Join us as a Trading Entity Compliance Quality Lead (Responsible Person) in our offices in Switzerland. This position is initially based in Zug and will move to Zurich Opfikon later this year.

OVERVIEW

The Key Accountabilities of the Trading Entity Compliance Quality Lead  (Responsible Person) include, but are not limited to:

Provide leadership in the development of policy, process and organization to ensure compliant operationsPerform all the duties and have all rights applicable to the Responsible Person in Switzerland as per Swiss Medic requirementsPrimary contact for local health authorities. Own relationship/communication with the local GDP Authorities, and host External and Internal inspections in SwitzerlandDecide on all pharmaceutical activities in scope of the LicenseProvide direction to the organization for the activities falling under the responsibility and decision making mandated by Swiss MedicEnsure all requirements to maintain the Wholesale Distribution Authorization are met

Accountabilities, continued:

Provide expertise in Regulatory Compliance for the products manufactured and traded by TakedaThe company has given authority to the Responsible Person to perform the required activities as outlined in EU GDP Guidelines.Accountable to ensure GxP related activities which support Takeda’s global trading of products are compliance and efficient.Ensure compliance to the conditions of the Wholesale Distribution Authorization and to evolving guidelines on Good Distribution Practice (GDP) as defined by the European Commission in OJ 2013/C 343/01 and Swiss Medics guidelinesEnsure 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 maintainedfocusing on the management of authorized activities and the accuracy of and quality of recordsensuring that initial and continuous training programs are implemented and maintainedcoordinating and promptly performing any recall operations for medicinal products o 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 program 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; o approving any returns to saleable stock;ensuring that any additional requirements imposed on certain products by national law are adhered to.Keep appropriate records and control of any delegated duties and ensure their visibility

DIMENSIONS & ASPECTS

Leadership

Ability to collaborate and partner well at all levels, globally, regionally & cross-functionally.Highly punctual, systematic, highly organized, & concise in communicationStrong attention to details, ability to review & managing documentation

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 compliance 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

EDUCATION, BEHAVIOURAL COMPETENCIES & REQUIRED SKILLS

Meets qualifications to be an Industry Certified Responsible Person (RP) in SwitzerlandScientific Degree (preferably in Pharmacy)Strong knowledge of global regulations relating to GDP, licensing, imports/exports and con-trolled drug / substance compliance.Previous experience as RP preferred- GDP, distribution, warehousing and transportation experience

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. Discover more at takedajobs.com.  

What Takeda Can Offer You

To further support and inspire our employees, our benefits include: Competitive basic salary, Annual Bonus, Long Term Incentive Plan, Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com