Director, QMS

1 week geleden

Amsterdam, Noord-Holland, Nederland Santen Inc Voltijd

[EMEA] Director, QMS & CS Quality

Full-time

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

In compliance with GxP, ISO and Santen requirements, the position holder is accountable, within the EMEA region, for leading and driving the following key cross-functional activities:

Quality Management System (QMS), including performance monitoring (KPI setting, reporting, trending), audit and regulatory inspection management, and risk management Quality governance Quality knowledge management, including training/education Quality intelligence Quality assurance activities for computerized systems (e.g. SAP, e-QMS, LMS...)

CRITERIA FOR SUCCESS

Strong co-operative skills in multinational environment Excellent organizational skills Analytical mindset, ability to solve problems and appetite for continuous improvement Ability to communicate in a concise way, internally up to Division VP and Corporate Management Team; externally with Regulatory authorities, notified bodies or other external partners Persuasive and determined, able to convince multiple stakeholders and to handle complex situations Ability to work under pressure and cope with multiple priorities Global perspective while also able to deep-dive into issues and technical details Good presentation skills Ability to work in a virtual matrix organization

Job Description

In alignment with Santen vision and with Global Quality strategy, objectives, and directions:

1. To define, standardize, implement, monitor, and continually improve the EMEA quality governance, ensuring effective and efficient framework for:

The regional Leadership commitment to Quality The management of significant quality issues (communication, decision-making, resolution...) The assessment of QMS performance and effectiveness Driving continuous improvement Discussing emerging trends The development and monitoring of resulting quality plans

2. To define, standardize, implement, monitor, and continually improve the EMEA QMS, ensuring:

All-time compliance with all applicable current regulatory expectations Robust best-in-class and standardized policies, guidelines, procedures, and models Effective and efficient roll-out across all EMEA entities

3. To lead and drive the audit (internal, external) and regulatory inspection management program, including:

Audit plan, policies, guidelines, procedures, tools, models, metrics Auditor certification/training and auditors' network coordination The assessment of audit outcomes for gap identification and the oversight of related action plans All-time inspection readiness program, providing direction, support, training and coaching for regulatory inspection preparation and management

4. To lead and drive Quality business continuity plan and risk management activities, including risk register and mitigation plan, de-risking strategies and reporting

5. To lead and drive quality assurance for computerized systems, ensuring:

GxP compliance of computerized systems, including validation aspects EMEA ownership for Quality Digital Systems (TrackWise, document management system...) Participation to the definition of the global strategy and roadmap for quality-related IT systems Implementation and monitoring of this global strategy/roadmap for the EMEA region

6. To lead and drive EMEA Quality knowledge management activities, including

The design, implementation and monitoring of an effective and efficient GxP education program, including onboarding activities The establishment of a GxP skill mapping across the EMEA Quality organization The implementation and upgrade of related modules and tools, leveraging digital technology, so that they meet expectations and customers' needs

7. To lead and drive EMEA Quality intelligence, ensuring efficient processes, tools and procedures to:

Monitor, assess any new regulation or draft regulation Identify SMEs, consolidate comments and possible action plans Where appropriate, represent Santen at EMEA industry forums/associations

8. To represent EMEA Quality in global projects related to his/her responsibilities

9. To actively participate to the EMEA Quality Leadership Team (QLT) and to lead cross-functional initiatives, proactively support other QLT members where needed

10. To lead, organize, manage, develop, and coach the team, fostering the right behaviors and mindset

11. To manage the allocated budget

Qualifications

ESSENTIAL

M.Sc. education in pharmacy, chemistry, biology, or life science. 12-15 years of Quality experience in pharma companies operating globally (EMEA, USA, Asia) Minimum 5 years of experience in a cross-functional (multi-site or regional) corporate quality role with a focus on quality systems and audits Thorough understanding of quality management system applied to manufacturing, distribution and commercial operations, and related digital tools (e.g. TrackWise, Learning Management Systems...) Strong knowledge of pharmaceutical regulations (EU and US FDA as a minimum) Experience in successfully leading cross-functional project at multi-site or regional level Extensive knowledge of ISO and worldwide GxP regulations Thorough understanding of aseptic manufacturing operations, distribution, and commercial activities Significant experience in managing regulatory inspections and interacting with authorities (EMA, FDA) Strong knowledge of risk management approaches and methods

DESIRABLE

IT additional studies Strong knowledge of medical device regulation (MDR, ISO13485) Exposure to other products and their regulations such as food supplements Intercultural sensitivity and awareness Knowledge in the use of project management tools Lean Six Sigma Green Belt certification Advanced skills in electronic quality management tools (Trackwise, Veeva Doc)

Additional Information

Grow your career at Santen

A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.

The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

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