Job Description Summary
Provide the strategic and technical leadership in all quality related matters to ensure that all aspects of the operational business comply with cGMP, legal and regulatory requirements as well as the Novartis Quality Manual.
Job Description
Your key responsibilities:
Your responsibilities include, but are not limited to:
• Provide the strategic and technical leadership for site Drug Substance Schaftenau and ensure the compliance of the applied quality system to cGMPs and corporate guidelines.
• Acting as the overall Quality responsible person for the site, ensuring product quality, regulatory compliance and implementation of corporate quality standards and regulations
ensuring product quality, regulatory compliance and implementation of corporate quality standards and regulations.
• Ensuring that local Quality Organization as well as the Quality Functions outside your team adequately supports the ongoing production and projects.
• Ensure that the Quality Organization will be able to support business operations in an adequate and competitive way also in future.
• Assume financial and HSE responsibility of the Quality Unit.
• Responsibility for personal and people development specifically for Quality Unit and collaborate with other site functions in this respect.
What you’ll bring to the role:
• University or academic degree in chemistry, biology, pharmacy or equivalent
• Proficient in English required (min C1), German desired (min B2)
• Minimum of 10 years’ experience in an operational GxP area, in Manufacturing, Development or QA; with a thorough knowledge in chemistry, pharmacy and/or biotechnology
• Profound experience leading sophisticated quality organizations in a diverse global matrix environment.
• Ability to speak up and to take Quality decisions during challenging situation.
• Strong leadership skills with excellent interpersonal, communication and negotiation abilities. With confirmed experience in change management and integration of teams and/or organizations.
• Proven track record with FDA, EMA and other Health Authorities.
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Imagine what you could do here at Novartis!
In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities 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 € 112,861.28 (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.
We are open for part-time and job-sharing models and support flexible and remote working where possible.
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Our recruitment decisions are based on selecting the best person for the job, regardless of gender, religion, age, colour, race, sexual orientation, nationality or disability.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Agility, Agility, Audit Management, Business Acumen, Business Partnering, Business Strategy, Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Finance Acumen, Health Authorities, Knowledge Of Gmp, Leadership, Manufacturing Production, Organizational Savvy, People Management, Problem Solving Skill, Product Release, Qa (Quality Assurance), Quality Control, Quality Management, Quality Management Systems (QMS), Root Cause Analysis (RCA), Self-Awareness, Six Sigma {+ 4 more}
