The Associate Director Quality has the overall responsibility for planning, budgeting, resource management and direction of the quality function for all out licensing agreements for Medis. The incumbent must be capable of establishing sustainable and collaborative relationships with internal and external customers.
The Associate Director Quality is a Medis Responsible Person and a Qualified Person and is consequently responsible to ensure compliance with Good Distribution Practice (GDP) guidelines and current Good Manufacturing Practice (cGMP).
Duties and responsibilities
- Ensure GMP & GDP compliance at the commercial unit and promote quality culture
- Create, maintain up-to-date and distribute Standard Operating Procedures and Working Instructions as per Teva standard and in compliance with national regulations
- Ensure GMP and GDP training at a local level
- Lead Local Cross functional Quality Council
- Ensure quality complaints are registered and liaise with manufacturing site to trigger corresponding investigation and adequate corrective actions. Liaise with pharmacovigilance department if necessary
- Administer, maintain and develop systems for change control, deviation and CAPA handling
- Maintain and monitor a list of approved suppliers/customers/providers
- Ensure Quality Agreements are drawn up and kept updated with all local suppliers/customers and 3rd party service providers as required
- Host local authorities inspection
- Manage and lead Commercial Quality Units team members
- Master´s Degree in Pharmacy, Medicines, Biology or an equivalent combination of education and experience to the functional role
- Post-graduate or Doctoral degree in Pharmacy, Medicines, Biology or similarly related fields of specialization would be an advantage
- Proven experience as a Quality Manager/QP in a pharmaceutical company or importer/distributor
- Demonstrated knowledge and working experience with government regulations for the country
- In-depth knowledge of pharmaceutical industry as it relates to Quality Compliance
- Working knowledge of pharmaceutical operations.
- In-depth understanding of cGMP & GxP's regulations
- Experience with development and implementation of Quality Systems and application of risk assessment tools
- Proficient computer skills in current software including MS Office