Bausch & Lomb
Warsaw, Poland
Purpose of the job:
- The Quality & Wholesale Manager manages and supervises the work of a pharmaceutical wholesale warehouse. Supervises warehousing activities and product turnover according to requirements specified in a license for running a pharmaceutical wholesale and applicable regulations of law. Establishes and maintain a Quality Management System in a pharmaceutical warehouse according to good practice, requirements, domestic and international regulations, directives and decrees. Establishes internal work organization;
- The Quality & Wholesale Manager has overall responsibility for the quality system and leadership of the site quality organization at Valeant Logistics Center located in Myslowice, Poland. He/she is a member of the leadership team in Poland and will sponsor a quality and compliance focused culture which embraces RFT (right first time) and CI (continuous improvement) expectations;
- The Quality and Wholesale Manager will develop and maintain a site quality system which allows for the timely supply of goods and which meets Valeant’s’ and legal requirements. Next to this he/ she will develop and monitor quality improvements and validation activities. The Quality and Wholesale Manager act as the Qualified Person for the Myslowice Distribution Site according to Polish Pharmaceutical Legislation;
- The Quality and Wholesale Manager is the expert on quality and compliance and will provide input and support for the local Quality Strategies. Manage the QA team at the Myslowice Distribution Center. Responsible for Quality Agreements with 3PL providers in assigned countries. Perform various quality control functions (receiving, in-process inspection, change control, document control, CAPA management, validation, training, product final release, and complaint evaluation) in the Myslowice logistics site. The Quality manager should work with claims of the customers, devoted either to the quality of the product, including storage and transportation.
Structure and reporting lines:
The Quality and Wholesale Manager reports to the QA Distribution leader EMENA (Amsterdam) and has a dotted line to the Supply Chain Director in Poland. The Quality manager will manage a team of two persons in close collaboration with external parties.
The Individual
Education and Experiences Criteria:
- Bachelor of Science Degree in Engineering or Related Science Field or equivalent;
- Education with pharmaceutical background is an advantage (pharmacist);
- Fluent in English;
- 5+ years’ experience working in the Quality Assurance field, as well as, experienced Qualified Person (QP) working with FDA and EU Medical Device Directive (MDD), ISO 13485, GMP, GDP and Pharmaceutical Quality System Regulations (= a must!);
- QA experience within logistics or warehousing/distribution environment in Medical devices or Pharma industry;
- Certified ISO lead auditor is seen as an advantage;
- Deep expertise and knowledge of pharmaceutical local regulations in Poland, including knowledge of production processes, registration, quality assurance, EU Pharmacopeias;
- Proven communication, leadership and technical skills. Understanding of GMP, GDP, and ISO 13485 requirements and the mechanisms to influence, as well as, successful interactions with regulatory agencies;
- Knowledge of management of Quality operations and processes.
Personality criteria:
- Project management, technical writing ability and computer skills are required;
- Strong analytical and problem solving skills especially in non-conformance investigations. Ability to assertively interact with people at all levels of the organization. Ability to manage multiple priorities;
- Demonstrated ability to work independently;
- “Can do” attitude;
- Proven people management skills, team builder, strong stakeholder management skills and motivator.
Job Travel Requirements:
- 15% Domestic, 5% Foreign.