Quality Systems Specialist

Walker Cole International is supporting a leading biotech organisation in the appointment of a Quality Systems Specialist at their modern manufacturing site in Scotland. This is an excellent opportunity to join a dynamic and fast-growing business working at the forefront of scientific innovation.

Key Responsibilities:

• Lead the implementation and improvement of site-wide Quality Risk Management (QRM) processes in alignment with ICH Q9.

• Maintain a central risk register and oversee risk reporting and mitigation planning.

• Facilitate cross-functional risk assessments using tools such as FMEA, FMECA, and statistical methods.

• Support audits and inspections by presenting quality risk and compliance strategies.

Candidate Profile:

• Experience within a GMP-regulated manufacturing environment, preferably in biotech or pharmaceuticals.

• Strong understanding of Quality Risk Management principles and regulatory expectations.

• Excellent communication and stakeholder engagement skills, with experience supporting audits.

• A degree or equivalent in a relevant scientific discipline such as Biology, Chemistry, or Pharmacy.

GMP / Quality / Risk / QRM / ICH Q9 / Quality Systems / Biotech / Pharmaceutical / FMEA / FMECA / Audit / Compliance / MHRA / Quality Management / Risk Assessment / Scotland / Quality Assurance / Life Sciences / QMS / Regulatory / Manufacturing