Pharma Quality Specialist Consultant at PA Knowledge Limited - Denmark

Melbourn, England, United Kingdom -

Full Time

Start Date

Immediate

Expiry Date

25 Aug, 26

Salary

0.0

Posted On

27 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

GxP Quality Management System, GMP Compliance, GDP Compliance, GCP Compliance, GLP Compliance, Computer System Validation, Data Integrity, Supplier Quality Auditing, CAPA Management, Regulatory Information Management, Product Lifecycle Management, Stakeholder Management, Process Mapping, Gap Assessment, Change Management, Qualified Person (QP) Certification

Industry

Business Consulting and Services

Description

Company Description 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. PA. Bringing Ingenuity to Life. Job Description Hybrid working - our approach is to be in the office or on client site a minimum of 2 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. 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. In this role, you will advise clients across pharmaceutical, biotechnology and related life sciences environments, supporting compliance with GMP, GDP, GCP and GLP requirements. You will lead and deliver quality transformation initiatives, combining strong hands‑on expertise with a pragmatic, client‑focused consulting approach. What you’ll do You’ll work across a diverse portfolio of client engagements, applying your quality expertise to deliver tangible impact. Your work will include: 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 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 by completing our online application 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. #LI-KP1 Additional Information 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]

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Responsibilities

Lead the design and implementation of GxP-compliant Quality Management Systems across pharmaceutical and biotechnology environments. Advise clients on regulatory compliance, computer system validation, and supplier quality while managing stakeholder relationships.