Pharma Quality Specialist Consultant (Life Sciences)

Location: Hybrid, based in the London Victoria or Melbourn office, with a minimum of 2 days per week in the office or on a client site and potentially up to 5 days per week on a client site. Applicants for roles requiring UK security clearance must be British citizens or have at least 5 years of continuous UK residency.

Company

hirify.global is a global consulting firm combining strategy, innovation, science, engineering, technology, and design expertise across multiple industries, including health and life sciences.

What you will do

• Lead the design, transformation, and implementation 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 and support validation strategies, testing, and data integrity controls.
• Manage supplier qualification, audits, CAPA development, supplier improvement, and compliance risk mitigation.
• Implement and optimise Regulatory Information Management and Product Lifecycle Management systems with client IT, regulatory, and quality teams.
• Provide GxP regulatory expertise, inspection-readiness support, Qualified Person support, and cross-functional client leadership.

Requirements

• Typically 8+ years of experience in pharmaceutical, biotechnology, or life sciences environments.
• Scientific or technical background in life sciences, pharmaceutical sciences, quality, or a related discipline.
• Strong experience in GxP QMS transformation and implementation, quality documentation, supplier qualification, audits, CAPA, and compliance management.
• Knowledge of global GxP frameworks, including FDA requirements, EU GMP/EudraLex, MHRA, EMA, and ICH guidance.
• Experience with computer system validation, data integrity, and stakeholder management.
• UK security-clearance eligibility may require British citizenship or at least 5 years of continuous UK residency.

Nice to have

• Management consultancy experience.
• Experience implementing RIM and PLM systems in regulated environments.
• Qualified Person status.
• Experience with ISO 13485 and combination product environments.

Culture & Benefits

• Private healthcare and health and lifestyle benefits.
• 25 days of annual leave plus a bonus half day on Christmas Eve, with the option to buy 5 additional days.
• Generous company pension scheme and annual performance-based bonus.
• PA share ownership and tax-efficient benefits, including cycle-to-work and give-as-you-earn schemes.
• Opportunities to participate in community and charity initiatives within an inclusive workplace.

Hiring process

• Apply through the online application process.
• Background checks and Baseline Personnel Security Standard screening are required; some roles require additional UK national security vetting.