Third Party Quality Lead

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.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements

• A range of health insurance offerings to suit you and your family’s needs.

• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.

• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.

• Life assurance

• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site (https://careers.iconplc.com/benefits) to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here (https://careers.iconplc.com/reasonable-accommodations)

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here (https://wd3.myworkday.com/icon/d/task/1422$1235.htmld) to apply