Director, Clinical Quality Assurance & Compliance

Job Description

• Responsible for adherence with GCP quality system's procedures • Identify and assess regulatory and quality risks in activities • Accountable for Quality Assurance & Compliance duties for clinical development programs • Oversee development, implementation, maintenance, and performance of GCP Quality Assurance systems • Collaborate with clinical study management team and Quality team for expert clinical compliance information • Design, implement, monitor, and maintain the Quality Management System for GCP • Lead teams and projects aimed at enhancing the GCP Quality Management System • Author, review, and approve GCP records and documents • Assist in identifying and developing Corrective and Preventive Actions (CAPA) • Ensure qualification and oversight over auditors and external vendors • Develop audit strategy plans and ensure timely execution • Conduct routine and complex GCP audits • Provide compliance reporting to senior management and governance forums • Manage regulatory inspection activities • Support regulatory agency inspections and audits • Foster a culture of quality within the organization • Fulfill other assigned duties

Qualifications

• Proficiency in applying GCP standards • Extensive expertise in GCP regulations and quality systems • Experience in Clinical QA & Compliance and GCP audit processes • Track record of managing clinical trials • Self-driven, detail-oriented, and willing to accept temporary responsibilities • Authority in Clinical QA and Compliance field • Effective negotiation and collaboration skills • Willingness to innovate and adapt best practices • Strong project management and time management skills • Comfortable in a dynamic small company setting • Bachelor’s Degree with 12+ years' experience OR Master’s Degree with 10+ years' experience OR Ph.D. with 8+ years' experience in GCP/GMP environment • Proficient in investigations, CAPAs, change control records • Proficiency in overseeing and conducting audits

Benefits

• Collaborative environment • Opportunity to work at dynamic biotech company • Exciting career opportunity