Director, Clinical QA
The Director, Clinical QA, will lead and oversee the company’s clinical, pharmacovigilance/drug safety, and GLP QA functions. This includes overseeing the QA audit program and audits performed of the company’s records and GCP processes, reporting on deviations, recommending process improvements, and reviewing multiple other departments’ plans to facilitate the conduct of clinical studies in accordance with GCPs and reviewing pharmacovigilance/drug safety operations. The individual in this position will work closely with other QA disciplines (GMP, Computer Systems Validation and Inspection Management), and members of Clinical Development, Biostatistics and Data Management, Pharmacovigilance/Drug Safety, and Regulatory departments. The position reports to the Executive Director, Corporate Quality.
- Interaction with Pharmacovigilance/Drug Safety, Clinical and Computer Systems QA and other compliance personnel at partner companies and vendors.
- Provide QA guidance and policy recommendations for the company.
- Ensure appropriate updating of and compliance with internal QA SOPs associated with clinical development and pharmacovigilance/drug safety.
- Work with Inspection Management and Regulatory Affairs to host regulatory inspections related to the conduct of clinical studies and computer systems used by Affymax.
- Work with Regulatory Affairs and Inspections Management on regulatory agency interactions.
- Maintain awareness, and communicate changing compliance requirements; provide training and intelligence to the organization.
- Oversee and direct staff of internal and consulting auditors.
- Develop and manage clinical site and clinical vendor audit plans.
- Perform clinical site audits to evaluate GCP compliance; write and review reports; ensure follow-up of observations and corrective actions.
- Work with clinical sites to prepare them for FDA and other regulatory agency inspections as needed.
- Review clinical study reports, abstracts, posters, and other clinical documents for quality.
- Bachelors or Masters or advanced degree in a scientific discipline, with a minimum of 10 years of increasingly responsible experience in QA in the pharmaceutical industry.
- Broad knowledge of worldwide compliance requirements related to Clinical Development, pharmacovigilance/drug safety, and GLP.
- Experience with pharmaceutical development and commercial processes worldwide.
- Demonstrated leadership success in management, including developing and /or leading a compliance team.
- Excellent verbal and written communication skills.
- Analytical and interpretative skills enabling review and synthesis of reports another documents used in support of regulatory approval of Affymax products.
- Travel required.
Affymax, Inc. - 24 months ago