At Astellas we are making treatments that matter to people We are tackling the toughest health challenges putting the patient at the heart of every move we make. We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked. We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives. From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

Senior Director, Quality Operations QAE, Quality Operations

Location: Surrey, (UK) or Leiden (Netherlands)

Leads team of 8 across EMEA; 5 CMO QA, 2 Supply Chain QA, 1 Artwork QA.

Purpose and scope:

As part of the Global Quality Operations team you will be responsible for pproviding regional leadership and strategic direction for Quality Assurance aspects related to Product Quality Management (PQM), EMEA and also representing regional PQM at global level.  As well as leadership and support for EMEA (3) Astellas Manufacturing sites, (approximately 60) third party contract management and Supply Chain organisation ensuring compliance to GMP/GDP Regulations, Directives, and Guidelines whilst driving continuous improvement through the implementation of best practices, managing any significant quality issues including recalls to bring situations under immediate control and prevent recurrence.

Essential Job Responsibilities:

1. Acts as PQM Head for EMEA region and provides for leadership of the EMEA PQM responsibilities.

1. Provide leadership to EMEA Product Quality Management team to provide continuous operational oversight of all GMP and GDP activities whilst ensuring that EMEA interests are reflected appropriately at global corporate level.  Manage and coordinate any significant quality issues including recalls to bring situations under immediate control and prevent recurrence through continuous improvement activities. Review, advise, implement and maintain the Quality Systems of the EMEA Plants, CMO and Supply Chain Systems to ensure compliance with GMP/GDP regulations.

1. Liaising with a variety of internal (e.g. Technology, PV, RA, R&D etc.) and external stakeholders (e.g. European Health Authorities, PDA, ABPI etc.) to propose new policies and/or operating procedures to ensure best practices are implemented across plants, contract manufacturing and Supply Chain organisations. 

1. Develop and improve performance of PQM EMEA team.  Build a strong organization.

1. through coaching and developing subject matter expertise in quality operations.

1. Responsible for facilitating strategic communications with senior management with focus on delivering actions as applicable. Continuously gain an external understanding of developments within Pharma through attendance of industry trade bodies and conferences.  Assimilate and distribute this information to all key stakeholders to ensure proactive compliance of new GMP/GDP guidelines at Plants and CMOs. Daily monitoring and/or operational support the Supply Chain function handling Artwork/Text and Master Data management.  Support regional QA affiliate cluster leads on a daily basis. 

1. Establish and maintain a reliable Quality Assurance system for third party products and supplies (e.g. management of product maintenance & change control, Technical Agreements, complaints & recalls, and product release to the market).

1. Hold EU Region QA conferences and ensure deliverance of value-added agenda and management of meeting outcomes.

Qualifications required:

• Science based degree (pharmacy preferred).
• Demonstrated relevant further education achievement, e.g. Eligibility for QP, Lean Sigma black belt and/or MBA qualification.
• Member of professional bodies and/or associations

Skills and experience required:

• Proven, robust and demonstrable understanding of Global GxP requirements including EU Directives and EU GMP.
• Subject matter expert / specialist of at least two product types.
• Extensive knowledge acquired through progressively senior roles in complex environment in senior manufacturing GMP pharma roles and/or regional QA role (advantageous if experienced in both).
• Able to complete accurate, compliant and decisive QA related actions to support and maintain Astellas reputation and protect patient safety. Ability to identify and mitigate risk.
• Significant proven track record of achievements in senior roles including management of virtual and remote teams, cross cultural working and developing future talent.
• Proven track record of having lead GxP audits and resulting recommendations / reporting..
• Significant proven Global impact project exposure across multiple territories including virtual.
• Involvement in External Association activities e.g. ABPI, EFPIA, ISPE, JPB etc. and extensive networking experience.
• Maintains and builds currency of expertise and promotes best practice, knowledge sharing and compliance.
• Consistent demonstration of Astellas Senior Leader Competencies to command the respect of senior leaders and stakeholders.
• Makes substantial contributions to QAE, able to execute and lead others to deliver strategic plans. 
• Ability to identify and develop future QAE talent and create pipeline of future leaders.
• Strong project management capability (project planning, control, risk management, resource planning, budgetary controls, change etc.). 
• Strong interpersonal skills including cross-cultural working and diversity.
• Good organizational, coordination, diplomatic, negotiation, presentation and communications skills.
• Politically astute and highly respected professional.
• Communication - clear exposition of regulations and appropriate alternatives and recommendations. Good communication skills, both written and spoken, are necessary including report writing, meeting facilitation and presentations. Fluency in written and spoken business English.
• Full availability during business hours to respond to significant quality issues including flexibility for significant issues which may arise from time to time outside normal working day.

We offer

·         A challenging and diversified job in an international setting

·         Good career opportunities

·         Inspiring work climate

·         Attractive remuneration package