QC & Training Manager

The QC & Training Manager will oversee end-to-end clinical trial activities from a quality perspective, ensuring compliance with applicable regulations and guidelines. The role will be responsible for establishing procedures and trainings to ensure protection of human subjects, data integrity, and quality compliance.

Requirements

• B Pharma
• M Pharma/PG Diploma in Clinical Research
• >5 years experience in a CRO/Pharma/Biotech organization in Quality department with experience of Quality activities in Clinical Research department
• Strong eye for detail and ability to spot inconsistencies a must and good conflict management skills
• Must have experience in handling audits & inspections of DCGI, US FDA
• Thorough knowledge of recent GCP guidelines, ICMR guidelines, Drugs and Cosmetic Act regulations and other applicable regulations pertaining to clinical trials
• Experience of working in matrix business environments preferred
• Strong track record of success as demonstrated through annual performance ratings and/or professional accomplishments and awards
• Quality oriented mindset and skill set
• Experience in auditing processes and procedures, including the development of plans for corrective and preventive action (CAPA)
• In-depth working knowledge of clinical trial regulations, good clinical practice (GCP) guidelines and other frameworks, and their implications for clinical research
• Proactive approach to reviewing, updating and improving processes based on current knowledge of the regulatory requirements
• Have strong analytical and problem-solving skills and the ability to present solutions
• Able to work under pressure and prioritize workload effectively, able to ensure timely completion of tasks to high quality in a matrix organization
• Eye for details, Sense of urgency & desire to excel
• Proficiency with Excel or other quality management systems/ tools
• Result oriented and performance driven
• Excellent interpersonal & communication skills to effectively interact with a broad range of audience

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship
• Four Day Work Week
• Generous Parental Leave
• Tuition Reimbursement
• Relocation Assistance