# Third Party Quality Lead

**Company**: ICON Strategic Solutions
**Location**: Blue Bell
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Blue-Bell-ICON/Third-Party-Quality-Lead_JR162105?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_80c75e72-6ca

## 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.

## Skills

### Required
- cGMP
- quality management
- regulatory compliance
- Microsoft Office

### Nice to have
- contract manufacturing
- pharmaceutical R&D
- batch documentation review
- quality agreements

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Source: [Apply at icon.wd3.myworkdayjobs.com](https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/US-Blue-Bell-ICON/Third-Party-Quality-Lead_JR162105?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)