As the Senior Manager of Clinical Quality Assurance, you will lead the charge in establishing and maintaining a robust quality system that aligns with global regulatory standards and industry best practices. You'll collaborate with cross-functional teams, from Clinical Operations to Translational Medicine, to drive excellence across all aspects of our operations. From developing and implementing QA systems to overseeing audit programs, your work will play a vital role in bringing novel therapies to patients.
Responsibilities:
- Develop and implement quality systems compliant with ICH Guideline E6 (R2) GCPs, 21 CFR part 58 GLPs, and global regulatory requirements.
- Lead the design and execution of QA GLP/GCLP/GCP systems, risk management processes, and SOPs.
- Provide oversight for QA review and approval of study protocols, reports, publications, and regulatory submissions.
- Collaborate on investigations, risk assessments, corrective actions, and other QA processes.
- Establish and manage an early-stage clinical site quality audit program, ensuring compliance at all times.
- Drive nonclinical and clinical vendor, and internal quality audit programs.
- Work collaboratively to design and execute audit plans, ensuring adherence to regulations and standards.
- Develop training materials and conduct training sessions.
- Present clinical and nonclinical QA metrics to senior leadership.
Qualifications:
- Bachelor's or Master's degree in biology, chemistry, life sciences, or a related field.
- A minimum of 8+ years' experience in pharmaceutical/biotech/clinical research with significant GLP/GCLP/GCP exposure.
- Direct QA experience in GLP/GCLP/GCP within the pharmaceutical sector is essential.
- Previous involvement with nonclinical studies and CRO oversight.
- Strong multitasking abilities within a fast-paced environment.
- A self-motivated and detail-oriented approach with a "can-do" attitude.
- Excellent written and verbal communication skills with an emphasis on clarity.
- Proficiency in MS Office software (Word, Excel, PowerPoint, Project).
- Flexibility for approximately 20% travel, both domestically and internationally.
