Pharma Quality Specialist Consultant

We are seeking an experienced Pharma Quality Specialist Consultant to join our Life Sciences consulting team, specialising in GxP Quality Management System (QMS) design, transformation and implementation.

Responsibilities

QMS design and process transformation

• 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.
• Supporting Product Lifecycle Management (PLM) system implementations to enable end to end control of product data.
• 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

• Management Consultancy experience highly desirable.
• 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 highly desirable but not essential.
• Experience with ISO 13485 and combination product environments would be advantageous but is not required.

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 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 at