GDP Quality Lead

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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?”

MORE ABOUT TO US:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

OBJECTIVES/PURPOSE

• This role performs the operational quality oversight of and provides guidance to Global and Regional Distribution Centers (GDC/RDCs) in Europe.
• The responsibilities cover quality aspects of warehousing, distribution and transportation as well as the management of quality and compliance issues of GDC/RDCs
• This role is the direct contact point for local affiliates, manufacturing sites and external supply groups for GDC/RDC quality related matter.

ACCOUNTABILITIES

• Drive and ensure timely resolution of product quality & compliance issues in the assigned RDCs, in compliance to Takeda QMS and local regulatory requirements including complaints/ recalls, investigations and audit related
• Responsible for notification and escalation of severe GDP events to Takeda management
• Drives risks identification and mitigation for processes linked to and established at the GDC/RDCs.
• Ensure compliance to change management requirements at the GDC/RDCs and adequate translation into the Takeda QMS.
• Ensure compliance to Falsified Medicines Directive of the GDC/RDC(s)
• Perform and/or support GDP Audits at GDC/RDCs.
• Represents Takeda during regulatory agency inspections at GDC/RDCs. Provides support for inspections at Takeda manufacturing sites related to questions for GDC/RDC
• Evaluate the level of GMP/GDP compliance and risks for products managed by GDC/RDCs in the region through key performance indicators/quality performance indicators and drives the implementation of improvement activities.
• Participate in supporting recall activities, as needed
• Maintain strong collaboration with Supply Chain, Site Quality Organization, GDC/RDC related LOC Quality and Takeda project teams.
• Establish or support the establishment of Quality Agreements related to GDC/RDC’s
• Process and/or administrate Quality Assurance information in Takeda electronical systems e.g. SAP, JDE, EQMS, LEADs and other electronic systems.

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

• Strong knowledge of regulations pertaining to GDP, distribution, warehousing and transportation in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
• Understanding of Commercial Quality requirements, including regional and in-country distribution, controlled substance compliance, supply chain quality, and local quality surveillance (re-turns, recalls, complaints).

Leadership

• Ability to collaborate and partner well regionally & cross-functionally with Takeda stakeholder groups and GDC/RDCs
• Ability to drive change by influence

Decision-making and Autonomy

• Represent Takeda to make decisions on acceptability of distributor’s and warehouse operations quality programs and daily GDC/RDC related activities

Interaction

• Key interactions with GDC/RDCs in region to improve performance & maintain compliance
• Interactions across manufacturing and site and regional quality teams to enable timely issue resolution

Innovation

• Understanding of quality and regulatory requirements and trends related to warehousing and distribution in Europe

Complexity

• Multiple countries, supply & distribution models, regulatory frameworks and diversity of products

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Scientific Degree (BSc, MSc)
• Minimum 7 years experience in in the pharmaceutical industry including Quality Assurance, combined with a good knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region (e.g. familiar with cGMP/GDP, ISO and ICH requirements)
• Strong attention to details, ability to review & managing documentation (including transport temperature records, shipping documents, and related GDP documents/ records etc.)
• Prior experience managing external GMP/GDP suppliers
• Skilled at leading GMP/GDP audits
• Fluent in written and spoken English

Core Competencies / Skills

• Critical Thinking
• Investigation and problem solving
• Strong communication and interpersonal skills including listening, judgment and conflict management appropriate for regional and international collaboration
• Risk identification, evaluation and management
• Ability to work effectively across different functions
• Striving and implementation of continuous improvement

Leadership Behaviors

• Enterprise thinking, finding innovative ways to serve patients build reputation and trust
• Creating the environment that inspires and enables people
• Focusing on the few priorities and provide superior results
• Elevating capabilities for now and the future
• Takes an optimistic and constructive stance when challenges arise and driving solutions

ADDITIONAL INFORMATION

• Domestic and international travel will be required (up to 25%)

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
• A dynamic and inspiring working environment.
• Opportunities to work on challenging projects and assignments.

EMPOWERING OUR PEOPLE TO SHINE:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.

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