TRD Quality Team Head

Location: Basel, Switzerland

Role Purpose:
Leads a group of QA associates at one or more local sites, and manages resource allocation, budget and capacities. Accountable for team objectives and deliverables as per objective setting. Supervise, guide and support global TRD in all quality-relevant topics, questions, and issues. Develop strategies in alignment with TRD considering all relevant cross-functional aspects, to ensure the quality of deliverables in area of responsibility. Ensures constant investment in team capabilities and keeping own and team knowledge up to date.

Major accountabilities:

• Acts as a deputy of the responsible person (FvP “Fachtechnisch verantwortliche Person”) for TRD Switzerland according to AMBV (Arzneimittel-Bewilligungsverordnung) Swiss Law, SR 812.212.1, art. 4, art. 5, art. 7
• Lead and manage the TRD QA Ops team, budget and resources according to objectives. Ensure representation of TRD QA Ops globally in TRD teams, as applicable.
• Actively reviews own and teams competencies and capabilities and develops plans to keep it up to date.
• Ensure quality oversight on the assigned development portfolio with strong quality guidance, scientific and technical expertise.
• Ensure that the strategy followed within the assigned portfolio and team is communicated and in line with TRD and TRD QA strategies and goals and in compliance to cGMP guidelines and internal procedures.
• Understand and proactively manage the interactions between TRD QA Ops and other departments inside or outside of TRD, and ensure that QA Ops input to other TRD and TRD QA groups is provided as needed.
• Proactively escalate key issues and any other critical topics in a timely manner to the appropriate management level according to the escalation procedures.
• Ensure TRD QA Ops presence in Due Diligence teams, to provide quality assessment of potential in-licensing products in a timely manner and to support follow-up activities as appropriate.
• Lead or participate in global and/or cross-functional initiatives.
• Coach and mentor functional experts. Recruit talents and establish development plans

Minimum Requirements:

• Industry/ Business Exposure.
• Critical Negotiations.
• Functional Breadth.
• Operations Management and Execution.
• Collaborating across boundaries.
• Project Management.
• People Leadership.
• Stakeholder Management.

Languages :

• English.

Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.