Job Description
Our client, a cutting edge scientifically driven Biotech company with commercial product and strong development pipeline, now seeks an experienced Associate Director Clinical Quality and Compliance (GCP) to support all therapeutic areas and clinical development programs.
This successful candidate will act as Subject Matter Expert regarding Clinical Quality and Compliance (GCP), performing global risk assessment for investigator site and vendor audit planning. This hire will lead cross-functional teams, including global clinical study management teams advising on areas of GCP risk and mitigation of such, promoting a culture of quality.
This hire will exercise strong project management and communication skills, and strategic thinking ability ensuring the company meets regulatory, scientific, and business objectives in a matrixed organization.
The ideal candidate will have advanced qualifications and operating in similar leadership GCP Clinical Quality role within Pharma / Biopharma industry.
Key Responsibilities:
- Serve as Clinical Quality Business Partner lead for assigned clinical trial programs. Handle multiple projects and ensure overall and timely completion of tasks.
- Collaborate with the Audit, Inspection and CAPA Management Team within R&D Quality & Medical Governance.
- Works closely with clinical study management teams to provide expert clinical compliance information, manage identified issues, and support continuous improvement.
- Leads/Assists in readiness preparation, and/or directly support regulatory agency inspection. Leads/Assist in coordination of response to any findings.
- Lead deviation identification, reporting, and CAPA development.
- Leads intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
- Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
Person Spec:
- Bachelors’ Degree in Science of related discipline and 10+ years of relevant experience . Alternatively, MSc with 8+ years of relevant experience.
- 6+ years of audit and compliance experience. Must have significant GCP audit and compliance experience. Bio-pharma sponsor experience preferred.
- Knowledge and understanding of global GxP regulations with emphasis on GCP and ICH.
- Recognized as an expert resource on a range of clinical compliance topics.
- Experience with audit management/CAPA management programs strongly preferred.
- Excellent organization skills and project management.
- Strong verbal and written communication skills and interpersonal skills.
- Proficient in Microsoft Office suite.
- Ability to travel approximately 10% required.
For further details 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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