Senior Manager of Quality ensuring compliance with Good Distribution Practices for medicinal products in the UK and Ireland. Leading the regional Quality team and maintaining regulatory oversight in collaboration with stakeholders.
Responsibilities
Ensure compliance with Good Distribution Practices (GDP) for the storage, transport, and distribution of medicinal products across the UK and Ireland
Lead the regional Quality team, maintain a robust Quality Management System (QMS), provide regulatory oversight
Partner with internal and external stakeholders to ensure product quality, compliance, and continuous improvement
Review and approve GDP-related procedures, records, and documentation
Support audits and inspections; ensure inspection readiness and regulatory commitments are met
Drive continuous improvement initiatives across Quality and/or Supply Chain
Assess and manage quality risks, escalating significant issues to senior management
Ensure staff training and qualification in line with current GDP requirements
Serve as Regional Process Owner for QMS and represent Quality on cross-functional teams to resolve regional quality issues
Requirements
Degree educated
Eligible to act as Responsible Person / Responsible Person (import) (RP/RPi) in the UK, meeting all MHRA eligibility criteria
Previous relevant experience performing RP duties under a Wholesale Dealer's (Human) Authorisation (WDA(H)), or equivalent quality/QA experience within a pharmaceutical organization
Strong knowledge of UK and EU regulatory frameworks, including: MHRA and EMA roles, GDP, UK Wholesale Distribution and Import regulations, and the EU Pharmaceutical Directive
Membership of a UK professional body is mandatory
Demonstrated ability to make timely, compliant, risk-based decisions with high attention to detail
Proven experience managing small teams and working collaboratively across functions and seniority levels
Excellent analytical, problem-solving, communication, and presentation skills
Proficient in Microsoft Office, ERP systems, quality management systems, and information and communication technologies.
Benefits
Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Job title
Senior Manager, Quality – Responsible Person (Import)
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