Our client, a young science driven biopharmaceutical company with an early stage product development pipeline, have approval for a new role Quality Assurance Manager with responsibility for the oversight and maintenance of the Quality Management System (QMS) and Quality Assurance (QA) management within the company.
The successful candidate will represent QA within project teams providing input, strategies and options, ensuring a Quality culture is present throughout the organisation. As applicable, this hire will provide project teams and customers, quality guidance that is commensurate with the stage of development and be proactive for commercialisation.
Person fit: the ideal candidate will be a GCP Quality Leader who is self-driven and capable of working on their own initiative in a fast-paced dynamic environment. Proven track record in Quality Assurance; leading GCP audits and overseeing compliance with all GCP, GLP and GMP requirements. Travel approx. 15% depending on operational activities.
Responsibilities of Clinical QA Manager, GCP:
Maintain and develop the QMS in accordance with relevant regulatory requirements and business need
Implement an effective QA process, including internal and external audit programs, and ensure timely completion of audits
Lead the quality oversight process on outsourced activities, which includes;
- Developing and maintaining Technical Agreements with vendors in line with relevant regulatory and business requirements
- Performance of onsite audits as required – vendors / clinical sites
- Analysis and reporting of KPIs
- Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
Manage the Documentation Control process, ensuring that policies and procedures are up to date, and available to all relevant parties
Ensure that all activities are conducted in compliance with the requirements of GMP and GCP.
Contribute to Company Training procedures as required
Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company
Requirements for Clinical QA Manager, GCP
Bachelor’s or Masters Degree in a Scientific discipline or related field.
8+ years Quality Assurance experience in industry, of which 3+ years’ experience in pharma/biotech Clinical Quality Assurance (GCP).
Extensive knowledge of QA systems in GxP environments.
Proven auditing experience of GxP suppliers/vendors.
Proven knowledge of regulatory/compliance requirements, especially those applicable to GCP.
GMP experience is preferred.
Extensive experience developing and implementing Quality Agreements.
Knowledge of relevant regulatory requirements.
Excellent interpersonal, communication, and problem-solving skills.
Strong computer skills.
Flexible in reacting to changing priorities in a dynamic business environment.
Demonstrated coaching/mentoring skills.
Attractive salary and benefits offered, dependent on experience.
For further details, please contact Larry on 01-2302400 / firstname.lastname@example.org
The RFT Group, BioPharmaceutical Division specialise exclusively in the recruitment of scientists, engineers and executives for the biotechnology, pharmaceutical and medical device sectors. www.rftgroup.ie
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