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About the Role

As a core member of the Region Europe / CAN Commercial Quality Leadership Team, you will provide leadership and guidance to Quality Leaders across the UK/IE and Nordics clusters. You will ensure robust GxP compliance, inspection readiness, and continuous improvement while enabling business growth and transformation. You will partner closely with regional and global Quality leaders and cross-functional stakeholders to align local strategies with Takeda’s Global Quality strategic pillars and the CQ Strategy. You will serve as the Global Quality point of contact for key Commercial Leaders and stakeholders in the Cluster and the LOC you head on quality matters and initiatives impacting the LOCs. You will ensure the UK/IE Quality Department provides an effective and efficient Responsible Person (RP) service for the business.

Responsibilities

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.
Seek efficiencies and innovative approaches to improve processes and outcomes.
Provide leadership, guidance & technical expertise to LOCs in the Cluster on quality matters, driving a high-performance culture and development of the team.
Ensure successful delivery of business strategy, Key Performance Indicators (KPIs) and GQ objectives in adherence to quality & regulatory compliance.
Foster strong cross functional collaboration with key stakeholders that prioritizes patient needs, regulatory compliance, safety, and continuous improvement.
Drive innovative change and support business transformation.
Manage GxP regulated activities in partnership with the Regional CQ Leaders, including in country distribution quality, local Health Authority relationships, local quality surveillance, local contract manufacturing/packaging/analytical testing quality oversight, and in country clinical and medical device activities.
Serve as strategic quality business partner and maintain strong relationships with Commercial, Supply Chain, Pharmacovigilance, Medical, and Regulatory Affairs.
Implement Supplier Quality Program in the LOCs using a lifecycle management approach for local GxP suppliers.
Ensure quality oversight of local GCP/GVP/Devices/Medical related activities under CQ responsibility.
Lead or support timely Health Authority communications on product quality and compliance issues, ensuring proper execution within the cluster by the appropriate CQ Lead.
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 and ensure coverage and response across the cluster.
Provide guidance and support inspection readiness of LOCs in the cluster to maintain a favorable regulatory profile with Heath Authorities.
Partner with GPP and Cluster/local stakeholders to operationalize Global Product Protection strategies within the Cluster/LOC ensuring supply chain integrity and embedding product protection into the quality system.
Ensure self-inspections are performed to monitor compliance with applicable procedures and requirements.
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 sustainability, compliance with Takeda QMS and local regulatory requirements, and embed a strong quality culture across LOCs through continuous improvement and best-practice adoption.
Ensure compliance with EU and UK regulations including EU Directive 2001/83/EC, EU Guidelines on Good Distribution Practice, EU Good Pharmacovigilance Practices (GVP), The Human Medicines Regulations 2012, and MHRA Guidance on Pharmacovigilance procedures.
Ensure responsibilities pertaining to the scope of the Wholesale Distribution Authorisations and Market Authorisations held by Takeda UKIE MCO legal entities are fulfilled.

Requirements

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.
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 &/or high business-impact environments, coordinating diverse teams and stakeholders across multi-faceted topics to deliver successful & sustainable outcomes.
Ability to lead teams in a multicultural environment with remote teams and stakeholders.
Experience includes successful examples of 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.

Skills

Quality Assurance
GxP compliance
Inspection readiness
Continuous improvement
Quality governance
Regulatory compliance
Stakeholder management
Supply chain management
Pharmacovigilance
Regulatory Affairs
Risk management
Product protection
Data analysis
Digital transformation

Location

London, Great Britain

Work Type

Employee
Regular
Full time

Experience Level

At least 15 years of increasing management responsibility

Education Level

Scientific degree (BSc, MSc) in Pharmacy, Life Sciences, Engineering, or related field (or equivalent experience)

Salary/Compensations

£92,800.00 - £127,600.00

Benefits

For information about our benefits, please click here.

About the Company

Takeda is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments.
Takeda focuses on four therapeutic areas: Oncology, Rare Diseases, Neuroscience and Gastroenterology (GI) as well as Plasma-Derived Therapies and Vaccines.
We are driven by our patient-centric values and our commitment to making a difference in the lives of patients worldwide.

Equal Opportunity

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