Join us as a Quality Assurance Lead (GDP & SC, Launch & Trade Compliance) in our offices in Zurich - Opfikon, Switzerland.
OVERVIEW
The Key Accountabilities of the Quality Assurance Lead (GDP & SC, Launch & Trade Compliance) –include, but are not limited to:
Provide leadership guidance and COE expertise to the Takeda global network on supply chain and distribution quality ensuring inspection and launch readiness for TakedaProvide leadership guidance and COE expertise to the Takeda global network (Global Supply Chain (GSC), Global Manufacturing Sites (GMS), Regional Distribution Centers (RDC’s), Global Quality (GQ), LOC, and Takeda project teams) on supply chain and distribution quality topicsDevelop and support the implementation of global quality standards relating to Controlled Substance, Trade Compliance (Import/Export), and Customer/Distributor Markets across the networkDrive improvements and consistency in the quality management of Supply Chain and distribution and logistics processesCollaborate with respective parties to ensure supply /inventory management and identification of potential drug shortages and Product Lifecycle management (including divestments).Collaborate with respective parties to ensure GDP requirements are met for inspection readiness and Launch Readiness for Global Supply Chain.Maintain overview of all programs running within Commercial Quality area and report regularly to the line manager and key stakeholders as needed.DIMENSIONS & ASPECTS
Technical/Functional (Line) Expertise
Strong knowledge of Global regulations and requirements governing GDP, licensing, imports/ex-ports, controlled drug/substance compliance, and other relevant supply chain activitiesFamiliarity with different supply chain & distribution models, and associated quality oversight de-sign requirementsIn-depth understanding of end-to-end supply chain processesLeadership
Ability to collaborate and partner well at all levels, globally, regionally, & cross-functionallyAbility to lead effectively through directing change, as well as driving change through influenceAbility to lead effectively an international team, leveraging on expertise available across the net-workDecision-making and Autonomy
Solves problems whilst maintaining Takeda Quality StandardsUnderstands total potential impact and contributes significantly to the solution of simple or complex issuesUses experience to facilitate troubleshooting, and to tackle non-routine work and projects independentlyOffers constructive comments and proposes improvements and rationalizations to systems, policies and proceduresUses own judgement to assess what to refer upwards and what to manage independentlyInteraction
Key interactions with Global Supply Chain organization (Supply Chain Planning and Launch Management), BUs/Commercial and numerous stakeholder groups in Quality (OpU quality, Plant and Regional Quality, External Supply Quality, LOC QA) for alignment and implementation of global supply chain quality initiatives and projects including launches, controlled substances, and import/export.Innovation
A strong grasp of industry trends and emerging regulations; leverages innovation and benchmarking of industry best practices in supply chain & distribution quality to advance the GQ RoadmapComplexity
Multiple countries and business units, complex mix of supply & distribution models, multiple regulatory frameworks and a wide diversity of productsEDUCATION, BEHAVIOURAL COMPETENCIES & REQUIRED SKILLS
Scientific degree (BSc, MSc)>8 years of experience in the biotechnology and/or pharmaceutical industry, preferably bothStrong knowledge of regulations governing pharmaceutical supply chain and distribution.Strong knowledge of controlled substance managementStrong interpersonal skills including excellent communications; adept at influencing and negotiating to lead formal and informal teams in a global environment.Fluent in written and spoken English.Working in a multinational organization effectively navigating differing regional expectations and regulationsOTHER REQUIREMENTS
International Travel will be required to facilitate robust partnerships and execution. Depending on growth of organization and the primary work location, travel is estimated to be between 15% and 20%.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