Hybrid Senior Manager, Quality – Responsible Person (Import)

Posted last week

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About the role

  • 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)

Job type

Experience level

Senior

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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