Relationship Director managing a portfolio of high - value clients, driving strategic new business development for banking solutions. Collaborating with Corporate Directors and senior stakeholders to originate complex opportunities.
About the role
- Lead quality operations as Senior Director at Teva Biotech. Oversee compliance, manage teams, and ensure adherence to regulations in biopharmaceutical production.
Responsibilities
- In your new role as Senior Director – Head of Site Quality, Biotech, your responsibilities will include: Leadership and personnel management: lead, motivate and develop employees (4–5 direct reports) in accordance with the company’s leadership principles and mission.
- Develop concepts for the expansion of facility and personnel resources within your area of responsibility for decision by executive management (change leadership).
- Lead Quality Control: ensure compliance with all quality-relevant national and international guidelines and legal requirements for biopharmaceutical active substances manufactured by genetic engineering at Teva Biotech GmbH, as well as for biopharmaceutical medicinal products insofar as activities subject to medicines law are performed.
- Ensure compliance with national and international guidelines and legal requirements related to the role of the Qualified Person under §14 of the German Medicinal Products Act (AMG) for biopharmaceutical active substances produced by genetic engineering.
- Ensure laboratory activities, including analytical method transfers, testing and release decisions for raw materials, packaging materials, in-process materials, biotechnological active substances and finished biopharmaceutical products for the site.
- External representation of Teva Biotech GmbH to regulatory authorities and during audits: manage communication with authorities, coordinate and organize regulatory inspections, participate in internal and external audits, and ensure timely and appropriate remediation of findings within your area of responsibility.
- Coordinate and participate in responses to deficiency reports.
- Integration of quality processes: ensure that relevant quality aspects are embedded in the site management team’s decision-making and in the planning and advancement of the site’s operational activities.
- Provide timely guidance and advice to the site management team on implementation of policies, quality rules and quality-related issues.
- Strategic planning and cost responsibility: plan the short- and medium-term development of the area under your responsibility in line with the company’s strategic direction; prepare the cost center budget and ensure investments are implemented on time and within budget.
Requirements
- A degree in the natural sciences, preferably Biology, Biochemistry, Biotechnology or Pharmacy (with a pharmacist’s license/approbation where applicable); a PhD is desirable.
- Minimum of 10 years’ professional experience in pharmaceutical and biopharmaceutical manufacturing, quality control and quality assurance, including interaction with national and international regulatory authorities.
- Several years of experience with personnel leadership and budget responsibility.
- Excellent knowledge of GMP and in-depth understanding of medicinal product regulations (national and international laws and guidelines), with practical experience working with regulatory authorities.
- Experience in business administration and Lean methodologies, as well as project and change management.
- Fluent in German and English, both written and spoken, including pharmaceutical-specific English terminology.
Benefits
- At Teva we take care of your health (e.g., through occupational health management, a company physician, physiotherapy, sports offers and a company canteen).
- You have time for your family (through an on-site company kindergarten and holiday programs for schoolchildren, as well as 30 days of vacation).
- You can develop your potential (through a comprehensive virtual training program).
- Your performance is appreciated (e.g., recognition and Senior Leaders programs, as well as various company events).
- We plan your future together with you (for example, through a company pension scheme).
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