Back to Job SearchROLE OVERVIEW
We are currently looking for a Senior Process Quality Excellence Specialist to join a leading pharmaceutical organization based in the UK. This is an exciting opportunity for a professional with a strong background in clinical quality and audits to support global clinical study operations within a dynamic, collaborative environment.
In this role, you will play a key part in strengthening the quality framework that underpins clinical study activities across the organization. Reporting to the Head of Process Quality Excellence, you will manage audit and inspection activities, ensuring readiness and compliance within the GCSO functions while fostering strong relationships across various internal teams and external stakeholders.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Senior Process Quality Excellence Specialist will be varied however the key duties and responsibilities are as follows:
• Lead and drive GCSO Inspection Readiness activities across all functions, collaborating closely with inspection teams to ensure preparedness.
• Participate in audit and inspection planning initiatives in conjunction with Global Quality teams.
• Act as the primary host for GCSO internal audits and support audit response activities.
• Represent GCSO during audits and inspections, including on-site preparation, and support the resolution of findings through CAPA processes.
• As the Senior Process Quality Excellence Specialist, you will support GCSO staff with audit and inspection responses and oversee CAPA tracking and resolution to ensure timely closure.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Senior Process Quality Excellence Specialist we are looking to identify the following on your profile and past history:
• A Degree or higher level in life sciences, quality, clinical research, or a related field.
• Proven experience totaling at least eight years in pharmaceutical quality assurance, clinical quality management, or clinical operations, with hands-on experience supporting or leading GCP audits and inspections.
• Extensive knowledge of GCP, ICH guidelines, and relevant international and local regulations for clinical studies.
• Strong experience in writing and revising SOPs, along with excellent planning, investigative, and root-cause analysis skills.
• Excellent communication skills in English, capable of explaining complex topics and working effectively across cultures and seniority levels.
WHAT’S IN IT FOR YOU?
Joining our client offers the opportunity to be part of a global organization committed to clinical excellence and quality innovation. You will work within a highly collaborative team, supporting critical audit and inspection processes that impact patient safety and clinical success. This role will also offer exposure to international regulations, with future opportunities as the organization transitions its office to a new location.
Key Words: Clinical / Quality Assurance / GCP / Audits / Inspections / CAPA / Regulations / Global Clinical Operations / SOPs / Inspection Readiness
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
