Head of External Manufacturing
Warszawa

Boost your career with us

Polpharma Biologics is a state-of-the-art biological R&D and manufacturing facility, one of the most modern in Europe. We have a fantastic, international team of experienced experts and dynamic young scientists with common goals and values. Biotechnology is our passion.

Together we develop medicines, offering a new hope to patients suffering from serious diseases. We create a passionate and friendly workplace environment. Join us!

Your role

You will be responsible for establishing and managing all relationships with CMOs to assure on-time supply of products and services execution to cover Polpharma Biologics contractual obligations towards Commercialization Partners (regarding API, Drug Products and Finished Products deliveries). Co-lead negotiations regarding supply and technical contracts as well as managing them once signed. Responsible for ensuring appropriate oversight, assessment and mitigation of risk to supply, and for ensuring that all aspects of the proper relationships with vendors and contractors, and the management thereof, follow cGMP and regulatory requirements, Polpharma Biologics Group procedures, instructions, industry practices and concluded contracts.

Your responsibilities

  • Source, establish, manage, support and supervise relationships with PB CMOs, basing on PB contracting and product strategy.
  • Responsible for appropriate product and services sourcing according to strategic business rules and needs in order to meet demand plan.
  • Support and create External Contracting general strategy and data base.
  • Support External Vendors’ Management and Assessment.
  • Support the Supply and Quality Assurance Agreements negotiations (co-lead them), make sure that they include responsibilities and requirements of all parties involved in the supply of the product. Make sure that contractual stipulations can be met, manage relationships also in case of problems or possible obstacles. Support repair plans and escalation procedures.
  • Support activities of Quality Teams in respect to External Manufacturers performance, make sure it is carried out according to the standards defined, regularly reported and gather feedback their performance.
  • Make sure that production and quality strategy for the External Manufacturing of PB are incorporated into negotiations and contracts with External Manufacturers.
  • Settle proper communication and co-operation flows between PB functions: Business Alliances, Supply Chain, Launch Managers and Quality Assurance Head of External Manufacturing and Partnering, assuring successful planning of contracts coverage.
  • Represent PB at governance bodies as per agreements with Commercialization Partners.
  • Provide representation on External Manufacturing Boards and for projects (tech transfers, launches, due-diligence, others).
  • Coordinate Logistics flows (all sites) inbound, outbound and internal.
  • Monitor and promote positive Third-Party and Supplier Relationships. Facilitates open and forthright communication, constructive feedback, cooperation, and rapid issue resolution. Assure and control meeting by Suppliers and Contractors Rules for Polpharma Biologics’ Partners.
  • Assess all resources needs and identify external resources that must be supplied to cover successful contracts execution.
  • Cooperate and communicate (together with Quality Team representative) regarding External Suppliers readiness for HA inspections (PAI, directed, other).

If you have

  • Master’s or doctoral degree in a relevant field (pharmacy, biotechnology, biochemistry, chemistry).
  • 10 or more years’ experience in the pharmaceutical industry, with direct experience with Pharmaceutical/Biopharmaceutical/API products. Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA or production roles and 3 years of project management experience.
  • Thorough knowledge of cGMP requirements.
  • Understanding of regulatory requirements for commercialization of pharmaceutical of biological products.
  • Proven track record of External Manufacturing Management.
  • Strong understanding of risk assessment and business continuity management.
  • Technical understanding of manufacturing/quality processes.
  • Strong organizational and project management skills to be able to lead cross functional teams.
  • Strong leadership, influencing and communication skills.
  • Strong work ethic, cultural awareness and sensitivity.
  • Ability to work adapt to the company and local culture in a transformational complex environment.
  • Can do attitude and willingness to transform organization with strong focus on people and projects execution.
  • English – business proficiency, speaking or willingness to learn Polish is an advantage.

We offer

  • Private healthcare;
  • Life insurance;
  • Pension plan above national standards;
  • Relocation package;
  • Additional free day;
  • and more…
Join our Team!

Why you should work with us

Contact us
[email protected]