ORGANISATIONAL OVERVIEW
Lambda Therapeutic Research is a global full-service Clinical Research Organization headquartered in Ahmedabad, India. With facilities and operations strategically located in Mehsana (India), Las Vegas (USA), Toronto (Canada), Barcelona (Spain), London (UK), and Warsaw (Poland), we offer comprehensive end-to-end clinical research services to innovator, biotech, and generic pharmaceutical companies worldwide.
Our team of over 1500 professionals across the globe delivers full-spectrum clinical trial solutions powered by more than 20 years of service to the industry.
POSITION DETAILS
Role: Assistant General Manager – Late Phase QA
Company: Lambda Therapeutic Research
Department: Late Phase Quality Assurance
Location: Ahmedabad, Gujarat
Education: M.Pharm or Ph.D.
Experience: 15+ years in pharmaceutical quality assurance
CTC Range: 20 to 30 Lacs per annum
Employment Type: Full-time
ROLE OVERVIEW
The Assistant General Manager – Late Phase QA is a senior leadership role responsible for ensuring quality and compliance across late phase clinical trials. This position oversees audit activities, CAPA management, regulatory inspections, and quality systems for late phase functions.
You will lead quality initiatives, conduct system and study audits, support regulatory inspections, and ensure that all trial activities are conducted, recorded, and reported in compliance with applicable regulatory requirements, organizational policies, and client specifications.
This role requires deep expertise in ICH GCP, regulatory requirements, and quality systems, combined with strong leadership capabilities to guide teams and influence quality culture across the organization.
KEY RESPONSIBILITIES
Quality Governance and Oversight
Ensure data compilation for Quality Review Board Meetings for Late Phase trials and functions. Manage meeting preparation, facilitate discussions, prepare Minutes of Meeting, and follow up on action items to ensure closure.
Review effectiveness of CAPA management including identification, reporting, impact assessment, and implementation. Ensure corrective and preventive actions address root causes and prevent recurrence.
Review various study documents for compliance and quality. Issue QA statements and audit certificates as per applicable regulatory guidelines.
Audit Management
Determine whether all trial related activities were conducted, data recorded, analyzed, and reported accurately and in compliance with regulatory requirements, organizational policies, and client specifications.
Conduct routine audits at various stages for assigned projects, including in-process audits, on-site audits, and off-site audits.
Perform retrospective audits of study protocols and study related raw data as required.
Conduct and report system audits as per the system audit annual calendar. Ensure compliance with current ICH GCP, Lambda SOPs, Quality Systems, protocols, and applicable regulatory requirements.
Regulatory Inspection and Sponsor Audit Support
Support Head of QA and designees in handling regulatory inspections and sponsor system audits. Arrange data required for inspections and audits.
Coordinate responses to regulatory or sponsor queries pertaining to clinical trial and medical imaging issues. Participate in inspections and audits as required.
Process and Documentation Oversight
Participate in key internal project team meetings and facilitate quality discussions during these meetings.
Support preparation and review of QA SOPs. Review system SOPs of other departments including Clinical Trial Management, Medical Affairs, and Medical Imaging for correctness, adequacy, and compliance.
Provide audit and inspection support for assigned projects, advising project teams during preparation and conduct of audits and inspections.
Reporting and Communication
Update Head of QA and designees regularly on the level of compliance and compliance issues within late phase functions.
Communicate quality findings and recommendations to relevant stakeholders.
Ensure timely and accurate reporting of quality metrics and activities.
COMPETENCIES
Accountability
Take ownership of quality outcomes for late phase functions. Hold yourself and others accountable for compliance and continuous improvement.
Work Ethic
Demonstrate commitment to excellence in all quality activities. Maintain high standards of integrity and professionalism.
Initiative
Proactively identify quality risks and improvement opportunities. Take action before issues escalate.
Technical Knowledge
Maintain deep expertise in ICH GCP, regulatory requirements, quality systems, and audit methodologies. Stay current with evolving regulations and industry standards.
Organizational Culture Fit
Embrace and promote Lambda's values and quality culture. Contribute to a positive, collaborative work environment.
WHAT YOU WILL DO
Lead Quality Assurance for Late Phase
You will oversee all quality assurance activities for late phase clinical trials. This includes audit planning and execution, CAPA management, regulatory inspection support, and quality governance.
Conduct Audits
You will plan and conduct system audits, process audits, and study audits across late phase functions. You will assess compliance and identify areas for improvement.
Support Regulatory Inspections
You will support the organization during regulatory inspections and sponsor audits. You will ensure data is available, responses are prepared, and inspection readiness is maintained.
Review and Improve Quality Systems
You will review SOPs, study documents, and quality processes to ensure they meet regulatory requirements and organizational standards. You will drive continuous improvement in quality systems.
Mentor and Guide Teams
You will provide guidance to project teams on audit and inspection readiness. You will contribute to the development of quality culture across the organization.
Report to Leadership
You will keep senior leadership informed of compliance levels, quality issues, and improvement initiatives. You will provide regular updates on late phase quality activities.
WHAT YOU BRING
Education
M.Pharm or Ph.D. in a relevant discipline.
Experience
15+ years of experience in pharmaceutical quality assurance, with significant exposure to late phase clinical trials. Demonstrated experience in audit management, regulatory inspections, and quality systems.
Technical Knowledge
Deep understanding of ICH GCP, regulatory requirements for late phase trials, quality systems, and audit methodologies. Familiarity with clinical trial management, medical affairs, and medical imaging processes.
Leadership Skills
Ability to lead quality initiatives and influence across functions. Experience guiding teams and supporting regulatory inspections.
Communication
Strong written and verbal communication skills. Ability to prepare clear reports, present findings, and interact effectively with regulators, sponsors, and internal stakeholders.
WHY THIS ROLE MATTERS
Quality assurance in late phase clinical trials ensures that data collected during this critical stage is reliable, accurate, and compliant. Late phase studies often support regulatory submissions, label expansions, and post-marketing commitments. The quality of this data directly impacts patient safety and regulatory decisions.
As Assistant General Manager – Late Phase QA, you will lead the function that safeguards this data. Your work will ensure that Lambda continues to deliver trusted clinical research outcomes to global clients.
WHY LAMBDA THERAPEUTIC RESEARCH
Global Reach
Join a CRO with operations across India, USA, Canada, Spain, UK, and Poland. Your work will support clinical trials conducted worldwide.
Industry Leadership
Lambda has over 20 years of experience serving innovator, biotech, and generic pharmaceutical companies. You will work alongside industry veterans.
Senior Leadership Role
This is a key leadership position with significant responsibility and visibility. You will shape quality practices across late phase functions.
Career Development
Lambda offers opportunities for professional growth and advancement. Senior leaders are supported in their continued development.
Collaborative Environment
Work alongside experienced quality professionals, clinical operations teams, and project managers who share your commitment to excellence.
Purpose-Driven Work
Your leadership ensures that clinical trials are conducted with integrity and compliance, bringing safe and effective therapies to patients.
APPLICATION PROCESS
Submit your application through the Lambda Therapeutic Research careers portal.
The hiring team reviews all submissions.
Qualified candidates are contacted for an initial conversation.
Interviews are conducted with senior leadership and cross-functional partners.
Decisions and offers are communicated in a timely manner.
TO APPLY
Please submit your resume highlighting your quality assurance experience in late phase clinical trials. Include details of your audit management, regulatory inspection support, and quality systems expertise. Tell us why you are interested in this senior leadership role at Lambda Therapeutic Research.
Apply for the Assistant General Manager – Late Phase QA position at Lambda Therapeutic Research.
Lambda Therapeutic Research is an equal opportunity employer. We value diversity and are committed to creating an inclusive environment for all employees as we work together to deliver trusted clinical research outcomes globally.
