TRD QA Head CMC

Role Purpose

The TRD QA Head CMC, ensures quality oversight of the CMC project portfolio and enabling portfolio within the CMC QA Team. He / she ensures appropriate staffing and prioritization in own area of responsibility.

Location:

Basel, Switzerland #onsite

The TRD QA Head CMC, ensures quality oversight of the CMC project portfolio and enabling portfolio within the CMC QA Team. He / she ensures appropriate staffing and prioritization in own area of responsibility. As a leader of Senior QA Associates and local TRD QA Leads, he / she manages resources and budget linked to the TRD QA team and the TRD platform objective.

He / She promotes a culture of quality, high performance and trust. He / she drives infrastructure, operational and strategic alignment with local and global partners, in close alignment with other TRD and TRD QA Sites. He / she is accountable to ensure quality oversight in the relevant CMC and enabling portfolio initiatives. He/she drives GMP standards in a development environment with emerging technologies, supports proactively BD&L activities, incl.

due diligences. He / she provides servant leadership and strong strategic quality guidance demonstrating ability to navigate in a complex environment with multiple local and global stakeholders of TRD and beyond.

• Achieve and promote a culture of quality, high performance, and trust. Ensure that the most talented associates in the industry are hired, developed, and retained. Builds high performing teams to meet quality and business requirements.
• Manages team (individuals); develops capability in direct reports; conducts performance management; accountable for team talent and succession; builds team culture and engagement
• Accountable to deliver team objectives and to drive local TRD / TRD QA objectives within the defined scope linked to the platform.
• Actively drive the TRD QA strategy in scope for NCE Basel in close alignment with respective business partners and the TRD QA platform leadership. Represents TRD QA in local TRD Leadership teams as appropriate
• Works with partners in Quality, TRD and Operations within same site and/or team scope to provide quality oversight on a continuing basis. Provides expertise and guidance in interpreting applicable Novartis standards, policies and / or health agency regulations and guidelines to assure compliance.
• Provides strong quality guidance, scientific and technical expertise within area of expertise. Supports the TRD Platform Head to continuously improve ways-of-working and adopting quality standards to the evolving portfolio needs to make sure project targets are met.
• Ensures representation of TRD QA Managers in TRD teams, as applicable. Representative the team in project specific development gate meetings as appropriate.
• Contributes to the strategy of projects (CMC or enabling) assigned to the team incl. contingency planning and risk assessments as appropriate to ensure timely achievement of project quality deliverables. Ensure that the strategy followed within the assigned projects is in compliance to cGMP guidelines and internal procedures and in line with TRD and TRD QA strategies and goals.
• Triggers the escalation of quality & compliance issues to management in accordance to Novartis global requirements and drive the implementation of remediation actions in a timely and robust manner.
• Ensures that Novartis Quality policies, standards and systems are fully implemented and meet internal and external (local and global health authority's) expectations. Strives for a balance between high scientific and regulatory standards. Fosters and implements a culture of smart risk taking.
• Identifies key issues in complex situations, keeping focused on the big picture and adapting and prioritizing during change. Demonstrates long term vision by taking a broader view, thinking through indirect consequences and longer-term implications. Enable fast decision making based on data.
• Engage with local and global stakeholders relevant to the team activities from NCE and the TPPM community, global quality, regulatory and Authorities. Integrates diverse perspectives from colleagues to achieve best outcome for the enterprise. Demonstrates influence without authority, work and collaborate across boundaries. Builds situational awareness, adapts leadership style to enhance impact of others and performance of the team.

• Scientifically sound understanding of underlying biology/chemistry/technology; broad QA/regulatory understanding across platform/function; focuses on strategic direction while leveraging deep expertise of others
• Thrives in ambiguity and complexity; addresses unprecedented challenges; creates frameworks and clarity where none exist; sets direction when path is unclear; thinks systemically across platform; anticipates long-term implications and ripple effects;
• Manages team (individuals and/or managers); develops capability in direct reports; conducts…