International QA Director

International QA Director

Pharmacosmos

Holbaek, Denmark

The Position

The International QA Director has the responsibility to ensure that Pharmacosmos’ external and outsourced activities comply with Pharmacosmos requirements, applicable rules for good manufacturing and distribution practice (GMP and GDP) and other applicable rules for Pharmacosmos pharmaceuticals and API products. This position has no direct staff reports and is a new position to strengthen international projects. The position reports directly to VP Quality and Regulatory Affairs.

The International Quality Director is responsible for:

  • Quality oversight at all external relations (outside site Holbaek);
  • Making sure that the quality is current and maintained with all CMOs, vendors, affiliates and partners;
  • Surveillance of the aseptic contract manufactures, and packaging sites; ensuring compliance with the agreed terms specified in the quality agreement (technical agreement), cGMP and GDP;
  • Making certain that all existing legislation is implemented in all relevant external collaborations;
  • Product transfers from one manufacturing site to another (transfer plan, process validation, stability studies, etc.);
  • Transfer of analytical methods;
  • Participate in/secure technology transfers to and between external stakeholders;
  • Keeping quality agreements up to date;
  • Qualify new CMOs and vendors;
  • Keeping up to date with the Pharmacosmos quality management system and ensuring new requirements and/or quality event information are passed on to contract acceptors and partners in a timely manner;
  • Supervise selected development projects outside site Holbaek;
  • Audits of CMOs, distributors and vendors (as part of the audit team) in line with the internal/external audit plan;
  • Supporting the other members of the quality management team with tasks in connection with audits, inspections, questions from regulatory authorities, training and continuous improvement of the Pharmacosmos quality management system.

Critical success factors; the International Quality Director will secure:

  • Efficient handling of quality matters;
  • Up-to-date and efficient systems and administrative processes;
  • A strong relationship and continued dialogue with all relevant internal and external stakeholders.

The position is located in Holbaek.

The Candidate

The International QA Director should preferably meet the following professional skills:

  • Formal education at MSc level (pharmacy or the like);
  • Experienced (+10 years) QA manager or Sr. Specialist with a strong business sense from international environment;
  • Have a strong understanding of the quality processes – a minimum of 10 years of QA experience expected this combined with Production experience would be an advantage;
  • Experience with GMP/GDP regulations from the pharma industry within aseptic production;
  • Experience with CMO’s in general, external audits and Quality agreements (technical agreements);
  • Must be customer (internal/external) focused and able to deal with ambiguity;
  • Ability to establish a good collaboration with internal and external stakeholders;
  • Language skills: English at negotiation level both verbal and in writing.

Personal profile:

  • Strong interpersonal skills – robust with natural authority, easy going;
  • Sets clear direction - inspires for continuous improvement;
  • Likeable/positive personality;
  • Decision maker who challenges status quo;
  • Understands business and customer needs; a ‘doer’ – getting things done, also when the pressure is high;
  • Communicates effectively at all levels and presents complex and/or new ideas with clarity and simplicity;
  • Analytical and systematic.

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© EuroJobsites 2019

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

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