Regulatory Compliance Specialist

2 weeks ago


Irvine, North Ayrshire, United Kingdom GSK Full time
Job Summary:
As a Compliance Governance Professional at GSK, you will play a critical role in ensuring the site adheres to cGMP, the GSK Quality Management System, and all relevant regulatory, licensing, and pharmacopeia requirements. This position is responsible for managing the QMS implementation process, ensuring all QMS documents are assessed for applicability and deployment. Additionally, you will act as a QMS Champion across all site operations, providing support, training, and coaching to site personnel, as well as partnering with the Central Group as needed.

Key Responsibilities:
• Manage the QMS implementation process, ensuring all QMS documents are assessed for applicability and deployment.
• Act as a QMS Champion across all site operations, providing support, training, and coaching to site personnel, as well as partnering with the Central Group as needed.
• Manage the site management monitoring audit program, ensuring delivery of cGMP compliance, QMS "in place" and "in use" expectations to deliver inspection readiness.
• Support site pest control program and all Level 3 / 4 inspections.
• Carry out verification of audit CAPA, as required to ensure these are "in place," "in use," and effective.
• Manage the QRI process at site, ensuring the site responds to relevant QRI, and communicate to Quality Council.
• Own and manage the site change control process for all quality impacting changes, ensuring all targets are met, performance tracked, and communicated as required.
• Drive and improve the compliance culture to ensure audit readiness via coaching, mentoring, and training.

Required Qualifications & Skills:
• Degree in a relevant science subject or suitable extensive experience in an appropriate discipline within a pharmaceutical environment.
• Experience in interpreting regulatory expectations and QMS.
• Experience in resolving cGMP / compliance issues.

Preferred Qualifications & Skills:
• Auditing experience.
• High attention to detail.
• Good influencing, communication, and coaching skills.


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