Trading Entity Compliance Quality Lead (Responsible Person)
Every day, employees working in Takeda’s Global Manufacturing and Supply Chain, and Global Quality business unit are shaping the future of healthcare. They are breaking down barriers and ensuring our life-changing medicines are available, accessible, and affordable to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the backbone of Takeda, and our employees are the guardians for our patients, our products, and our reputation. As a member of our team, we can offer you the opportunity to grow in a meaningful career, develop your skills, and come to work every day knowing that what you do makes a genuine difference.
What makes a successful member of our team? Check out the traits we’re looking for and see if you have the right mix.
Life at Takeda
A Global Top Employer
Recognized for our culture and way of working, we’re one of only select companies to receive Top Global Employer® status for 2019.
At Takeda, your determination and energy, combined with our cutting-edge technology and global R&D, offers families and communities hope for Better Health and a Brighter Future.
Learn more about Manufacturing, Supply Chain, and Quality careers within our global biopharmaceutical company.
At Takeda, there is an unwavering commitment to putting patients first, and to creating a workplace that is underpinned by empowerment and focused on diversity, collaboration and steadfast values.
Bold initiatives, continuous improvement, and creativity are at the heart of how we bring scientific breakthroughs from the lab to patients.
Here, you will feel welcomed, respected, and valued as a vital contributor our global team.
Through trust and respect, you will have genuine support from leaders, managers, and colleagues to do your best work.
A strong, borderless team, we strive together towards our priorities and inspiring mission.
Recognized for our culture and way of working, we’re one of only 13 companies to receive Top Global Employer® status for 2018.
Our people-first mission extends beyond patients to include their families, communities, and our own Takeda family.
Trading Entity Compliance Quality Lead (Responsible Person)Apply Now
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.
The Key Accountabilities of theTrading 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 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 Authorization are met
- 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 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 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
- focusing on the management of authorized activities and the accuracy of and quality of records
- ensuring that initial and continuous training programs are implemented and maintained
- coordinating 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
- 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
- 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)
- A strong understanding of industry and business, applicable legislation and regulatory compliance requirements.
- 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 Switzerland
- Scientific 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
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Job ID SR0039564