George Higginson is currently searching for an experienced Senior Quality Specialist. You MUST have experience with GCP (Good Clinical Practice) across Ph. III. He is partnering with an up-and-coming clinical-stage Biotech, developing a ground-breaking nanobody for Inflammatory Diseases.
In this pivotal role, you will support senior management in ensuring Quality is at the heart of all company initiatives and act as advisor to the Clinical Development teams on all quality related GCP activities.
Main Responsibilities:
- To play a key role in defining, maintaining and monitoring the GxP Quality Management System (QMS)
- To ensure that the QMS meets all necessary regulatory requirements, including good-practice guidelines and standards, with specific 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.
- To perform GCP audits if required (for example audits to be conducted at short notice).
- 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:
- Minimum 5+ years in a similar role.
- Scientific degree (ideally pharmaceutical science, Biology, chemistry or related).
- GCP experience in Ph. III interventional studies is a requirement.
- 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
- Strong communication, negotiation and influencing skills.
- Strong conflict resolution abilities.
- 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.
- Highly organised self-motivator, able to prioritise activities, work well under pressure and meet deadlines.
- Ability to find pragmatic solutions for quality issues in a highly agile biotech environment.
How To Apply:
AL Solutions is a niche Life Science recruitment consultancy. We place professionals across the UK, Europe, the United States and Canada for a variety of Biotechnology, Pharmaceutical and CRO companies ranging from small start-ups to large global organisations. If you’re interested, please apply below. If this position doesn’t interest you, please visit our website for a list of more vacancies.
George Higginson
AL Solutions
george@alsolutions.co.uk
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Last updated on Apr 30, 2024