QMS Consultant – Regulated Industries
Location: United Kingdom Type: Full-Time Experience: 3+ Years
About Robosol
Robosol Software UK Limited is a long-established Microsoft Dynamics 365 Business Central partner with over 20 years of experience delivering ERP and quality solutions to regulated industries. We specialise in pharmaceutical, veterinary medicines, biotech, food and drink, FMCG, and wholesale distribution sectors, working with clients across the UK and internationally. Our team combines deep regulatory expertise with enterprise software capability, making us a trusted partner for organisations operating under MHRA, FDA, and EU GMP frameworks.
The Opportunity
We are looking for an experienced QMS Consultant to join our growing quality practice. This is a client-facing delivery role in which you will lead the implementation, validation, and operational support of Quality Management System platforms for our regulated industry clients. You will work as part of a multi-disciplinary team alongside our CSV and ERP consultants, bringing together compliance expertise and technical capability to deliver end-to-end quality solutions.
The ideal candidate is equally comfortable configuring a QMS platform as they are guiding a client QA team through day-to-day compliance workflows. You will bring a strong working knowledge of regulatory expectations under MHRA, FDA, and EU GMP, and be able to translate those requirements into practical, validated solutions.
Key Responsibilities
- Lead end-to-end implementation and configuration of QMS platforms for clients in pharmaceutical, veterinary, biotech, and food and drink manufacturing sectors.
- Validate QMS platforms in accordance with GAMP 5, EU GMP Annex 11, and FDA 21 CFR Part 11, producing all required validation deliverables including URS, FDD, IQ, OQ, PQ, RTM, and VSR.
- Support clients with quality operations across core QMS modules: Change Control, Deviations, CAPA, OOS/OOT Investigations, Complaints, Document Management, and Training Records.
- Develop and maintain client-facing QMS policies, SOPs, and validation documentation to a publication-ready standard.
- Collaborate with client QA, IT, and operational teams to ensure platform configuration meets regulatory requirements and business objectives.
- Conduct risk assessments and manage validation issues and deviations throughout the platform lifecycle.
- Provide structured training and guidance to client staff on QMS platform usage and GxP best practices.
- Work alongside Robosol’s CSV and ERP consultants to deliver integrated quality and compliance solutions, particularly where QMS interfaces with Business Central or other enterprise systems.
- Contribute to pre-sales activities including solution scoping, proposal writing, and client demonstrations where required.
What We’re Looking For
Essential
- Bachelor’s degree in Pharmacy, Life Sciences, Computer Science, or a related field.
- 3+ years of hands-on experience implementing or supporting a QMS platform (e.g. Veeva Vault QMS, MasterControl, ETQ, Pilgrim SmartSolve, or equivalent) in a regulated industry environment.
- Strong working knowledge of EU GMP Annex 11, GAMP 5, FDA 21 CFR Part 11, and ICH Q10.
- Proven ability to author and review validation deliverables: URS, FDD, IQ, OQ, PQ, RTM, and VSR.
- Solid understanding of core pharmaceutical quality processes: Change Control, CAPA, Deviations, Document Control, and Training Management.
- Excellent written and verbal communication skills, with the ability to engage credibly with both technical and quality stakeholders.
- Able to manage multiple concurrent client engagements with a high degree of autonomy.
- Meticulous attention to detail and a genuine commitment to quality and compliance.
Desirable
- Experience with QMS platforms that integrate with ERP systems, particularly Microsoft Dynamics 365 Business Central.
- Familiarity with data integrity principles (ALCOA+) and their application within electronic quality systems.
- Exposure to multi-site or international regulatory submissions and audits.
- Experience in a consulting or client-facing delivery environment.
Why Robosol
- Work on varied, high-impact engagements across pharmaceutical, biotech, and food and drink clients in the UK and internationally.
- Be part of a growing quality practice with a clear roadmap, including development of a proprietary QMS product.
- Collaborate with experienced ERP and CSV consultants within a supportive, specialist team.
- Genuine career progression opportunities as the practice scales.
- Competitive salary, benefits package, and flexible working arrangements.
Pay: From £50,000.00 per year
Benefits:
- Casual dress
- Company events
- On-site parking
Ability to commute/relocate:
- Basildon SS15 6TH: reliably commute or plan to relocate before starting work (required)
Experience:
- Quality management: 5 years (required)
Work Location: In person
