[EMEA] Regional Head, Quality Assurance

Company Description

Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world. 

Purpose of Role

• As a key partner to the business, the Head of Quality Assurance for EMEA (HQA) is responsible for setting the appropriate standards and programs of quality for the products that will be delivered to patients in EMEA
• The HQA scope involves the research, manufacturing and distribution quality-related activities of pharmaceutical and medical devices products in EMEA
• The HQA ensures the design and implementation of the appropriate Quality Management Systems in compliance with the GxP and other applicable regulations in the EMEA territories
• The HQA also participates in and contributes to the global quality assurance activities of Santen

Job Description

• Lead and develop the EMEA QA personnel, ensuring the prioritization of activities, objectives setting, regular upskilling and performance management as well as their career development
• Ensure compliance with current Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs) and more generally all activities involving Santen pharmaceutical or Medical Device products (GxPs). Take all initiatives or actions needed to ensure compliance with applicable regulatory requirements
• Develop Medical Device Quality Management Systems, programs, policies, specifications, methods and procedures in EMEA territory and control their implementation in line with applicable regulations (Medical Device Regulation, ISO13485, etc.)
• Develop Medical Drug Quality Management Systems, programs, policies, specifications, methods and procedures in EMEA territory and control their implementation
• Validate product quality compliance to established standards and agency guidelines and support timely release of commercial and clinical products and CMO operations
• With a view to supporting the quality of products manufactured or distributed by third parties, the HQA will develop metrics, quality control tools & processes to support the selection or regular business reviews of CMOs and other third parties
• Lead or coordinate internal and external compliance audits as required. Ensure audits are conducted on a timely and regular basis to ensure the quality compliance of outsourced manufacturing and distribution
• Work in cross-functional teams to ensure the constant enhancement of QA programs and state of the art practices for medical devices and medical drugs
• Support the quick resolution of quality or compliance issues that require an in-depth knowledge of operational and regulatory requirements for medical devices and medical drugs. Inform the business leadership of quality or compliance issues that could have major impact to the company and the corrective actions plan
• Act as a trusted partner and maintain good relationships with regulatory agencies as required

Qualifications

EDUCATION

Essential

• Minimum Master's Degree (MSc) or PhD (of advantage)
• Demonstrates in-depth knowledge of QA principles, concepts, industry practices, and standards.
• Demonstrates in-depth knowledge of EMEA regulatory requirements (GMP, GLP, GDP, etc.)

Desirable

• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations
   

EXPERIENCE

Essential

• Experience with commercial products, sterile products and medical devices is mandatory
• 15+ years of experience in a quality assurance function with prior people management experience
• Successful experience of managing a multinational team

Desirable

• Working knowledge of Risk Management tools HACCP or FMEA
   

OTHER / FUNCTIONAL COMPETENCIES

Essential

• Demonstrates excellent verbal, written and interpersonal communication skills
• Must be goal oriented and quality focused with a good business acumen
• Can handle conflicts by quickly finding common ground and get cross functional cooperation to achieve resolution
• Excellent English skills

Desirable

• Demonstrates understanding of Computer Systems Validation and ICH Guidelines
• Demonstrates knowledge of Six Sigma, performance measures and quality improvement
• Knowledge of ophthalmology is a plus