Our client is an industry-leading biotechnology company that specializes in developing groundbreaking cancer therapies that harness the power of cutting-edge technologies. They are currently seeking a highly experienced professional to join their team as the Associate Director of Clinical (GCP) Quality.
Responsibilities:
- Proven track record in effectively managing and supervising CAPA plans, including writing, reviewing, approving, and closing them.
- Demonstrated capability in conducting and overseeing site, internal GCP, and vendor audits, along with directing and guiding audit follow-up actions.
- Proficiency in establishing Quality and Cross-Functional Standard Operating Procedures (SOPs) and processes, along with implementing associated document controls.
- Experience serving as a global document management system administrator.
- Skilled in managing and mentoring direct reports.
- Ability to coordinate cross-functional meetings between departments and Quality teams.
- Willingness to undertake other duties as assigned.
Qualifications:
- Bachelor's degree or higher qualification within life sciences
- At least 10 years' experience working in GCP Quality Assurance and/or GCP Compliance, additional GCP Auditing experience preferred
- In-depth knowledge of global regulations related to good clinical practice
- Excellent interpersonal communication skills along with proficiency communicating both verbally and written formats.
- Bilingual
- Willingness to travel
If you are interested, please apply with your CV attached.
