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Quality Manager

Apply NowEmail Me Job ID R0028068 Date posted 01/14/2021 Location: London, United Kingdom; Paddington, United Kingdom

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Job Description

Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda.

Summary

The Quality Manager will lead and manage the resources of the Quality Department in order to:

•            Ensure that Quality Management Systems covering the Takeda UK and Ireland Multi-Country Organisation (MCO) are maintained and function effectively, meeting all internal (eg Global Quality) and external (eg MHRA / HPRA) requirements

•            Ensure that the Quality Department provides an effective and efficient Responsible Person (RP) service for the business, operated by appropriately qualified, skilled and experienced individuals

•            Champion a ‘quality mindset’ across the MCO, promoting a good understanding of the concept of quality and the responsibility of all employees to contribute towards the organisation’s quality objectives

•            Recruit, train and develop talent within the Quality Department, ensuring that all employees have appropriately stretching objectives in place, along with development plans aligned with their career aspirations

Key Accountabilities

  • Develop and maintain detailed knowledge of internal and external Quality requirements, including those pertaining to GxP, PV and commercial activities
  • Ensure the business continues to meet it’s obligations to regulatory authorities as a Marketing Authorisation Holder (MAH)
  • Oversee an in-house RP service for the UK / Ireland MCO
  • Ensure that all relevant licenses required for the distribution of drugs are maintained (eg Wholesale Dealers Authorisation (WDA), controlled drugs licenses)
  • Responsible for the Takeda UK / Ireland Quality Management System (QMS), covering both GxP and non-GXP activities, specifically:
  • Ensure compliance with Global Quality Principles, Standards and Policies
  • Ensure effective operation of the QMS including change controls, deviations, risk assessments and CAPAs
  • Approval of documents used within the QMS
  • Ensure adequacy of MCO-level SOPs
  • Ensure adequacy of self-inspection activities
  • Prepare and maintain MCO-level Standard Operating Procedures (SOPs) relating to Quality department activities and ensure these are effectively trained out to relevant employees
  • Ensure effective operation of learning management systems covering both GxP and non-GxP areas of the business, including maintenance of a training matrix allocating appropriate training against specific roles across the business
  • Actively seek to minimise risks to the business, manage identified risks and alert senior management to any underappreciated risks
  • Represent the Quality Department at Quality Council meetings, ensuring that all significant Quality issues are appropriately communicated to senior management within the UK / Ireland MCO
  • Drive an ongoing programme of continuous improvement aimed at improving both quality and efficiency
  • Ensure that they Quality Department is consistently audit / inspection-ready
  • Play a leading role in preparation for and support of internal and external audits within the MCO
  • Oversee audits required for high risk vendors (providing both GxP and non-GxP services) and pre-wholesalers
  • Review and approve of Quality/Technical Agreements with Suppliers, Manufacturers and Pre-wholesalers
  • Play a key role in the management of product recalls and mock product recall exercises
  • Oversee the management, processing, tracking and close-out of Product Complaints
  • Oversee the management, processing, tracking and close-out of Product Quality Reviews
  • Propose and manage an annual budget to cover all Quality Department activities
  • Liaise with members of the Global Quality organisation as necessary to provide input into above-country Quality strategies and activities
  • Ensure that accurate records are maintained, as required by company policies and external regulatory requirements
  • Approximately 10% travel, including to Ireland and Switzerland

Experience and Education

  • Degree in a Life Science, Chemistry or Pharmacy
  • Substantial experience as a Responsible Person for GDP
  • Substantial pharmaceutical industry experience in Quality roles with evidence of significant career progression to date
  • Experience of Quality across multiple product types eg solid oral tablets, biologics, plasma-derived therapies etc…
  • Experience working with electronic quality, document management and learning management systems
  • Direct line management experience
  • Substantial experience conducting / managing supplier and pre-wholesaler audits
  • In the absence of line management experience, substantial experience of coaching and mentoring

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 realise 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, Company Car Benefit (dependent on role) Contributory Pension Scheme, Private Health Cover and Life Assurance.

Empowering Our People to Shine

Learn more at takedajobs.com

Locations

L-Shire - United Kingdom - Paddington

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time

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