Deadline: February 10, 2022 International QA Director

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 the international projects with primary focus on dry form formulation manufacturing, development of new tablet forms for SP-420 in different strengths and for a pediatric formulation. The position will be a part of a team bringing this new drug to the market from early clinical trials to a fully commercialized product intended to be approved in US, EU, Japan and rest of the world. The position will take part of the larger project team involving key persons from different areas in Pharmacosmos Denmark and US. The project is headed up by a dedicated project manager from development responsible for the overall delivery and reporting to the upper management.

The position will be a part of a small international QA director team reporting directly to the VP for Quality and Regulatory Affairs.

The Position is located in Holbaek.

 

Job responsibilities


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 with the primary focus om SP-420 related CMOs.
  • Surveillance of the contract manufactures for API (SP-420) and finished product and packaging sites of SP-420; 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
  • Key responsible for the CMOs related to SP-420

the candidate


Professional qualifications & experience


The International Quality Assurance Director should preferably meet the following professional skills:

  • Formal education at MSc level (pharmacy or the like)
  • Experienced (+10 years) Sr. 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 within production of oral pharmaceuticals in tablets or capsules would be an advantage • Experience with GMP/GDP regulations from the pharma industry within dry form formulations
  • 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 Competencies


  • 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

Attractiveness of the job and organization


  • An important and challenging position where the candidate will secure deliverables on time in high quality – responsibility is broad, influence and independence significant
  • Visible and influential position – part of quality management; be able to make a difference. Influence the set-up of the responsibility area.
  • Growth management
  • Strong ownership – investment and development ongoing
  • Favorable opportunities to develop professionally as well as personally
  • Part of the GMP Steering Committee
  • A national and international dynamic environment
  • Flexible work situation

Travelling


20-25 days a year

Contact


Nordic Headhunting
Partner Ole Koch
+45 40200855
ok@nordicheadhunting.dk

About Pharmacosmos


Headquartered in Denmark, Pharmacosmos is a family-owned, international healthcare company with more than 50 years of innovation and leadership in iron- and carbohydrate-based treatments and solutions for human and animal use.

A research-based company, its ongoing R&D programme focuses on improving the lives of patients with iron deficiency with or without anaemia. More than 1 billion people live with iron deficiency anaemia and it is the leading cause of death for an estimated 180,000 people every year. This makes it one of the largest global health challenges of our time.

Pharmacosmos has subsidiaries in US, China, UK, Ireland, Germany, Sweden and Norway and its products are marketed in more than 80 countries around the world. Its manufacturing facilities are approved, among others, by the Danish Medicines Agency and the US FDA.

Thank

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Pharmacosmos

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