Are you an experienced professional in clinical research quality assurance looking to elevate your career? Maxis Clinical Sciences is offering an exciting full-time opportunity for a Senior Manager or Manager in Clinical Quality Assurance Compliance & Training at its Mumbai location. This role is ideal for individuals with over 5 years of experience in the pharmaceutical, biotech, or CRO industry, particularly in quality functions related to clinical trials.
📍 Job Overview
Job Title: Clinical Quality Assurance Compliance & Training
Location: Mumbai, India
Type: Full-Time
Experience Level: Senior Manager / Manager
Department: Clinical Research
🎯 Purpose of the Role
This position is designed to provide end-to-end quality oversight of clinical trial activities. The selected candidate will be responsible for ensuring inspection and audit readiness, maintaining compliance with global and local regulations, and safeguarding the integrity of clinical data and participant safety.
The role involves working closely with multiple teams, including Medical Science, Clinical Operations, Clinical Trial Supply Management (CTSM), and Clinical Data Management. The goal is to establish robust procedures and training programs that uphold the highest standards of Good Clinical Practice (GCP) and regulatory compliance.
🔍 Key Responsibilities
Develop and implement a risk-based quality compliance framework for clinical research activities.
Oversee training programs for team members, ensuring SOP-specific training is aligned with job roles.
Prepare and review Standard Operating Procedures (SOPs) for quality functions and support SOP development across clinical and data management teams.
Conduct quality reviews of key clinical documents, including protocols, synopses, clinical study reports (CSRs), and appendices.
Ensure compliance in operational activities such as site feasibility, site selection, monitoring reports, ethics committee documentation, and site close-out procedures.
Maintain audit readiness and support inspections by regulatory bodies, including DCGI and the US FDA.
🧠 Required Skills & Qualifications
Minimum 5 years of experience in a CRO, pharmaceutical, or biotech organisation within a quality assurance role.
Strong understanding of GCP guidelines, ICMR standards, and Drugs and Cosmetics Act regulations.
Proven experience in handling audits and inspections by regulatory authorities.
Exceptional attention to detail and conflict management skills.
Ability to work effectively in matrix business environments.
Demonstrated success through performance ratings, professional achievements, or industry recognition.
Application Link: https://www.linkedin.com/jobs/view/4297725409/?refId=yr%2FRH6eHQKO%2FjFOD64Ejfg%3D%3D&trackingId=yr%2FRH6eHQKO%2FjFOD64Ejfg%3D%3D
🌟 Why Join Maxis Clinical Sciences?
Maxis Clinical Sciences is known for its commitment to clinical excellence, regulatory integrity, and patient safety. Joining the team means being part of a forward-thinking organisation that values innovation, compliance, and continuous learning.
What You’ll Gain:
A leadership role in shaping clinical quality standards
Exposure to global regulatory frameworks
Opportunities for professional development and cross-functional collaboration
A dynamic work environment focused on ethical research and data integrity
📢 Final Thoughts
This is a unique opportunity for seasoned professionals to contribute to the quality backbone of clinical research. If you’re passionate about compliance, training, and ensuring ethical standards in clinical trials, this role at Maxis Clinical Sciences could be your next big move.