| Job ref: | J010347/AMC |
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| Position type | Permanent |
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| Location | Basel |
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| Industry | Information Technology |
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Vacancy details
A excellent opportunity has become available for a Head Global Pharmacopoeial Affairs
with a leading Pharmaceutical company in Basel, Switzerland. The Head Global Pharmacopoeial
Affairs opportunity is a pivotal role in developing external relationships as well
as developing the internal cross-divisional network.
Key Responsibilities
- Identify pharmacopoeial liaisons and maintain overview on related company SPOCs.
- Develop and maintain cross-divisional company Expert Network.
- Ensure know-how transfer within and succession planning for the cross-divisional
company Expert Network
- Manage and collaborate with Pharmacopoeias in defending the interests of company.
- Lead the public consultation process for new pharmacopoeial regulation and ensure
the definition of a position.
- Proposes ways to proceed from company in general chapters and promote harmonisation
with other Pharmacopoeias.
- Effective communicate “internal positions” on draft quality related legislative
texts (compendial monographs, quality and/or GMP related legislation and guidelines)
to competent authorities via established external channels and expert groups.
- Ensure external recognition of company as an active contributor to compendial matters
and in the shaping of Quality and GMP legislation and derived regulatory guidelines.
- Argues for testing specifications which can be met by company and defends analytical
methods from company, or others which can be cross-validated.
- Responds to incoming requests from Pharmacopoeias to company such as method testing,
batch results, delivery of reasonable quantities reference material and samples.
- Provides early information in case of important pharmacopoeial changes affecting
our products.
- Acts as help desk for interpretation of pharmacopoeial texts.
Key Skills
- The ideal candidate must have a PhD in Natural Sciences (chemistry, pharmacy or biochemistry
preferably).
- Be able to speak fluently both English and German.
- Have experience in a pharmaceutical QC and/or manufacturing and/or technical regulatory
field.
- Excellent communication skills and managing tasks cross functionally.
- Experienced in Quality Assurance and GMP.
- Have knowledge of the main Pharmacopoeias, their regulations and organisations.
