Job Description
Our client, a cutting edge scientifically driven Biotech company with strong development pipeline and multiple blockbuster products, now seeks a Director of GCP Quality who will lead direct interaction with regulatory inspectors and act as an inspection host during audits.
The successful candidate will direct and manage cross-functional teams in inspection readiness, ongoing inspections, and inspection follow-up for GCP/GPV/GLP inspections by global regulatory authorities.
This hire will perform inspection readiness visits at global clinical sites. Hence this role will require circa 30-40% travel. Additionally, this hire will work with functional leaders to build inspection readiness capabilities across the organization at non-manufacturing facilities.
The ideal candidate will be GCP Quality professional who is self-motivated, hard-working, achievement-oriented and the ability to work effectively in a dynamic environment.
Responsibilities of Director, GCP Quality Inspection Management:
Directs / manages inspections through the preparation, performance and follow-up of items requested by international regulatory agencies and partner audits.
Directs / manages inspection responses, commitments, post-inspection activities, corrective and preventative actions, resolving conflicts for timely closure.
Supports and leads teams implementing best practices and improvements to assure teams are inspection ready at all times.
Develops tools to improve inspection management process; determine system improvements.
Directs and manages cross-facility (other company sites) and cross-GxP inspection activities.
Develops and manages inspection metrics and reports trends.
Performs inspection readiness visits at clinical sites in support of potential regulatory agency inspections
Collaborates with cross-functional teams responding to incoming inquires during inspections and audits and ensure timely and accurate responses.
Provides advice and direction to company departments on quality and inspection related issues.
Requirements for Director, GCP Quality Inspection Management:
Bachelors Degree in relevant Scientific discipline.
10+ years Pharma / Biopharma industry experience, 5+ years of which regulatory inspection in GxP, GCP preferred
Proven experience in preparing and conducting regulatory authority inspections with GCP, GLP, and GPV preferred.
Direct interaction with inspectors preferred.
Knowledge and understanding of global GxP regulations with emphasis on GCP and ICH.
Knowledge of clinical development, pharmacovigilance, laboratory practices.
Demonstrated ability to interface with senior leaders and cross-functional teams.
Good problem solving, written and verbal communication skills.
Demonstrated ability to effectively manage multiple priorities with a sense of urgency.
Attention to detail and accuracy of work.
Please phone Larry on +353 1-2302400 / larry@rftgroup.ie
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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