Head of Permitting & EHS (m/f/d)

Stellenbezeichnung: Head of Permitting & EHS (m/f/d)

Firma: WuXi Biologics Germany GmbH

Arbeitsort / Location: Wuppertal, Nordrhein-Westfalen

Job Beschreibung: WuXi Biologics is a world-class biologics services provider (from discovery, through to commercialisation) with global clients in the biopharmaceutical and healthcare industries. Our mission is to accelerate and transform discovery, development and manufacturing in the fast growing field of biologics to benefit patients worldwide. The company has sites/offices in China, US, EU, Asia and Israel. The company currently employs over 5,000 employees worldwide, and are providing services to over 200+ clients globally, including 13 of the top 20 biopharmaceutical companies.

This role will operate in a cross-site set up covering our drug substance and drug product site in Germany.

Ensuring that our companies EHS system is maintained and further developed at the highest level and company always complies with the regulation and international standards. Further this role will be the single point of contact for all permits and authority communication with the local competent authorities. Providing functional and disciplinary leadership to the health and safety engineers and building collectively the EHS ecosystem. Collaborate closely and effectively with all departments regarding safety, health and environmental needs and initiatives. Support other departments in all permit related matters like import permitting, sample distribution etc.. Manage the interface to the Chempark departments within Bayer and Currenta regarding all permit related matters.

Essential Duties and Responsibilities

  • Develop an appropriate submission and regulatory strategy for the operating licenses of WuXi Biologics in Germany for GMP permit and Manufacturing Authorizations.
  • Leading all communication with local authorities for the different matter topics e.g. BimSchG, GMP, GenTG, Construction Permits, Waste and the various other permits needed to operate
  • Create the necessary dossiers in alignment with governing law and in close collaboration with e.g. Quality Assurance, Manufacturing Sciences and Technology, Engineering and clients.
  • Take responsibility for the planning and execution of inspections by local authorities in close collaboration and alignment with other departments and under the prerequisites of the client projects timelines.
  • Ensure the company is maintaining an always up to date permit register and is closely communicating any relevant change with the competent authorities according to local requirements
  • Work closely with the global Regulatory Affairs department on CTDs and other Technical Registration Documents and provide input with the local perspective an drequirements
  • Leading the companies local environmental and sustainability efforts by aligning closely with the global standards and initiatives and plan and execute any initiatives on the German sites
  • Lead and develop a team of currently 2 EHS engineers embedded into a global site network of the company
  • Maintain and further develop the EHS ecosystem incl. but not limited to training, risk assesements, documentation an dreporting.

Strategic and Leadership Skills

  • Excellent leadership skills and proven track record in building trustful relationships.
  • Strong conceptual and strategic thinking with entrepreneurial mindset, hands on mentality linking vision to workable solutions.
  • Demonstrated interpersonal skills dealing with various cultural and professional background.
  • Communicate effectively across the organization and provide guidance and inspiration to the overall organization.
  • Ability to build trustful relationships and successfully negotiate with competent authorities.

Technical Skills

  • Broad understanding of German regulation of the various disciplines but especially in GMP regulated environments
  • Proven track record in the successful licensing of Pharma/Biotech Facilities in the german legislation
  • Strong understanding of EHS ecosystems and state of the art solutions for fast growing companies
  • Strong knowledge of regulatory guidelines: GER, EU, US, ICH, etc.

Qualification & Experience

  • Master/Diploma in the field of Regulatory Affairs, Biotechnology, bio-engineering, biochemistry or similar, PhD required, with a min. 10 years of relevant regulatory affairs and industry experience in the phamra/biopharmaceutical arena.
  • Extensive experience in biologics drug substance and drug product licensure pathways both for clinical and commercial products and the licensing process for new facilities
  • Strong understanding of Pharma and Biotech Processes with its individual Unit Operations in DS and DP manufacturing
  • Ideally hands on experience in Process Validation and Cleaning Validation activities
  • Solid understanding of related regulations and ability to abstract general concepts and approaches
  • Excellent German and English language skills, both written and spoken.

Durch unsere PROUD-Kultur (Passion-Reward-Ownership-United and Determined) fördern wir lebenslanges Lernen, Integration, Flexbilitat, Ehrlichkeit und Zuverlässigkeit. Außerdem haben wir uns dazu verpflichtet unserer Gemeinschaft und Gesellschaft etwas zurückzugeben.

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