Pharma Quality Specialist Consultant

• Supplier quality and audit support

  • Applying hands‑on experience in supplier qualification, evaluation and audit activities (internal and external).
  • Interpreting audit findings and supporting CAPA development, supplier improvement initiatives and ongoing risk mitigation activities.

• Regulatory systems implementation

  • Leading the implementation and optimisation of Regulatory Information Management (RIM) systems to improve submission tracking, data integrity and global regulatory oversight.
  • Supporting Product Lifecycle Management (PLM) system implementations to enable end‑to‑end control of product data, changes and documentation across development phases.
  • Working closely with client IT, regulatory and quality teams to tailor solutions that are practical, scalable and compliant.

• Regulatory and Qualified Person (QP) support

  • Acting as a subject matter expert on GxP regulations and inspection readiness.
  • Acting as, or supporting, a Qualified Person (QP) for product certification and release, where appropriate.

• Client and stakeholder engagement

  • Building trusted relationships with clients, quality leaders, business stakeholders and regulators.
  • Translating complex regulatory expectations into clear, practical process improvements.
  • Leading and facilitating cross‑functional collaboration to deliver successful QMS and regulatory initiatives.

Qualifications

We’re looking for a quality professional with strong consulting instincts and the confidence to operate in complex, regulated environments. You’ll ideally bring:

• Management Consultancy experience highly desirable
• A scientific or technical background (life sciences, pharmaceutical sciences, quality or a related discipline).
• Typically 8+ years’ experience within pharmaceuticals, biotechnology or life sciences, with a strong track record in GxP QMS transformation and implementation.
• Extensive experience drafting and managing quality documentation, including SOPs, standards, policies, forms and templates.
• Strong knowledge of global GxP regulatory frameworks, including FDA, EU GMP/EudraLex, MHRA, EMA and ICH guidance.
• Hands‑on experience with supplier qualification, audits, CAPA and compliance management.
• Experience of RIM and PLM system implementation in regulated environments (highly desirable).
• Knowledge of computer system validation and data integrity principles.
• Excellent problem‑solving, communication and stakeholder management skills.
• QP status is highly desirable but not essential.
• Experience with ISO 13485 and combination product environments would be advantageous but is not required.

We know the skill-gap and ‘somewhat need to tick every box’ can get in the way of meeting brilliant candidates, so please don’t hesitate to apply – we’d love to hear from you.

Apply today

Please be aware that some of our UK roles at PA Consulting require a UK security clearance. All PA people are required to undergo background checks and to achieve the Baseline Personnel Security Standard however, some UK roles also require higher levels of National Security Vetting, where applicants must have at least 5 years of continuous residency in the UK. We therefore ask that you only apply if you meet the residency requirements (i.e. you are a British citizen or have been resident in the UK for the past 5 years), as this is the prerequisite for a security clearance. If you're unsure about your eligibility, we encourage you to review the UK Government’s guidance on security vetting before applying.

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Additional Information

Life At PA

Life At PA encompasses our peoples' experience at PA. It's about how we enrich peoples’ working lives by giving them access to unique people and growth opportunities and purpose led meaningful work. Our purpose guides how we work with our clients and our teams, and support our communities, to deliver insight and impact, solving the world’s most complex challenges. We're focused on building a workplace that values human difference and diverse mindsets, and a culture of inclusion and equality that unlocks the potential in our people so everyone can be their best self. Find out more about Life at PA here.

We are dedicated to supporting the physical, emotional, social and financial well-being of our people. Check out some of our extensive benefits:

• Health and lifestyle perks accompanying private healthcare
• 25 days annual leave (plus a bonus half day on Christmas Eve) with the opportunity to buy 5 additional days
• Generous company pension scheme
• Opportunity to get involved with community and charity-based initiatives
• Annual performance-based bonus
• PA share ownership
• Tax efficient benefits (cycle to work, give as you earn)

We’re committed to advancing equality. We recruit, retain, reward and develop our people based solely on their abilities and contributions and without reference to their age, background, disability, genetic information, parental or family status, religion or belief, race, ethnicity, nationality, sex, sexual orientation, gender identity (or expression), political belief, veteran status, or any other range of human difference brought about by identity and experience. We welcome applications from underrepresented groups.

Adjustments or accommodations - Should you need any adjustments or accommodations to the recruitment process, at either application or interview, please contact us on [email protected].