As Manager External Supply Quality Assurance (ESQA) you will actively contribute to enhancing the quality of the company’s products through quality management of outsourcing activities, and assessment of suppliers. You will be developing relationships internally and externally, independently negotiating Quality/regulatory issues, developing and communicating quality requirements with contract manufacturers and licensees.
•You will have Contractor Management responsibilities in ensuring contractors have applicable quality systems and comply with GMP/regulatory requirements and the company’s expectations, Change Control, Deviation Management, Market actions, Lot Approval, Complaints management, Annual Product Reviews, Stability Surveillance, Validation Approval, Audit support, Quality System Support, Metrics
•You will have responsibilities linked to New Product Introduction (NPI): give quality input in the selection, audit and evaluation of contractors, support the co-development initiatives for Quality and Compliance for contractor-related activities, carry out due diligence Quality audits including follow-up of CAPA closure
•You will have responsibilities in Product transfers (PNS): you will act as QA support to Product transfer teams, advising them on the company’s expectation regarding the quality and you will supply QA approvals as required of the Transfer Plan.
•Your responsibilities in the Regulatory area will be to support Regulatory compliance assessment at contractors, support the process for Manufacturing Authorization renewals, act as QA focal point for regulatory communications and changes.
•You will have responsibilities in the Contract Process: you will develop, negotiate and coordinate the Quality Agreement, when required initiate Technical agreements between ESQA and markets, facilitate Pharmacovigilance agreements.
•You will actively participate in the development and implementation of ESQA Guidelines and policies by continuous maintenance of the ESQA Quality System, by ensuring a consistent approach to the interpretation and implementation of GxP standards and the company’s expectations and participating in Coordination of annual GCQA audit schedule for contractors
•You will follow-up the KPIs to ensure there are no regulatory issues with manufacturers and the company’s plants, timely identification and resolution of quality and regulatory issues at a manufacturer and to guarantee a high-level quality standard at contractors, according to GMP or other appropriate product standards
•You have a Bachelor/Master degree in Pharmaceutical Science, Microbiology, Chemistry or equivalent
•You can prove minimum 9 years management experience in the Pharmaceutical industry with at least 6 years in QA/QC type roles supporting commercial pharmaceutical operations, ideally in a production QA support, technical manufacturing projects or release roles
•You are Fluent in English and ideally, have knowledge of other European languages
•You have advanced user-level of MS Office applications
•You demonstrate knowledge of a range of products and regulatory requirements in the diverse portfolio of products (ideally Animal Health).
•You have strong negotiation and communication skills
•You demonstrate potential to manage multiple projects, to prioritize own work, to act and work independently and to report items as required to Team leader.
•You demonstrate experience with managing complex quality and compliance activities in a manufacturing plant or with a contractor.
•You have strong potential of personal leadership to manage cross-functional projects.
•You demonstrate the ability to resolve conflicts.
•You take initiatives, are proactive, persistent and pursue to closure
•You are diplomatic in communication with internal and external customers.
•You are customer oriented and willing to travel up to 20 %.