At a Glance
- Tasks: Lead quality assurance for Apheresis operations and support international expansion of Cell & Gene programmes.
- Company: Join a pioneering company in the Cell & Gene therapy sector, making a real impact on healthcare.
- Benefits: Enjoy flexible working options, competitive salary, and opportunities for professional growth.
- Other info: Open to candidates from the UK, Western Europe, or the US; mentorship opportunities available.
- Why this job: Be part of a dynamic team driving innovation in healthcare with a focus on quality and compliance.
- Qualifications: 6+ years in Cell & Gene sector; Master's degree preferred; experience in quality roles essential.
The predicted salary is between 48000 - 84000 £ per year.
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Senior Manager/Associate Director, QA Apheresis, London
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Client:
Location:
London, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
5e643222b417
Job Views:
7
Posted:
25.08.2025
Expiry Date:
09.10.2025
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Job Description:
Role Summary
The Associate Director, QA Apheresis will support the Apheresis Operations Team onboarding and
monitoring of clinical and commercial treatment centers and defining the strategy for the
international expansion of Cell & Genetic programs. The role will establish the quality risk
management plans, work closely with cross-functional Apheresis Operations, QA, CMC, Supply Chain
and Commercial teams to ensure QA oversight is maintained.
Key activities include developing, lead and direct the establishment of capabilities for Operational
quality managing Cell procurement, and Infusion activities at Apheresis and Infusion centers across
Cell & Gene programs.
The role will closely partner with operational stakeholders to lead/support the development and
execution of quality projects, quality & technical risk management including execution of associated
mitigation plans, and to participate in Cell & Genetic therapies projects and governance committees.
This role will help build the international QA compliance Apheresis expertise that supports Clinical and
Commercial C&G Programs.
We are open to candidates based in the UK, Western Europe or US for this role. We can also consider candidates at either AD or Senior Manager level.
Key Responsibilities
• Support Apheresis Operations with onboarding of commercial centers (reviewing, drafting,
approving Quality Agreements, audits (if required)
• Establishment of strategic roadmap for quality oversight of internationally for innovative
therapeutic programs.
• Support/Establish ATC (Apheresis Treatment Centers) Performance Management Reviews
across relevant region to gain insights regarding efficiency and operational performance
across the GXP operations, including identification of opportunities for improvement and
associated actions.
• Serve as a QA trusted advisor/ partner with business stakeholders.
• Establishment and maintenance of UK Human Tissue Licensing Expertise and US 1271 CFR to
ensure compliance requirements are met. Compliance to Good Tissue Practice legislation.
• For late phase programs, support initial launch and expansion requirements.
• Represent Quality in Cell & Genetic Programs for the International Expansion, participate/lead
teams to meet and deliver business & financial priorities and goals.
• Support/lead risk management activities, including mitigation plans and associated execution.
• Provide quality leadership and management for the monitoring of the regulatory and external
intelligence for best practices, emerging trends and projection of future capabilities
requirements to support Cell & Genetic Therapies programs.
• Support/Partner with operational stakeholders for international/EU vendor selection,
qualification and oversight.
• Work closely with the Audit and Inspection Quality Function to establish the audit strategy for
Auditing and Performance oversight and support technical Treatment Centers audits.
• Work closely with the cross- functional partners to prepare for and support US/ EU/ UK Health
Authority inspections, respond to information requests, adjudicate compliance discussions,
and negotiate any required corrective actions. In addition, work on providing compliance
expertise that supports investigations and CAPA management.
• Create and foster a culture of collaboration, development, and engagement for advancing
quality outcomes and operational excellence.
• Lead and mentor other team members, support development of organizational capabilities
and talent building.
• Act as the Human Tissue Authority Designated Individual (DI) and responsible for the HTA
Persons Designated (PDs). Management responsibilities of a team in UK/EU and/or US.
• Be available for on-call QA support for Apheresis Operations team for resolution of quality
events.
Demonstrated skills and competencies
E – Essential
P – Preferred
Experience
• 6+ years of experience in Cell and Gene sector, or the equivalent combination of education
and experience in a regulated pharmaceutical environment (E)
• At least 3 years’ experience in a Quality related role; ideally in a Pharmaceutical or Medical
Device environment (P).
• Experience in Veeva Platform (P)
• Experience with regulatory inspections, particularly with the Human Tissue Authority
regulator (P).
Qualifications
• Master\'s degree or relevant comparable background & certifications (P).
Skills/Specialist knowledge
• Ability to interact with senior leadership in establishing strategic plans, communicating status
of key initiatives, including making recommendations and/or attempt to influence decisions
in the best interest of the company. (E)
• In-depth EU/US ATMPs health regulatory agency knowledge, human tissue establishment
licensing and experience across GXP life cycle in Cell & Gene therapy and/or Biologics (E).
• Broad technical knowledge Tissue licensing and Tissue regulations in the EU and US (E).
• Current knowledge of industry trends and best practices in Cell/Gene therapies. Medical
device knowledge a plus.
• Proven expertise / experience with strategies for gene- and cell therapy products, preparation
and inspections. (P)
• Demonstrated strategic planning and execution skills required for operational effectiveness
and compliance. (E)
• Operational Excellence experience with proven ability to lead improvement projects-
Experience with Root Cause Analysis, data analytics, and other Operational Excellence
experience, such as LEAN, DMAIC, Six Sigma. (P)
• Excellent communication skills and a proven track record Influencing/building/promoting a
culture of Quality and Excellence. (E)
• Ability to apply risk management principles to decision making and operational priorities (E).
• Critical thinking and problem-solving skills (E)
• Apheresis or Good Tissue Practice Quality Experience (P)
Senior Manager/Associate Director, QA Apheresis in London employer: Autolus Limited
As a leading player in the Cell & Gene therapy sector, our company offers an exceptional work environment in London, where innovation meets collaboration. We prioritise employee growth through mentorship and development opportunities, fostering a culture of excellence and engagement. With a commitment to quality and compliance, we provide our team with the resources and support needed to thrive in their careers while making a meaningful impact on global health.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Manager/Associate Director, QA Apheresis in London
✨Tip Number 1
Network with professionals in the Cell and Gene therapy sector. Attend industry conferences or webinars where you can meet potential colleagues and learn about the latest trends. This will not only enhance your knowledge but also increase your visibility to hiring managers.
✨Tip Number 2
Familiarise yourself with the Veeva Platform, as experience with this system is preferred for the role. Consider taking online courses or tutorials that focus on Veeva to demonstrate your commitment and readiness for the position.
✨Tip Number 3
Stay updated on regulatory changes related to Human Tissue Authority and Good Tissue Practice legislation. Subscribe to relevant newsletters or join forums where these topics are discussed to show your proactive approach to compliance.
✨Tip Number 4
Prepare to discuss your experience with risk management and operational excellence during interviews. Think of specific examples where you've successfully led improvement projects or applied critical thinking to solve complex problems in a regulated environment.
We think you need these skills to ace Senior Manager/Associate Director, QA Apheresis in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in the Cell and Gene sector, particularly in quality roles. Emphasise your leadership skills and any specific projects that align with the responsibilities of the Senior Manager/Associate Director position.
Craft a Compelling Cover Letter:Your cover letter should clearly express your motivation for applying to this role. Discuss how your background aligns with the key responsibilities outlined in the job description, such as your experience with regulatory inspections and quality management.
Highlight Relevant Skills:In your application, focus on essential skills such as strategic planning, risk management, and operational excellence. Provide examples of how you've successfully applied these skills in previous roles, especially in regulated environments.
Showcase Your Knowledge:Demonstrate your understanding of industry trends and best practices in Cell and Gene therapies. Mention any specific knowledge you have regarding EU/US ATMPs health regulations and how it relates to the role you're applying for.
How to prepare for a job interview at Autolus Limited
✨Know Your Quality Standards
Familiarise yourself with the latest regulations and quality standards in the Cell & Gene therapy sector. Be prepared to discuss how you have implemented these standards in previous roles, especially in relation to Apheresis operations.
✨Demonstrate Cross-Functional Collaboration
Highlight your experience working with various teams such as QA, CMC, and Supply Chain. Share specific examples of how you have successfully collaborated on projects to enhance operational quality and compliance.
✨Showcase Your Leadership Skills
As a Senior Manager or Associate Director, you'll need to lead and mentor others. Prepare to discuss your leadership style and provide examples of how you've developed team capabilities and fostered a culture of quality.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving and critical thinking skills. Think of scenarios where you had to apply risk management principles or lead improvement projects, and be ready to explain your thought process and outcomes.
