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Trading Entity Compliance QA Lead

Zurich, Canton of Zurich
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At Takeda, Quality has always been a priority for us, throughout our long history. Today, what we do in Global Quality touches every part of our diverse organization. It’s reflected in our end-to-end Quality Management System that encompasses R&D, Manufacturing & Distribution, Commercial, Vaccines and our BioLife Plasma collection network. When you’re a part of our team, you’ll do meaningful work that makes an impact on the lives of patients. Learn more about us and explore the opportunities to build a remarkable career.

Job ID R0115037 Date posted 01/31/2024 Location Zurich, Canton of Zurich

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Job Description

About the role:

  • Provide leadership in the development of policy, process and organization to ensure compliant operations

  • Perform all the duties and have all rights applicable to the Responsible Person in Switzerland as per Swiss Medic requirements

  • Primary contact for local health authorities. Own relationship/communication with the local GDP Authorities, and host External and Internal inspections in Switzerland

  • Decide on all pharmaceutical activities in scope of the License

  • Provide direction to the organization for the activities falling under the responsibility and decision making mandated by Swiss Medic

  • Ensure all requirements to maintain the Wholesale Distribution Authorisation/ Establishment license are met

How you will contribute:

Ensure compliance with:

  • Federal Act on Medicinal Products and Medical Devices (HMG SR 812.21)

  • Medicinal Products Licensing Ordinance (AMBV SR 812.212.1)

  • Ordinance on Medicinal Products (VAM SR 812.212.21)

  • Good Distribution Practice of Medicinal Products for Human Use (2013/C 343(01))

  • Falsified Medicines Directive (2011/62/EU)

  • Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products from Switzerland (Swissmedic I-SMI.TI.18)

  • Good Manufacturing Practice (Eudralex vol. 4) in line with oversight of licenced activities associated with contract manufacturing activities, as required per Swissmedic

  • Further guidance documents of Swissmedic, as applicable

  • Provide expertise in Regulatory Compliance for the products manufactured and traded by Takeda

  • The company has given authority to the Responsible Person to perform the required activities as outlined in EU GxP Guidelines.

  • Accountable to ensure GxP related activities which support Takeda’s global trading of products are compliance and efficient. 

  • Authorized to issue directives to the organization in the area of responsibility

  • Responsible for the direct technical supervision of the company under the area of responsibility and, in particular, ensure orderly trading in medicinal products

  • Ensure appropriate oversight of licenced activities associated with contract manufacturing activities as required per Swissmedic

  • Ensure that products-related GMP activities that are delegated or contracted to other Takeda sites or third party contract sites by the RP are controlled through agreements and where appropriate audits

  • Ensure deputisation by adequately qualified specialists

  • Ensure compliance to the conditions of the Wholesale Distribution Authorisation and to evolving guidelines on Good Distribution Practice (GDP) as defined by the European Commission in OJ 2013/C 343/01 and Swiss Medic’s guidelines

  • Ensure that products-related GDP activities that are delegated or contracted to other Takeda sites or third party contract sites by the RP are controlled through agreements and where appropriate audits.

These activities include:

  • Ensuring that a quality management system is implemented and maintained

  • Ensure contribution to the implementation of a quality risk management system

  • Ensure Product Review evaluation is performed in the area of responsibility

  • Ensure participation and contribution in the Management Review in the area of responsibility

  • Focusing on the management of authorized activities and the accuracy of and quality of records

  • Ensuring that initial and continuous training programmes are implemented and maintained; ensuring the conduct of following up trainings

  • Coordinating and promptly performing any recall operations for medicinal products

  • Ensuring that relevant customer complaints are dealt with effectively;

  • Ensuring that suppliers and customers are approved;

  • approving any subcontracted activities which may impact on GDP;

  • Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;

  • Keeping appropriate records of any delegated duties;

  • Deciding on the final disposition of returned, rejected, recalled or falsified products;

  • Approving any returns to saleable stock;

  • Ensuring that any additional requirements imposed on certain products by national law are adhered to.

  • Deciding independently of the company’s management and may not sit on any of the facilities’ supervisory committees.

  • Keep appropriate records and control of any delegated duties and ensure their visibility

Technical/Functional (Line) Expertise

  • Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland

  • Scientific Degree (preferably in Pharmacy)

  • Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.

  • Meets qualifications to be an Industry Certified Responsible Person (RP) in Switzerland

  • Scientific Degree (preferably in Pharmacy)

  • Strong knowledge of global regulations relating to GDP, licensing, imports/exports and controlled drug / substance compliance.

  • Previous experience as RP preferred- GDP, distribution, warehousing and transportation experience or proven equivalent experience

Leadership

  • Ideal candidate embodies Takeda's Leadership Behaviors:

  • Enterprise thinking, finding innovative ways to serve patients build reputation and trust. 

  • Focusing on the few priorities and providing superior results. 

  • Elevating capabilities for now and the future 

  • Creating an environment that inspires and enables people to move the organization forward

Decision-making and Autonomy

  • Ability to make decisions on GxP/pharmaceutical activities to ensure regulatory compliance of Takeda trading licenses and local regulatory requirements

Interaction

  • Key interactions with global and regional stakeholders including Supply Chain, Legal, Tax, BU’s, Quality. Strong partnerships and collaborations to ensure clear definition of requirements and com-pliance to the respective trading licenses.

  • Key interactions with numerous stakeholders in Quality (TE RP, OpU quality, Plant and Regional Quality, External Supply Quality)

Innovation

  • A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.

Complexity

  • Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of products

What you bring to Takeda:

  • Good Knowledge of Swiss healthcare legislation, and industry standards

  • Ability to think and act strategically and creatively

  • Ability to work successfully in multi-functional and multi-cultural teams

  • Ability to build strong relationships and key stakeholders at all levels of the organization and to influence stakeholders across diverse situations

  • Demonstrate unquestionable integrity and professionalism

  • Customer and patient orientes mindset

  • Commitment to Takeda’s values and standards

More about 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.

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.

Locations

Zurich, Switzerland

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time
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Working at Takeda

  • Inclusion

    Here, you will feel welcomed, respected, and valued as a vital contributor to our global team.
  • Collaboration

    A strong, borderless team, we strive together towards our priorities and inspiring mission.
  • Innovation

    Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
  • Top Workplace

    Recognized for our culture and way of working, we’re one of only 17 companies to receive Top Global Employer® status for 2024.
  • Work-Life

    Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
  • Empowerment

    Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.

What we believe in

Our values of Takeda-ism are Integrity, Fairness, Honesty and Perseverance, with Integrity as the core. These are brought to life through actions based on Patient, Trust, Reputation and Business, in that order.

Our belief in putting people first extends beyond our patients — it includes their families and communities, as well as our Takeda colleagues and their families.

We are committed to embracing our differences, valuing different perspectives, and fostering a culture of respect, inclusiveness and empowerment.

Our embedded Diversity, Equity & Inclusion (DE&I) strategy enables us to attract and retain exceptional talent, drives innovation, and helps address systemic inequalities in our communities.

  • Integrity

  • Fairness

  • Honesty

  • Perseverance

We're Steadfast In Our Commitment to Four Key Imperatives

Patient


Responsibly translate science into highly innovative medicines and accelerate access to improve lives worldwide.

People


Create an exceptional people experience.

Planet


Protect our planet.

Data & Digital


Transform Takeda into the most trusted, data-driven, outcomes-based biopharmaceutical company.

Exterior of Takeda Building

About our location

Zurich, Canton of Zurich


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