Director GCP, Quality & Compliance
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- DOE
- Start date
- 17 Sep 2020
- Closing date
- 1 Oct 2020
View more
- Discipline
- Quality, GCP, Regulatory Affairs, Compliance
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Director/Executive
Job Details
Director of Clinical Compliance
On behalf of my client I am recruiting for a Director of Clinical Compliance.
The successful candidate will support and work with the organization’s clinical study management teams and teammates across R&D Quality and Compliance. You will be a part of an expert team supporting global clinical development programs, with a special emphasis on pediatric trials, based in Dublin, Ireland.
Responsibilities:
• Active member of the R&D Quality and Compliance Clinical management team.
• Lead Clinical Compliance activities and compliance staff in one or more therapeutic areas. Handle multiple projects and ensure overall and timely completion of tasks.
• Works closely with compliance staff and clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
• Support deviation identification, reporting, and CAPA development and responsible for ensuring the development of audit strategy plan(s) and ensuring timely execution of plans for programs.
• Oversees GCP routine and complex audits including but not limited to investigator sites, internal processes, and vendors, and represent Regulatory Compliance in Working Groups as appropriate.
• Leads intra/inter-departmental teams and/or projects supporting continuous improvement of the Quality Management System. Builds positive support and acts as role model for change.
• May lead/support management of regulatory inspection activities such as readiness preparation, inspection management, and/or response management.
Qualifications:
• BA/BS and 12+ years of relevant experience OR 10+ years of relevant experience with an MS.
• Must have significant GCP audit and compliance experience. Clinical Quality Assurance/Compliance experience required. Bio-pharma sponsor or CRO experience required.
• Significant experience with pediatric clinical trials strongly preferred.
• Recognized as an expert resource on a range of clinical compliance topics.
• Strong verbal and written communication skills and interpersonal skills, and excellent organization skills and project management.
• Proficient in Microsoft Office suite. Experience with audit management/CAPA management programs strongly preferred.
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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