Third Party Quality Lead

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.

As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

As a Third Party Quality Lead at ICON will play a key role in ensuring that contracted services and associated batch documentation meet applicable GMP, regulatory, client quality, and quality agreement requirements. This role also provides the opportunity to apply third-party quality management expertise in a cross-functional R&D

Responsibilities include some of the following:

• Act as the primary day-to-day quality contact for assigned third parties and projects, working with internal stakeholders involved in activities contracted to those third parties.
• Monitor and support management of third-party quality performance and compliance with applicable GSK standards, quality requirements, current Good Manufacturing Practice (cGMP), regulatory requirements, and quality agreements.
• Coordinate and support quality governance meetings with assigned third parties, including preparation of quality performance information, documentation of actions, and follow-up to closure.
• Draft, coordinate, review, maintain, and support approval of quality agreements and related quality documentation, as applicable.
• Review and assess third-party quality management system records, including deviations, complaints, change controls, corrective and preventive actions (CAPAs), investigations, and validation-related documentation, and ensure timely follow-up in accordance with cGMP and quality agreements
• Identify, assess, document, communicate, mitigate, and escalate quality issues and risks through the appropriate GSK quality governance pathways.
• Review and approve, or provide quality recommendations on, documentation required to support batch disposition/release activities within the scope of the engagement and applicable authorization.
• Ensure documentation associated with assigned third parties is appropriately reviewed, managed, retained, and archived in accordance with applicable requirements.
• Support third-party selection, qualification, approval and maintenance of approval status, as appropriate to the assigned scope.
• Participate in third-party audit planning, preparation , execution, response follow-up, and CAPA oversight, as applicable.
• Provide quality support for product or process transfers between GSK and third parties and for other assigned external manufacturing activities

Your Profile:

• Bachelor’s degree in pharmacy, Science, Engineering, or related discipline, or an equivalent level of knowledge, understanding, and hands-on GMP experience in the pharmaceutical environment.
• At least 5 years of pharmaceutical manufacturing and or quality experience.
• Practical knowledge of cGMP principles and regulatory expectations applicable to pharmaceutical development and manufacturing.
• Experience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation.
• Experience supporting or leading quality system activities such as deviations, investigations, complaints, change controls, CAPAs, inspections, audits, and root-cause analysis.
• Experience working with external manufacturing organizations, suppliers, service providers, or other third parties.
• Ability to make sound risk- based quality decisions and escalate issues appropriately.
• Proficient working knowledge of Microsoft Office applications, including Word, Excel, PowerPoint, Outlook, and Teams.

If you have the following characteristics, it would be a plus:

• Experience providing quality oversight for contract manufacturing organizations supporting API, cell banking, drug substance, drug product, or investigational medicinal products.
• Knowledge of the pharmaceutical R&D lifecycle, including clinical development manufacturing and technology transfer.
• Experience with batch documentation review and disposition/release support.
• Experience with quality agreements, third-party quality governance, quality performance monitoring, and supplier qualification.
• Ability to work independently, manage competing priorities, and consistently deliver agreed outputs in a matrixed and deadline-driven environment.
• Excellent written and verbal communication skills, with the ability to build effective working relationships and influence internal and external stakeholders.
• Strong attention to detail, analytical thinking, problem identification, and problem -solving skills.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply