Senior Quality Manager - GCP

Job Description
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.