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Senior Quality Manager / Deputy Responsible Person

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Job ID R0048048 Date posted Sep. 30, 2021 Location 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

  • Eligible to perform all the duties and have all rights applicable to the Deputy Responsible Person in Switzerland as per Swiss Medic requirements
  • Provide direction to the organization for the activities falling under the responsibility and decision making mandated by Swiss Medic
  • Support in the development of policy, process and organization to ensure compliant operations
  • Execute daily activities associated with implementation and maintainance of the QMS supporting activities of the trading entity team.

ACCOUNTABILITIES

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
  • Decide on all pharmaceutical activities in scope of the License
  • 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
  • Primary contact for local health authorities. Own relationship/communication with the local GDP Authorities, and host/support External and Internal inspections in Switzerland
  • Execution of all daily QMS activities such as but not limited to:
    • write, review and approve SOPs as required
    • Implementation, execution and administration of change control, deviation & CAPA’s
    • Ensure that accurate records, as required by the individual elements of the QMS, are kept and maintained in a secure manner

DIMENSIONS AND ASPECTS

Technical/Functional (Line) Expertise

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

  • Ability to collaborate and partner well at all levels, globally, regionally & cross-functionally.
  • Highly punctual, systematic, highly organized, & concise in communication
  • Strong 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 AND SKILLS:

Critical Skills and Competencies

  • 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 oriented mindset
  • Commitment to Takeda’s values and standards

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 time
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