Associate Director – Operational Quality – Cell&Gene sites

I’m representing a leading biotech as they seek an Associate Director of Quality in London. This is a permanent role with great growth prospects, as my client expands their existing portfolio and develops an incredible pipeline of Cell&Gene therapies.

Reporting to the VP of International Quality, the scope of the role is to support the activation of commercial sites and will help the build-out of the operational support activities for treatment center selection, activation, and quality operational oversight. Additionally, this role will establish the quality risk management plans for each site, and work closely with the technical Apheresis team and the QA audit team on qualifying sites. The position is hybrid in London and from home but will require up to 25% travel to sites in the EU and internationally.

This role works closely with the cross-functional teams within QA to will help build the QMS that supports site selection, activation, and monitoring. The person will work on providing compliance expertise that supports investigations and CAPA management and investigation of product complaints.

This individual will support Cell and Gene programs in late phase and commercialization. They must demonstrate success in operational excellence, and engage teams and stakeholders for collaboration in advancing quality outcomes.

Core Responsibilities:

• Build out the quality risk management plans and identify mitigation plans
• Execute the risk management plan to support clinical activities
• Communicate effectively with senior leaders project plans, compliance risks, and mitigations
• Work closely with the Audit and Inspection quality function on-site qualifications and establish the audit strategy for Auditing and Performance oversight
• Establish and maintain Quality Agreements
• Work with the business areas on site selection
• Support site inspections- work closely with the cross-business functions and the QA inspection functions to prepare for inspections to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions
• Responsible for real-time inspection readiness
• Site Training and QMS development- support the development of site training by working closely with the Apheresis team
• Identify and evaluate the maturity of the QMS at the sites and support the remediation of gaps in procedures.

Essential Requirements:

• Relevant degree in a scientific or health field
• Experience working with biologics and advanced gene therapy regulations
• GCP and PV experience in Cell& Gene arena and working with clinical sites
• Background working with CDMOs and management of a manufacturing site.
• GMP knowledge of CDMO requirements working with Authorised Treatment Centres.

This role provides hybrid working and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI’s, healthcare, and a car allowance.

If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar on +441273 952176, or apply with your CV.

I’m representing a leading biotech as they seek an Associate Director of Quality in London. This is a permanent role with great growth prospects, as my client expands their existing portfolio and develops an incredible pipeline of Cell&Gene therapies.

Reporting to the VP of International Quality, the scope of the role is to support the activation of commercial sites and will help the build-out of the operational support activities for treatment center selection, activation, and quality operational oversight. Additionally, this role will establish the quality risk management plans for each site, and work closely with the technical Apheresis team and the QA audit team on qualifying sites. The position is hybrid in London and from home but will require up to 25% travel to sites in the EU and internationally.

This role works closely with the cross-functional teams within QA to will help build the QMS that supports site selection, activation, and monitoring. The person will work on providing compliance expertise that supports investigations and CAPA management and investigation of product complaints.

This individual will support Cell and Gene programs in late phase and commercialization. They must demonstrate success in operational excellence, and engage teams and stakeholders for collaboration in advancing quality outcomes.

Core Responsibilities:

• Build out the quality risk management plans and identify mitigation plans
• Execute the risk management plan to support clinical activities
• Communicate effectively with senior leaders project plans, compliance risks, and mitigations
• Work closely with the Audit and Inspection quality function on-site qualifications and establish the audit strategy for Auditing and Performance oversight
• Establish and maintain Quality Agreements
• Work with the business areas on site selection
• Support site inspections- work closely with the cross-business functions and the QA inspection functions to prepare for inspections to respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions
• Responsible for real-time inspection readiness
• Site Training and QMS development- support the development of site training by working closely with the Apheresis team
• Identify and evaluate the maturity of the QMS at the sites and support the remediation of gaps in procedures.

Essential Requirements:

• Relevant degree in a scientific or health field
• Experience working with biologics and advanced gene therapy regulations
• GCP and PV experience in Cell& Gene arena and working with clinical sites
• Background working with CDMOs and management of a manufacturing site.
• GMP knowledge of CDMO requirements working with Authorised Treatment Centres.

This role provides hybrid working and a strong culture with the support and opportunities to progress further into your career. Alongside this, my client also offers a comprehensive benefits package, including a generous bonus scheme, LTI’s, healthcare, and a car allowance.

If you have the skills required and would like to discuss the full details of the job, please contact Katie Dunbar on +441273 952176, or apply with your CV.