Senior Director Clinical Quality Assurance
GxPeople is currently working with a global client who is seeking an Senior Director Clinical Quality Assurance to join their team in USA.
The Senior Director Clinical Quality Assurance is responsible for leading and supporting all areas ensuring compliance with GCP, ICH regulations and company policies and procedures. As a senior member the Director must also make sure that system audits are conducted and corrections are implemented, and compliance risks communicated. Additionally, this position is responsible for overseeing Pharmacovigilance, Biostatistics, Clinical Science, Clinical operations and Data management, as well as taking the lead on preparing, conducting and responding to regulatory agency audits of the Clinical sites and Quality management of CROs.
- Overseeing GLP and GCP activities in order to guarantee the safety of patients.
- Providing strategic direction reduce GCP and GLP quality and compliance issues.
- Ensuring the development of processes and procedures strategies required to maintain compliance by supporting the Clinical Quality Assurance Operations and systems functions.
- Writing reports following SOPs and regulations, as well as establishing an audit plan for the development of company programs.
- Providing strategic direction ensuring timely responses in order to maintain the company’s good positions with regulatory agencies and representing the company during regulatory inspections.
- Overall responsibility for the success and development of the CQA function.
Qualifications and Experience
- Bachelor’s Degree in pharmacy, biology or related scientific field and MSc in Regulatory affairs or related field.
- Extensive knowledge of FDA regulations and Computer System Validation, ICH guidelines and GXP regulations.
- Management experience, including planning and budget management at senior level (minimum 3 years).
- Experience in GCP Quality and pharmaceutical environment (minimum 10 years).
- In-depth understanding of the auditing process, the processes, techniques and phases of clinical development, of medical product’s impact.
- Excellent communication, organisational and project management skills.
- Up to 25% availability to travel.
For more information or, if you’d like to be considered for this position please call us on +44 20 3637 4393 or email email@example.com.