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Pharma Quality Specialist Consultant

PA Consulting, City of Westminster

Pharma Quality Specialist Consultant

Salary not available. View on company website.

PA Consulting, City of Westminster

  • Full time
  • Permanent
  • Onsite working

Posted today, 16 Sep | Get your application in now to be one of the first to apply.

Closing date: Closing date not specified

Job ref: 91a39ab243284960b3203d8456d00f8b

Location ref: City of Westminster

Full Job Description

  • Leading the design and implementation of GxP-compliant QMS across R&D, manufacturing, clinical and distribution environments.
  • Conducting process mapping and gap assessments, and supporting the rollout of new or enhanced systems aligned to global regulatory standards (including GMP, GDP, GCP, GLP, FDA 21 CFR 210/211, EU GMP/EudraLex, ICH Q7/Q10).
  • Authoring, reviewing and maintaining quality policies, standards, SOPs, forms and controlled documentation, enabling sustainable compliance and operational excellence.
  • Supporting effective change management, embedding best practices through close collaboration with quality, technical and business teams.
    • Computer system validation and data integrity
  • Leading and advising on computer system validation (CSV) activities within GxP environments.
  • Supporting the development of validation strategies, protocols, test scripts and data integrity controls in line with global regulatory expectations.
    • 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.

    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., 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.

    We believe in the power of ingenuity to build a positive human future. As strategies, technologies, and innovation collide, we create opportunity from complexity. Our teams of interdisciplinary experts combine innovative thinking and breakthrough technologies to progress further, faster. Our clients adapt and transform, and together we achieve enduring results. We are over 4,000 strategists, innovators, designers, consultants, digital experts, scientists, engineers, and technologists. And we have deep expertise in consumer and manufacturing, defence and security, energy and utilities, financial services, government and public services, health and life sciences, and transport. Our teams operate globally from offices across the UK, Ireland, US, Nordics, and Netherlands.,
  • Hybrid working - our approach is to be in the office or on client site a minimum of 2 or 3 days per week. However, the actual time you spend and where you spend it will vary by role or assignment, including up to 5 days per week on a client site.
  • This role can be based in our London Victoria or Melbourn offices
    • Our Life Sciences teams work with leading pharmaceutical, biotechnology and healthcare organisations to strengthen quality, compliance and operational excellence across the product lifecycle - from early research through to commercial supply., 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

  • 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)

Direct job link

https://www.jobs24.co.uk/job/pharma-quality-specialist-consultant-127403986
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