Senior Quality Manager

7 days ago


Cambridge, Cambridgeshire, United Kingdom Pharma Partners Recruitment Ltd Full time

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.

nTo provide support and advice to Clinical Development teams with regards to:

nDefinition of appropriate compliant procedures within GxP functionsnManagement of quality issuesnTo ensure external contracted organisations supporting GxP activities are selected and responsibilities defined and documented.nTo monitor the performance of GxP service providers with regards to the relevant quality standards.nTo define and manage clinical audit programme and to preform GCP audits if required.nMaintain agreed quality metrics and dashboards to enable clear communication to senior management of compliance performance and any risks or issues identified.nTo 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.nProven track record in defining, implementing and maintaining Quality Management Systems for biotechnology or biopharmaceutical companies.nProven track record of monitoring and influencing the quality performance of internal functions and contracted service providers, including self-inspection and external audit experience.nComprehensive knowledge of GCP requirements as applied to biologics and related industry/regulatory guidelines governing clinical trials in the EU & USA.nBasic understanding of GLP and GMP requirements for biologicsnBasic Knowledge of GLP and cGMP and related industry/regulatory guidelines governing the manufacture of biologics in the UK, EU & US.nAbility to work in a flexible, collaborative style with colleagues and teams within the company and with external entities including CROs and consultants.


Experience:
nMinimum 5+ years in a similar role

Salary and benefits:
A highly competitive salary, stock options, annual bonus and wider benefits package is on offer.

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