About the role:
As a core member of the Region Europe / CAN Commercial Quality Leadership Team, you provide leadership, guidance and lead a network of Cluster UK/IE and Nordics Quality Leaders across Local Operating Companies (LOCs), while also implementing it for the LOC you lead (UK/IE) in your dual role as LOC CQ Head UK/IE.
You will ensure robust GxP compliance, inspection readiness, and continuous improvement while enabling business growth and transformation.
How you will contribute:
- Provide leadership and guidance to Quality Leaders within the cluster and team members to maintain and enhance local Quality Management strategies aligned with Takeda's Global Quality strategic pillars and the CQ Quality Strategy.
- Ensure successful delivery of business strategy, Key Performance Indicators (KPIs) and GQ objectives in adherence to quality & regulatory compliance.
- Manage GxP regulated activities in partnership with the Regional CQ Leaders, including in country distribution quality, local Health Authority relationships, local quality surveillance, and in country clinical and medical device activities.
- Implement Supplier Quality Program in the LOCs using a lifecycle management approach for local GxP suppliers (includes selection and qualification, Quality Agreements, and oversight).
- Lead or support timely Health Authority communications on product quality and compliance issues, and drive resolution and escalation of product quality and compliance issues affecting LOCs across the Cluster.
- Lead regulatory surveillance and intelligence in the LOCs for new or emerging regulations, providing guidance and support for inspection readiness.
- Drive quality capability-building and improvement programs across the Cluster, including quality risk management, compliance education, and digital quality initiatives.
- Lead cluster-wide quality transformation initiatives to strengthen compliance with Takeda QMS and local regulatory requirements, and embed a strong quality culture across LOCs.
Regulatory scope:
Ensure compliance with EU Directive 2001/83/EC, EU Directive 2011/62/EU on Falsified Medicines, EU Guidelines on Good Distribution Practice, EU Good Pharmacovigilance Practices, The Human Medicines Regulations 2012, Misuse of Drugs Act 1971, The Misuse of Drugs Regulations 2001, MHRA Guidance on Pharmacovigilance procedures, and Irish Medicinal Products (control of wholesale distribution) Regulations 2007 for Takeda UKIE MCO legal entities.
Minimum Requirements/Qualifications:
- Scientific degree (BSc, MSc) in Pharmacy, Life Sciences, Engineering, or related field (or equivalent experience).
- At least 15 years of increasing management responsibility in the pharmaceutical industry including Quality Assurance, combined with a strong knowledge of regulations pertaining to pharmaceutical manufacturing and distribution in the region.
- In-depth knowledge of global pharmaceutical operations, supply chain / distribution management, CMO management, Quality.
- Proven track record to lead & manage in highly complex and/or high business-impact environments, coordinating diverse teams and stakeholders across multi-faceted topics.
- Ability to lead teams in a multicultural environment with remote teams and stakeholders, including managing and leading by influence and conflict management.
- Demonstrated experience leading cross functional initiatives and transformation programs; strong influence and stakeholder management skills.
- Data and digital fluency (e.g., metrics, dashboards, analytics, automation) to enhance decision making and efficiency.
- Fluent in written and spoken English.
Locations: London, Great Britain
Base Salary Range: £92,800.00 - £127,600.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Worker Type: Employee
Worker Sub-Type: Regular
Time Type: Full time
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Cluster Quality Head, Uk/Ie + Nordics employer: Takeda
At Takeda, we pride ourselves on being an exceptional employer that fosters a culture of collaboration and innovation. As a Global Medical Excellence Lead based in the UK, you will benefit from a supportive work environment that prioritises employee growth through continuous learning opportunities and impactful projects. Join us to make a meaningful difference in healthcare while enjoying a dynamic workplace that values your contributions and encourages professional development.
