Head of QA Pharmaceuticals Belgium and Ireland
4 jours restants
- Temps de travail
- Temps plein
That's XPE. For one of our clients we are looking for: Head of QA Pharmaceuticals Belgium and Ireland Organisation description: Job description:
ROLE AND RESPONSIBILITIES:
- Overall responsibility for the Quality Assurance function in the group
- Implement cost effective QA operations to ensure a lean and agile structure based on a trade off between risks and costs.
- Identify a general QA strategy with the business unit managers, taking in account the overall objectives of the company
- Assist in building and maintenance of (virtual) QA systems with a clear mission to simplify as much as possible
- Manage a pool of talented people on a daily basis; to improve the overall working of the QA department
- Brief HQ and local management about overall performance
- Assign tasks to each QA team leader, in line with direction from the company board, and monitor performance levels.
- Establishment and maintenance of regular Group QA meetings to manage progress and involve Quality leads from each QA group to promote exchange of knowledge/experience.
- Management of QA interactions with Third parties (including CMOs, Active Substance Manufacturers (ASMs) and Market Authorisation Holders (MAHs), both in the supply and the R & D environments.
- Maintenance of all regulatory authorisations for all sites in the group (Manufacturing and Importation Authorisations (MIAs), Wholesale Dealing Authorisations (WDAs), Brokerage Licenses and API distribution/importation registrations).
- Maintain close working relationship with the R&D group to ensure QA requirements are covered in all dealings with API suppliers and CMOs and to communicate these requirements to the various QA leads
- Report on a regular basis to the CEO
- Manage the cross-functional working group to assess all instances of product critical defects to ensure that a disciplined procedure is maintained involving all relevant stakeholders to decide whether a particular batch of product requires any specific action.
- Ensure each Quality group keeps their knowledge up-to-date with changing GMP requirements by attendance at local forums held by the national competent authority and by the use of suitable training programmes with internal and external resources where necessary.
- Qualified Person status is preferred
- Preferably pharmacy/chemistry graduate
- Minimum 20 years' experience in the pharmaceutical industry, (MUST include significant experience in GMP, in roles of a related discipline e.g. Quality Assurance, Operations).
- Minimum 5 years' experience at senior management level
- Experience in managing a multi-site organisation and with the FDA would be valued.
- Languages: very good English (written and oral). Other languages are an asset.
- Proven leadership skills
- Proven ability to manage complex quality issues and deliver solutions without endangering business continuity.
- Proven ability to understand, analyze and communicate the impact of cGMP quality issues affecting the drug development process and supply.
- Proven ability to work in multidisciplinary teams and ability to balance the requirements of cGMP with the business reality.
- Flair for IT and good IT skills especially with Excel and Power Point.
- Ability to contribute proactively to a continuous learning and process improvement environment;
- Good capacity to react to and cope with unexpected situations and changing priorities;
- Detail-orientated with the ability to check technical documents for accuracy and inconsistencies,
- A wide knowledge of all aspects of the pharmaceutical industry is considered essential. Previous experience in the generics industry is highly valued.
- Maintain a pragmatic approach to problem solving, within the discipline of a business environment.
freelance or fix contract
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713