Quality Head Large Molecules and Injectables (d/f/m)

Novartis

  • Kundl, Tirol Slovenija
  • Nedoločen čas
  • Polni delovni čas
  • 1 mesec nazaj
About the roleQuality Head Large Molecules and Injectables (d/f/m), Global Quality STO, Kundl, AustriaSandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.The incumbent will be responsible to lead as disciplinary manager the inhouse and external Quality Large Molecules (LM) and Quality Biosimilar network and will provide guidance to all Site Quality Heads of the global platform in critical quality decisions and will ensure Quality unit independency in decision making on batch disposition.This role can alternatively be filled in Germany, Switzerland or SloveniaJoin us as a Founder of our 'new' Sandoz!Your key responsibilities:Your responsibilities include, but are not limited to:
  • Act as Quality Business Partner to Operations Head of Large Molecules and Injectables for large strategic projects and routine work.
  • Manage, support and supervise the Site Quality Heads and their Quality Units in the assigned sites, ensuring implementation and continuous improvement of Quality systems and programs, adequate resource planning, performance management and quality unit independency.
  • Ensure effective quality oversight over external manufacturer of the platform, provide governance, steering and ensure adequate escalations and remediation processes in place.
  • Ensure timely quality reviews during due diligences of new business opportunities, indicating risks and potential showstoppers, as applicable and definition of potential remediation actions.
  • Ensures an active inspection readiness program is in place driving continuous inspection readiness.
  • Design and implement together with Head of Quality Development an early-involvement-by-operations approach for pipeline products at biosimilar development organizations
  • Together with Global Quality Compliance monitor regulatory and industry trends specifically in the space of biosimilars, implications for the platform and determine opportunities for continuous improvement of the Sandoz Quality Management System
  • Drive and foster people development and talent management initiatives across the sites, ensuring proper development for Quality associates in the assigned sites and adequate implementation of Organization and Talent review.
Role RequirementsWhat you'll bring to the role:
Essential Requirements:
  • University Degree in Natural Sciences (Chemistry, Pharmacy, Biotechnology, Biology)
  • English (fluent), German (desirable)
  • Minimum 10 years of professional experience including Quality and Compliance function in pharmaceutical industry, experience in manufacturing of Biosimilars a plus
  • Experienced in leading large teams and stakeholder management
  • Experience with Authorities inspections including US FDA inspections
  • Proven ability to communicate and collaborate effectively across hierarchies and within a global, matrixed organization in complex environment
  • Ambitious, driven to make difference and open minded
  • Sound knowledge of financials and OpEx mindset
Why Sandoz?Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!The future is ours to shape!Imagine what you could do here at Sandoz!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. 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 €108.430,28/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. We are open for part-time and job sharing models and support flexible and remote working where possible.Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: Job search | Sandoz#SandozFunctional AreaQualityDivisionSANDOZBusiness UnitNON-NVS TSA QUALITY STOEmployment TypeRegularCommitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Shift WorkNoEarly TalentNo

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