Quality Assurance Manager
7 days ago
We are seeking a highly skilled Quality Assurance Manager to join our team at Pharma Partners Recruitment Ltd. As a Quality Assurance Manager, you will play a key role in maintaining and monitoring our Good Clinical Practice (GCP) Quality Management System (QMS) to ensure compliance with regulatory requirements and standards.
Key Responsibilities:
- To maintain and monitor the GCP QMS, ensuring it meets all regulatory requirements and standards.
- To provide support to our Clinical Development teams with regards to:
- Defining compliant procedures within GxP functions.
- Managing quality issues.
- To ensure external contracted organizations supporting GxP activities are selected and responsibilities defined and documented.
- To monitor the performance of GxP service providers with regards to relevant quality standards.
- To define and manage clinical audit programs and support in GCP audits if required.
- To 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.
Requirements:
- 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 2+ years in a similar role.
What We Offer:
A highly competitive salary, stock options, annual bonus, and wider benefits package is on offer. You will be required to work onsite in Cambridge 2 times a week.
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