Jobbeschreibung

Positionsnummer / Reference Number

PA1205224022021

Position / Job Title

Head Quality Management (Responsible Person FvP)

Aufgaben / Tasks

• Quality management of supply network
o Qualify, evaluate and supervise suppliers, logistics service providers and CMOs
o Conduct audits and support inspections at suppliers, logistics service providers and CMOs
o Establish appropriate Quality Agreements
o Establish appropriate Quality Oversight principles for the contracted services
o Host customer audits
o Review of quality related documentation issued by CMOs
o Assess and coordinate release activities with release sites
o Ensure quality and regulatory compliance to the registered dossier, including and not limited to change management
• Quality Management System
o Maintain Quality Management Systems for the Bioeq AG organisation and ensure compliance with the regulatory applicable local and global requirements
o Prepare, review and maintain SOPs
o Manage deviations, CAPAs, changes and complaints
o Maintain and improve Bioeq’s quality training system
o Validate systems and processes
o Perform internal audits
• Coordination with authorities
o Ensure that the required HA licenses and GxP certifications are in place and up to date
o Host inspections by authorities
o Communicate with authorities within the scope of a Responsible Person

Qualifikationen / Qualifications

• University diploma / state examination in pharmacy or other natural sciences
• Proven track record of 5+ years in pharmaceutical industry internationally with at least 4 years GMP/GDP experience in a quality function, preferably as Responsible Person
• Sound knowledge of GMP/GDP, quality system requirements, as well as biopharmaceutical, Swiss and international (EU, US) pharmaceutical regulations
• Ideally trained as auditor and experience in supplier and CMO oversight and audits
• Fluent in both English and German

Weitere Informationen / Further Information

You will act as Responsible Person and be responsible for a GxP-compliant pharmaceutical QMS and for coordinating quality across our supply network to ensure safety, efficacy and quality of the products delivered to our global partners.

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