Description
As a Third Party Quality Lead at ICON, you will play a key role in ensuring that contracted services and associated batch documentation meet applicable GMP, regulatory, client quality, and quality agreement requirements.
Responsibilities include:
- Acting as the primary day-to-day quality contact for assigned third parties and projects
- Monitoring and supporting management of third-party quality performance and compliance with applicable GSK standards, quality requirements, current Good Manufacturing Practice (cGMP), regulatory requirements, and quality agreements
- Coordinating and supporting quality governance meetings with assigned third parties
- Drafting, coordinating, reviewing, maintaining, and supporting approval of quality agreements and related quality documentation
- Reviewing and assessing third-party quality management system records
- Identifying, assessing, documenting, communicating, mitigating, and escalating quality issues and risks
- Reviewing and approving documentation required to support batch disposition/release activities
- Ensuring documentation associated with assigned third parties is appropriately reviewed, managed, retained, and archived
- Supporting third-party selection, qualification, approval, and maintenance of approval status
- Participating in third-party audit planning, preparation, execution, response follow-up, and CAPA oversight
- Providing quality support for product or process transfers between GSK and third parties
Your Profile:
- Bachelor's degree in pharmacy, science, engineering, or related discipline
- At least 5 years of pharmaceutical manufacturing and/or quality experience
- Practical knowledge of cGMP principles and regulatory expectations
- Experience reviewing or approving GMP manufacturing, laboratory, batch, validation, and/or quality system documentation
- Experience supporting or leading quality system activities
- Experience working with external manufacturing organisations, 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
If you have the following characteristics, it would be a plus:
- Experience providing quality oversight for contract manufacturing organisations
- Knowledge of the pharmaceutical R&D lifecycle
- Experience with batch documentation review and disposition/release support
- Experience with quality agreements, third-party quality governance, and supplier qualification
- Ability to work independently and manage competing priorities
- Excellent written and verbal communication skills
- Strong attention to detail, analytical thinking, and problem-solving skills
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.