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. **Apply on the website**%
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.
Provide quality leadership and support to operational teams,
including the review of batch records, technical reports and clinical
trial protocols
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 **APPLY ON THE WEBSITE**
/
THE RFT GROUP, BioPharmaceutical Division specialise exclusively in
the recruitment of scientists, engineers and executives for the
biotechnology, pharmaceutical and medical device sectors.
Follow us on: , ,
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. **Apply on the website**%
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.
Provide quality leadership and support to operational teams,
including the review of batch records, technical reports and clinical
trial protocols
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 **APPLY ON THE WEBSITE**
/
THE RFT GROUP, BioPharmaceutical Division specialise exclusively in
the recruitment of scientists, engineers and executives for the
biotechnology, pharmaceutical and medical device sectors.
Follow us on: , ,
We need : English (Good)
Type: Permanent
Payment:
Category: Others
