Quality and Continuous Improvement Lead

Astellas; Addlestone; Hybrid; GBP 50,000 - 90,000; Full time

Job summary

An innovative health partner is seeking a proactive leader to manage key business processes and drive strategic planning. This pivotal role involves overseeing vendor relationships, ensuring compliance, and enhancing operational excellence. With a hybrid working model, you will balance professional and personal life while contributing to impactful health solutions. Join a forward-thinking company dedicated to improving patient outcomes through a deep understanding of their needs. This is a unique opportunity to make a difference in the pharmaceutical industry, collaborating with senior leaders and driving initiatives that matter.

Qualifications

• Significant professional experience in the pharmaceutical industry.
• Strong understanding of Drug Safety functional areas.

Responsibilities

• Lead and manage key business and operational processes.
• Drive strategic planning and vendor relationships.
• Ensure compliance and inspection readiness.

Skills

Vendor Management

Strategic Planning

Budgeting

Operational Excellence

Drug Safety Knowledge

Quality Compliance

Project Management

Education

Bachelor's degree

Master's degree

Job description

At Astellas we are a progressive health partner, delivering value and outcomes where needed.

We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.

We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.

Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

The Opportunity:

In this role you will lead and manage key business and operational processes within the Functional Unit, ensuring systems and activities run efficiently, effectively, and in full compliance at all times. You will play a central role in driving strategic planning—partnering with senior leaders to shape and execute the annual objectives—while also maintaining oversight of vendor relationships and ensuring continuous inspection readiness. This is a high-impact position that requires a proactive, detail-oriented leader who can balance operational excellence with long-term strategic goals.

Hybrid Working:

At Astellas we recognize that our employees enjoy having balance between their professional and home lives. We are proud of our hybrid approach which empowers you to have flexibility on whether to work from home or in the office.

Key Activities for this role:

• Supporting the development and execution of a pragmatic outsourcing strategy aligned with portfolio needs, vendor performance, business risk, and Astellas’ strategic direction, while ensuring compliance with vendor oversight processes and identifying continuous improvement opportunities.
• Analyzing vendor budgets against actuals and identifying cost-saving efficiencies, while serving as a subject matter expert to address cross-functional questions related to resources, processes, systems, training, and quality.
• Coordinating outsourcing activities across the full lifecycle—from planning to steady-state operations—implementing key performance indicators (KPIs) to monitor vendor and study team performance and driving operational excellence across multiple functional areas.
• Leading inspection readiness efforts, including managing Corrective and Preventive Actions (CAPAs), Trial Master File (TMF) oversight, Learning Management System (LMS) coordination, and training compliance, while representing the Functional Unit in all quality and compliance initiatives and forums.
• Driving strategic planning, budgeting, and operational integration by collaborating with senior leaders on annual objectives, supporting technology deployment and system enhancements, and ensuring consistent communication and process governance across the Functional Unit.
• Significant professional experience, including a track record within the pharmaceutical industry.
• Strong understanding of responsibilities and processes within one or more Drug Safety (DS) functional areas.
• Proven experience in portfolio planning, forecasting, and budgeting.
• Solid background in quality, compliance, and/or inspection and audit readiness.
• Familiarity with project management (PM) methodologies preferred.

Education:

• Bachelor’s degree or equivalent required a Master’s degree or equivalent preferred.

Additional Information:

• This is a permanent, full-time position.
• This position is based in London, United Kingdom.
• This position follows our hybrid working model. The role requires a blend of home and approx. 1 day per quarter in our London office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.