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