Head of Europe, Clinical Quality - Associate Director

Zurich
04 December | Executive po­si­tion | 100%

Head of Europe, Clinical Quality - Associate Director

Head of Europe, Clinical Quality - Associate Director

ApplySave JobJob ID R0048250Date posted Okt.. 05, 2021Location Zurich, Switzerland

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine?

Here, you will be a vital contributor to our inspiring, bold mission.

“At our heart are committed colleagues. We offer interested people numerous opportunities and strongly believe in, and promote, diversity, equity and inclusion. As a company we offer roles based on merit, welcoming candidates of any gender, age, religious belief, race or ethnic origin or disAbility. Our team is growing and for this we need bright minds with creativity and flexibility – what talent do you have?

In this role, you will contribute to Takeda’s mission by having the ability to lead effectively and work concurrently across multiple projects in a goal-oriented, timeline-driven, and dynamic work environment, while ensuring quality and accuracy. A typical day will include:

OBJECTIVES/PURPOSE:


  • Serves as the Clinical Quality Assurance (CQA) point of contact for global and local clinical studies in Europe.  Provides sponsor quality oversight of clinical development activities in Europe, ensuring that proactive quality risk management and risk based GCP audits are conducted, communicating any critical compliance risks noted from these activities to senior management, and ensuring that corrective and preventive actions are implemented.


  • Serves as a senior strategic GCP resource to Takeda for its drug development activities, and takes a lead role for the preparation, conduct and follow up, including response process, to health authority inspections of Takeda’s development activities in Europe.


  • This position provides regional leadership and strategy in Europe in line with global strategic objectives.  Collaborates with R&D Quality, Global Quality, R&D operational functions, and suppliers of outsourced services to ensure that clinical trial activities sponsored by Takeda are conducted in compliance with local regulations, Good Clinical Practice (GCP) regulations, the International Conference on Harmonization (ICH) and Takeda requirements.


ACCOUNTABILITIES: 


  • Serves as the CQA point of contact for global and local clinical studies in Europe.


  • Supports the development, implementation, and refinement of processes to ensure that Takeda maintains sponsor oversight of the quality of its development activities in compliance with applicable regulatory requirements in Europe.


  • Collaborates with the Head of R&D Clinical Quality Assurance to develop and implement the strategy for sponsor quality oversight of development activities in Europe.


  • Analyzes audit and compliance metrics to identify risks and evaluate the state of GCP compliance in Europe; presents analyses to Takeda leadership and Quality leadership and provides guidance for key stakeholders to make critical decisions.


  • This position has responsibility for the ongoing development and operational success of the CQA function in Europe.


  • Provides leadership for investigation of critical compliance issues and deviations (i.e. scientific misconduct and serious breach) in Europe and escalates as appropriate to internal and external partners, including regulators, as appropriate.


  • Escalates systemic problems and appropriate recommendations/solutions to senior leadership for immediate and long-term resolution across Europe.


  • Provides strategic direction and manages health authority GCP sponsor and investigator routine and pre-approval inspection readiness, conduct and follow-up activities for development programs in Europe, ensuring that GCP inspection commitments are fulfilled on time.


  • Collaborates with GCP Supplier Quality to evaluate acceptability of vendors for potential use by Takeda R&D as well ongoing evaluation of overall compliance performance of vendors in Europe.



  • Ensures strong alignment with other R&D Quality and relevant R&D functions requiring GCP    support in Europe.


CORE ELEMENTS RELATED TO THIS ROLE: 


  • Advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective and preventive action plans that mitigate risks to the company, specifically in the areas of patient safety and data integrity


  • Ability to effectively present information to senior management, internal stakeholders, and external partners 


DIMENSIONS AND ASPECTS:

Technical/Functional (Line) Expertise


  • Expert knowledge of GCP and understanding of Europe local and global clinical development required


Leadership


  • Possess outstanding leadership and interpersonal skills with a management style which encourages open expressions of ideas, opinions, and a full discussion of differing points of view. Sound judgment and independent initiative.


  • Ensures that every employee knows what is expected of their role and what it takes to be successful.  Helps employees grow through challenging assignments so they may realize their full potential.


Decision-making and Autonomy


  • Ability to collaborate with and achieve results through others; builds strong and sustainable relationships and interact within all levels of the organization


Interaction


  • Demonstrated ability to succinctly translate and effectively communicate the potential impact of significant and complex issues and deviations.


Innovation


  • Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.


Complexity


  • Ability to manage assignments and effectively deliver all expected deliverables in an organized and a timely manner and proactively communicate changes in pre-established goals and deadlines


Additional Information


  • 30% Travel

  • GCPA experience 8-10 years

WHAT TAKEDA CAN OFFER YOU


  • Excellent conditions & benefits including generous holidays

  • Genuine career progression and development

  • Opportunity to work with a world class leader in the pharmaceutical sector

At Takeda, we are transforming the pharmaceutical industry through our R&D- driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering Our People to Shine

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full timeApplySave Job