Summary
About the Role
Major accountabilities:
- Ensure that all aspects of the handling, manufacturing, testing, release of products at the site are compliant with GMP, GDP, Corporate Standards and any applicable local/international Regulatory Standards.
- Staff, train and develop the quality department
- Provide leadership, direction and support to the people within the Quality department and ensure that they are qualified, achieve a high level of competence, are motivated and carry out their duties in a safe manner.
- Coordinate with other members of the management's operating team in the day-to-day conduct of the site's business.
- Develop and implement processes to improve quality, demonstrate ongoing control and cost efficiency.
- Maintain, along with your team the plant in a validated state.
- Participate in, respond to all Health Authority, internal and external audits, and be the site responsible for this matter. Be the Quality spokesperson during external audits.
- Prepare, present and manage the budget for operational expenses, headcount and capital investments
- Ensure adequate management of product critical quality issues (deviations, out of specifications). Ensure investigations are accurately executed and adequate CAPAs are defined, and accurately follow up of CAPAs efficiency.
- Define, implement, supervise, consolidate, and analyze Site Quality KPIs. Drive for Site management team accountability.
Minimum Requirements:
- Bachelor's degree in Pharmacy, Chemistry, Chemical Engineering or related field. (Advanced degree is preferred.)
- Minimum of 10 years' experience in an operational GxP area, in Manufacturing/Development or Quality.
- Profound experience leading sophisticated quality organizations in a diverse global matrix environment.
- Ability to speak up and to take Quality decisions during challenging situations.
- Strong leadership skills with excellent interpersonal, communication and negotiation abilities. With confirmed experience in change management and integration of teams and/or organizations.
- Expertise in organization dynamics and culture, ability to gain trust and confidence at all levels in the organization, leadership and project management experience.
- Ability to work independently and effectively in international, complex and multifaceted environments.
- Advanced level of writing/speaking skills in English.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
