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Senior Quality Manager
5 months ago
Working as a Senior Quality Expert/Manager - GCP, you will act as the advisor to the Clinical Development teams on all quality related GCP activities. This will be an exciting opportunity with a clinical-stage biopharmaceutical company with multiple Phase 3 assets.
Key Responsibilities:
- To play a key role in maintaining and monitoring the GxP QMS ensuring it meets all regulatory requirements and standards, with emphasis on GCP compliance.
- To provide support and advice to Clinical Development teams with regards to:
- Definition of appropriate compliant procedures within GxP functions
- Management of quality issues
- To ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.
- To monitor the performance of GxP service providers with regards to the relevant quality standards.
- To define and manage clinical audit programme and to preform GCP audits if required.
- Maintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.
- To maintain awareness of, and ensure compliance with, policies and procedures relating to quality standards within the Company.
Skills/Knowledge Competencies:
- Substantial experience of successfully managing quality issues in a biotechnology or biopharmaceutical environment.
- Proven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharmaceutical companies.
- Proven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including self-inspection and external audit experience.
- Comprehensive knowledge of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA.
- Basic understanding of GLP and GMP requirements for biologics
- Basic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US.
- Ability to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.
Experience:
- Minimum 5+ years in a similar role
Salary and benefits:
A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.
