Pharma Quality Specialist Consultant (GxP QMS)

Location: Hybrid, based in the UK with office or client-site attendance at least 2–3 days per week; the role can be based in London Victoria or Melbourn, with up to 5 days per week on a client site.

Company

hirify.global is a global consulting firm combining strategy, innovation, technology, science, engineering, and design expertise to help clients transform regulated industries.

What you will do

• Lead the design, implementation, and transformation of GxP-compliant quality management systems across R&D, manufacturing, clinical, and distribution environments.
• Conduct process mapping and gap assessments, and develop quality policies, SOPs, standards, forms, and controlled documentation.
• Lead computer system validation activities, including validation strategies, protocols, test scripts, and data integrity controls.
• Support supplier qualification, audits, CAPA development, supplier improvement, and compliance risk mitigation.
• Lead RIM and PLM system implementations in collaboration with client IT, regulatory, quality, and business teams.
• Provide GxP regulatory expertise, inspection-readiness support, Qualified Person support, and client stakeholder leadership.

Requirements

• 8+ years of experience in pharmaceuticals, biotechnology, or life sciences, with a strong record in GxP QMS transformation and implementation.
• Scientific or technical background in life sciences, pharmaceutical sciences, quality, or a related discipline.
• Strong knowledge of GMP, GDP, GCP, GLP, FDA, EU GMP/EudraLex, MHRA, EMA, and ICH guidance.
• Hands-on experience with quality documentation, supplier qualification, audits, CAPA, compliance management, computer system validation, and data integrity.
• Experience with RIM and PLM system implementation is highly desirable; management consulting experience is also desirable.
• Applicants may need UK security clearance and must meet UK residency requirements, including British citizenship or 5 years of continuous UK residency.

Nice to have

• Qualified Person status.
• Experience with ISO 13485 and combination product environments.

Culture & Benefits

• Inclusive workplace focused on equality, diverse perspectives, and meaningful client work.
• Private healthcare and health and lifestyle benefits.
• 25 days of annual leave, plus a Christmas Eve half day and the option to buy 5 additional days.
• Company pension scheme, annual performance-based bonus, and PA share ownership.
• Tax-efficient benefits and opportunities to participate in community and charity initiatives.