Cluster Quality Head, UKIE + Nordics, CQ

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• 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. This Cluster of LOCs has high complexity and/or have major global business impact requiring strong quality governance compliance focus and precise execution.
• You will ensure robust GxP compliance inspection readiness and continuous improvement while enabling business growth and transformation.
• Partnering closely with regional and global Quality leaders - and cross functional stakeholders such as Commercial Supply Chain Pharmacovigilance Medical and Regulatory Affairsyou will align local strategies with Takedas Global Quality strategic pillars and the CQ Strategy.
• You serve as the Global Quality point of contact with key Commercial Leaders & stakeholders in the Cluster and the LOC you head on quality matters and initiatives impacting the LOCs.
• Ensure that the UK/IE Quality Department provides an effective and efficient Responsible Person (RP) service for the business (LOC UK/IE) operated by appropriately qualified skilled and experienced individuals.

• Provide leadership and guidance to Quality Leaders within the cluster and team members to maintain and enhance local Quality Management strategies aligned with Takedas Global Quality strategic pillars and the CQ Quality Strategy; continuously 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 by creating an environment that allows people to thrive and move the organisation forward.
• 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 (includes selection and qualification Quality Agreements and oversight).
• Ensure there is 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 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 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 to enhance quality decision-making and operational excellence.
• 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 the below regulations / requirements. Works closely with the Quality Team and key personnel across relevant functional areas to ensure that responsibilities pertaining to the scope of the Wholesale Distribution Authorisations and Market Authorisations held by Takeda UKIE MCO legal entities (TUK and TPIL) are fulfilled.

European Union

• EU Directive 2001/83/EC on the Community code relating to medicinal products for human use;
• EU Wholesale Distribution of Medicinal Products for Human Use of EU Directive 2001/83/EC as
• amended EU Directive 2011/62/EU on Falsified Medicines;
• EU Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C
• 343/01);
• EU Good Pharmacovigilance Practices (GVP EudraLex Volume 9).

United Kingdom

• The Human Medicines Regulations 2012 UK Statutory Instruments 2012 No. 1916;
• The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 S.I. 2019/62;
• Misuse of Drugs Act 1971;
• The Misuse of Drugs Regulations 2001;
• MHRA Guidance on Pharmacovigilance procedures.

Republic of Ireland

• Medicinal Products (control of wholesale distribution) Regulations 2007 S.I. No. 538 of 2007;
• Ireland Misuse of Drugs Regulations 2017 (S.I. No. 173 of 2017);

• 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 &/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.

Base Salary Range:

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 for the position 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.

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