Job Title: Manager/Sr. Manager - Quality Assurance
Competencies
Purpose of Job
Experienced Quality System Manager to lead the implementation, maintenance and continuous improvement of our electronic Quality Management System (eQMS). This role will oversee Quality System Compliance and Life-Cycle Management, ensuring alignment with global regulatory standards and best practices.
The ideal candidate will possess hands-on expertise in Veeva Vault or similar platforms and have a strong understanding of pharmaceutical quality systems, regulatory compliance, and product life-cycle management.
Skill Required
Roles and Responsibilites
· Quality System Compliance and Life-Cycle Management
· Lead the deployment and configuration of eQMS solutions and drive continuous improvement to enhance system efficiency and user experience.
· Maintain quality system compliance with US-FDA, EMEA and Other applicable regulations.
· Partner with External Stakeholders (MAH/PL/Partners) and Internal Stakeholders (Manufacturing, Quality Control, etc.) for day-to-day quality system operations.
· Develop and implement workflows of the quality system, like management of change controls, deviations, OOS/OOT, Complaints, and risk management, etc.
· Oversee system upgrades, changes to the workflows and validation activities throughout the system life cycle.
· Oversee the Monitoring and Reporting of Quality Metrics and support Quality Management Reviews.
· Provide training and support to end-users across the organization.
· Lead the all-time inspection readiness as an SME of Quality System Procedures and their compliance across the organization.
Qualification Required
Bachelor's / Master's degree in Pharmacy/Life Sciences field.
Relevant skills / Industry experience
Minimum 10+ years of experience in pharmaceutical quality systems management.
Proven expertise in Veeva Vault or similar platforms (MasterControl, TrackWise, etc.).
Strong knowledge of GxP, ICH Q10, FDA, and EMA regulations.
Good project management, communication, and stakeholder engagement skills.
Relevant professional / Educational background
Any other requirements (If any)
Preferred Attributes
Experience in global pharmaceutical or biotech organisations.
Ability to lead cross-functional teams and manage multiple priorities.
Compensation / Reward
Biotech, Ahmedabad, GJ, IN, 382213