About this role
Band Level 5 Job Description Summary The BR Quality Operations role is primarily responsible for managing and executing quality related operational activities, continuous improvement initiatives and for leading/supporting execution of Quality Due Diligence (DD) activities, related integration, and Third-Party oversight. The role is responsible for assuring compliance to regulatory and internal standards/guidance of operational and BD&L / M&A activities within respective/assigned areas.
The role leads/supports the focused (where applicable) and confirmatory due diligence to identify potential quality gaps, risks, and issues in a proactive manner, proposes mitigation, and ensures transparency throughout the DD through integration process. Escalates where applicable and briefs BR Quality and DD management. Job Description Major Activities
• Executes Quality Operational & continuous improvement activities. • Responsible for all relevant Due Diligence, Integration, and Third-Party management activities as outlined in the applicable procedures. • Conduct focused (where applicable) and confirmatory due diligence to detect quality assurance risks, trends and to identify potential quality and performance issues with in-licensed medicinal products and/or inclusive product portfolio in cases of acquisition. • Collaborate with BD&L / M&A DD teams to ensure timely communication of risks to the business and follow-up on required actions for respective QA areas of expertise/focus. • Owner of inputs to the overall DD report for assigned QA focus area and input to finalize QA due diligence report in collaboration with BD&L QA Partners per defined timelines. • On assignment of applicable integration activities, partner with respective integration teams to execute/ oversee QA remediation activities and action plans for assigned QA focus area. • Provides support for internal and external audits and inspections. • Lead/Participate relevant Third Party (vendor oversight) quality activities including CRO selection, governance, and performance monitoring) as outlined in applicable procedures. • Collaborates with internal business partners, R&D Procurement and other Novartis functions to participate in vendor selection and strategic planning, review quality requirements, perform risk evaluation and follow-up on required actions. • Drive quality initiatives and continuous improvement for internal & out-sourced activities to assure compliance with regulations & Quality procedures and implement operational quality efficiencies. • Fulfill Functional Representative (FR) responsibilities for designated projects and activities. Ideal Background
• Ph.D. or Masters in Life Sciences, Pharmacy or Medi-cines.
• Demonstrated quality/scientific operations experience with a minimum of 8 years (AD) 4 years (Manager) working in a pharmaceutical industry with knowledge of R&D programs (research, preclinical safety, bioanalytics and clinical)
• Broad understanding and interpretation of regulatory requirements understanding of Industry Quality Standards and International Regulations (OECD, FDA, GLP, GCP)
• Expertise in managing third parties and in conducting internal / external scientific & quality assessments
• Familiarity with chemical / bio analytical methods, Cell & Gene /Radio Ligand / xRNA platforms, Cell and Molecular Biology, Animal Welfare is a plus.
• Strong leadership experience including excellent communication, collaboration/consensus building, considerable organizational awareness, influencing and negotiation skills.
• Demonstrated ability to lead and partake interdisciplinary-nary projects with scientific, finance, and/or commercial business functions and successfully work in a global cross-functional matrix.
• A clear sense of personal accountability, an ability to empower people, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.
• Strong risk management skills, ability to balance with strategic benefits, and to translate appropriately.
• Strong customer focus and quality driven
Skills Desired