|Job title :||Senior QA Manager|
|Location :||Dublin, Republic of Ireland|
|Job type :||Permanent|
|Salary :||€90000 - €95000 per annum|
|Contact name :||John Spring|
|Contact number :||+44 (0) 207 255 6650|
|Contact email :||email@example.com|
This role is with a leading biopharmaceutical company who are looking for a Clinical Quality (GCP) Senior Manger that is capable of supporting their clinical development programs.
They primarily need someone with strong Good Clinical Practice (GCP) knowledge, audit skills, communication (with internal and external stakeholders) and the ability to manage multiple simultaneous projects.
You will be a part of an expert team supporting global clinical development programs, with a special emphasis on pediatric trials, although prior experience in this is not a mandatory requirement.
Act as Clinical Compliance Lead for assigned clinical trials in multiple therapeutic areas, handling projects to ensure timely completion of tasks.
Lead the development of the audit strategy plans.
Provision of training and oversight of contract auditors.
Manage GCP routine and complex audits which include investigator sites, internal processes, and vendors amongst others.
Work in close collaboration with clinical study management teams to provide expert clinical compliance information, managing and escalating (where appropriate) issues and supporting initiatives relating to continuous improvement.
Support of all deviation identification, reporting and CAPA development
Assistance in readiness preparation, directly supporting regulatory agency inspection. Assist in coordination of response to any findings.
Evaluation, writing and reviewal of SOPs and performing other activities in support of an integrated cross-functional quality management system (QMS).
Degree level education, ideally in a relevant scientific field
Must have at significant number of years GCP audit and compliance experience. Bio-pharma sponsor or CRO experience.
Significant experience with pediatric clinical trials strongly preferred, but not mandatory.
Strong verbal and written communication skills and interpersonal skills.
Experience with audit management/CAPA management programs strongly preferred.
Excellent organization skills and project management.
Ability to travel approximately 25% required (within Europe)
This is a great role for a Manager/Senior Manager looking to grow their career within GCP Quality. Excellent salary and benefits on offer, within a growing team doing ground breaking work in multiple life-saving therapies to positively impact millions of lives in the future.
Interested? Get in touch - firstname.lastname@example.org // +44 (0) 207 255 6650