The experience you need to bring:

• Advanced degree in life sciences or scientific discipline
• 5 – 8 years total QA GCP experience (Pharma or Biotech or Medical Devices)
• Regulatory inspection readiness experience (working in a team but not the lead)
• Direct hands-on experience of working on audit planning, execution and delivery (at least 4 years)

Soft Skills you need to possess and practise:

• Ability to identify issues and offer solutions to problems in a pragmatic way
• Good attention to detail, with the ability to see the ‘big picture’
• Highly professional and self-motivated, experience working from home
• Ability to assimilate and analyse information rapidly
• Confidence to work alone or in a team
• Able to communicate easily with Operations team members as well as quality team members
• Articulate issues and situations succinctly
• Assertive

The successful candidate will be responsible for:

Auditing

• Coordinate and conduct internal system audits and external investigative site/vendor audits
• Create, maintain, and revise organisations Standard Operating Procedures, forms, and templates
• Evaluates responses to audit reports and performs follow-up with respondents, management, or others, if needed, to ensure resolution

QA Systems

• Coordinate, conduct, track, and resolve Corrective Action / Preventative Action (CAPA) completions
• Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records)
• Performs study sign-off including but not limited to QA statement preparation (internal/external) and report finalization
• Help in developing training materials and applicable tests and guides
• Creating content such as blogs and case studies and whitepapers per instructions from the Director of Operations

 

Inspection Readiness

• Participate and prepare for GCP inspections at client locations and investigator sites, under supervision

Quality Consulting

• Work alongside experienced quality consultants to understand the issues and problems of clients that need solutions
• Prepare and deliver assigned tasks per Project Manager/Project Director guidance and instructions.

For further information please contact Paul Shaw at Impel Talent at 07549 024401 or e-mail paul.shaw@impeltalent.com

Posted On: Wednesday, September 17, 2025