 806, 820), ICH Guidelines, EU Pharmaceutical Regulations and Directives, ISO Standards, etc., Understanding of United States Pharmacopeia (USP), European Pharmacopeia (EP), American Chemical Society (ACS)., Proven experience leading health authority audits and inspections including front room / back room, readiness, strategy and response to findings / observations.
Nice to Have
advanced degree in Quality, Regulatory, Business, Healthcare, Pharmacy, or a scientific field, Prior experience with aseptic manufacturing environments, Experience in advanced therapies (Cell and Gene Therapy, Radioligand Therapy, etc. )
What You'll Do.
Act as Deputy to the Site Quality Head on all aspects of site quality inclusive of signing and approving Good Manufacturing Practice and other documents on behalf of the Quality Head as needed
Lead and develop a high-performing quality team
allocating resources to meet critical timelines and site objectives
Oversee and continuously enhance Quality Management Systems to ensure regulatory compliance and operational effectiveness
and report Site Quality performance metrics
providing insights and transparency to site leadership
Lead Quality Review Board activities
identifying risks and ensuring timely mitigation and escalation when needed
and facilitate escalations
Lead the Corrective and Preventive Action Review Board
ensuring robust investigations and effective corrective actions
Develop and execute strategies for inspection readiness
including audit preparation
and response planning
Coordinate and monitor Site Quality Plans
and gap assessments to drive compliance improvements
Foster a quality culture by promoting accountability
continuous improvement
and compliance excellence across the site
How You'll Work.
Team & Collaboration
partner with site leadership; influence strategic decisions; elevate performance through data-driven insights and continuous improvement; Foster a quality culture by promoting accountability, continuous improvement, and compliance excellence across the site
Process & Methodology
Site Quality Plans, risk assessments, gap assessments
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