Pharma Quality Specialist Consultant

• 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 handson expertise with a pragmatic clientfocused consulting approach.

What youll do

Youll 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 GxPcompliant 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 handson 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 endtoend 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 crossfunctional collaboration to deliver successful QMS and regulatory initiatives.

Qualifications :

Were looking for a quality professional with strong consulting instincts and the confidence to operate in complex regulated environments. Youll 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.
• Handson 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 problemsolving 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 dont hesitate to apply wed 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 youre unsure about your eligibility we encourage you to review the UK Governments guidance on security vetting before applying.

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Additional Information :

Life At PA encompasses our peoples experience at PA. Its 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 worlds most complex challenges. Were 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) 

Were 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  

Remote Work :

No

Employment Type :

Full-time