|Job title :||Head of QA - GxP|
|Location :||West Sussex|
|Job type :||Permanent|
|Salary :||£90000 - £100000 per annum + benefits|
|Contact name :||John Spring|
|Contact number :||+44 (0) 207 255 6650|
|Contact email :||email@example.com|
This is a rare role looking for a Senior Management level GCP QA professional to join a well-established CRO with 40 years in the pharmaceuticals industry across therapy areas such as oncology. The position is looking for someone to manage an international team and play a key part in the company's growth strategy.
Salary & Benefits:
Up to £100k + benefits
Role and responsibilities:
*Partner internally and globally with external stakeholders, managing world-class the GCP Quality Assurance program to enhance the company's growth.
*Manage the QA team with members in the UK and the US.
*Manage global GXP Quality Assurance processes, implementing QA initiatives/audit programs, including IT QA projects and continuous improvement.
*Oversee the CAPA process to ensure timely implementation of CAPAs, and escalation, where necessary.
*Conduct GXP audits of company systems, CRAs, clinical sites, external vendors and GMP audits as needed and ensures appropriate follow-up.
*Develop and leads audit /inspection readiness activities to ensure staff members are prepared for participation in regulatory inspections and audits.
*Assist in facilitating client audits and regulatory inspections.
*Manage quality system which provides guidance, tracking, and metrics of compliance.
Requires skills and qualifications:
*Minimum of a BA/BS in Scientific discipline required.
*Prior experience leading GCP Quality Assurance programs and interfacing with the FDA & EMA.
*International and oncology experience preferred.
*Management experience, at least 7 years in a CRO/pharmaceutical environment.
*Excellent knowledge and experience with GXP QA programs and regulatory requirements.
*Strong leadership and communications skills (verbal and written).
*Effective ability to anticipate challenges and to develop and implement solutions.
*Effective knowledge of MS Office computer skills.
*The ability and willingness to travel as required in the US and internationally.
This is a fantastic position for someone with cross-functional GxP QA experience looking for a new challenge with a fast-paced and growing organisation. The role will offer personal and career growth as well as a chance to play a key role in the oncology field of medicinal research.
To apply for this position and put yourself under immediate consideration, send your CV to firstname.lastname@example.org or call +44 (0) 207 255 6650