TRD QA Team Lead Biologics CMC (m/f/d)

Salary Range:

€85,300.00 - €158,300.00

 

Job Description Summary

The TRD QA Team leader CMC Biologics, ensures quality oversight of the CMC project portfolio within CMC QA Team and ensures appropriate staffing and prioritization in own area of responsibility. Accountable for QA release activities of CMC QA Biologics. As a leader of TRD QA Associates he / she manages teams, resources and budget linked to the TRD QA team objectives. He/She promotes a culture of quality, high performance and trust. He/she drives infrastructure, operational and strategic alignment with partners related to the business scope and project portfolio. He/she is accountable to ensure quality oversight in the CMC QA Team and all related release activities. This includes deviation and escalation management. He/she ensures GMP compliance in all day-to-day interactions. He she provides servant leadership and strong quality guidance working with multiple stakeholders within TRD Biologics Austria.

Location: Schaftenau, Austria

#LI-Hybrid

 

Job Description

Major Accountabilities:

• Achieves and promotes 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 [enter team and scope] in close alignment with respective business partners and the TRD QA platform leadership. 
  Represent TRD QA in local TRD / Operations leadership teams as appropriate
• Work with partners in Quality, TRD and Operations within same site and/or team scope to provide quality oversight on a continuing basis.
  Provide expertise and guidance in interpreting applicable Novartis standards, policies and / or health agency regulations and guidelines to assure compliance.
• Provide strong quality guidance, scientific and technical expertise within area of expertise.
•  Support the TRD QA local head/platform head to continuously improve ways-of-working and adopting quality standards to the evolving portfolio needs to make sure project targets are met.
• Ensure representation of TRD QA Managers globally in TRD teams, as applicable.
• Represent the team in project specific development gate meetings as appropriate.
• Contribute to the strategy of projects (CMC or infrastructure) 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.
• Trigger 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.
• Ensure that Novartis Quality policies, standards and systems are fully implemented and meet internal and external (local and global health authority's) expectations.
• Strive for a balance between high scientific and regulatory standards.
• Foster and implements a culture of smart risk taking.
• Identify key issues in complex situations, keeping focused on the big picture and adapting and prioritizing during change. Demonstrate 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 [enter TRD dep], global quality, regulatory and Authorities.
• Integrate diverse perspectives from colleagues to achieve best outcome for the enterprise.
• Demonstrate influence without authority, work and collaborate across boundaries.
• Build situational awareness, adapt leadership style to enhance impact of others and performance of the team.

Key Performance Indicators:

• Scientifically sound understanding of underlying biology/chemistry/technology; strong QA/regulatory expertise with broader functional perspective; integrates knowledge across multiple quality domains
• Navigates ambiguity effectively; solves problems with multiple variables; comfortable making decisions with incomplete information; adapts as situations evolve;
• Manages team (individuals ); develops capability in direct reports; conducts performance management; accountable for team talent and succession; builds team culture and engagement
• Makes decisions affecting team/functional area outcomes; balances operational priorities and resolves competing demands; accountable for area deliverables; high autonomy within management scope
• Manages Headcount/Budgets and ensures resource needs are identified, discussed, and allocated across projects/initiatives
• Accountable for compliance outcomes across team/department or program; owns risk management and mitigation strategies; accountable when compliance failures occur in area of responsibility; ensures regulatory readiness; makes risk-based decisions with appropriate escalation
• Balances operational execution with strategic input; identifies opportunities for improvement; contributes to planning and strategy discussions; translates strategy into operational actions within area.
• Communication & Collaboration: Communicates clearly across functions and stakeholders; influences effectively at senior levels within function; builds strong cross-functional relationships We take smart risks and learn: Empowers team to take smart risks; models learning from setbacks; creates environment where failures are learning opportunities Unbossed & Accountable: Holds self and team accountable for results; addresses performance issues; operates with broader organizational perspective beyond own team interests; drives initiatives forward with strong sense of ownership and urgency
• Role Model of Novartis culture, values, & behaviours

You’ll receive:

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities as well as worldwide career possibilities within the Novartis group. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is € 78,383.90 a year (on a full-time basis). The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive working environment and diverse teams, representative of the patients and communities we serve.

Adjustments for Applicants with Disabilities:

If because of a medical condition, physical disability or a neurodiverse condition you require an adjustment during the recruitment process, please reach out to [email protected] and let us know the nature of your request as well as your contact information. The support which we can provide will include advice on suitable positions as well as guidance at all stages of the application process. Austrian law provides candidates the opportunity to involve the local disability representative, Behindertenvertrauensperson (BVP), in the application process. If you would like to request this, please let us know in advance as a note on your CV.

 

Skills Desired

Collaboration, Data Integrity, Leadership, Risk Management, Stakeholder Management