Assistant Manager - Quality Assurance

Immuneel Therapeutics Pvt. Ltd.; Bengaluru; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Immuneel Therapeutics Private Limited seeks a capable Assistant Manager - Quality Assurance to drive CSV activities and ensure cGMP compliance across the organization. The role interfaces with QA, IT, manufacturing, quality control and facilities to uphold data integrity and regulatory readiness.

The candidate will lead validation planning, risk assessments, and lifecycle activities for computerized systems, aligning with 21 CFR Part 11 and EU Annex 11 requirements.

Qualifications

• Bachelor’s or master’s degree in pharmacy, Life Sciences (Biotechnology, Molecular Biology, Microbiology, Biochemistry) and Engineering.
• 5–8 years of relevant experience in CSV / QA / computerized systems validation within regulated industries.
• Experience with GxP computerized systems and validation lifecycle principles.

Responsibilities

• Lead and/or support CSV activities for GxP computerized systems throughout their lifecycle.
• Review and approve validation deliverables (URS, risk assessments, validation plans, FS, test protocols, VMs, and reports).
• Ensure systems comply with GxP, 21 CFR Part 11, EU Annex 11, data integrity, and regulatory expectations.
• Perform validation risk assessments for new and existing systems.
• Coordinate with IT, QA, process owners, vendors and stakeholders for validation activities.
• Support audits/regulatory inspections with CSV documentation and evidence.
• Ensure validation activities follow SOPs and quality standards.
• Monitor project timelines, risks and deliverables.
• Participate in periodic reviews and retirement/decommissioning of systems.

Skills

Adaptable

Team player

Quality commitment

Organized

Persistent

Quick study

Judgment

Continuous learner

Education

Bachelor’s or Master’s degree in Pharmacy/Life Sciences/Engineering

Job description

Immuneel Therapeutics Private Limited is a pioneering start‑up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com

We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.

Working at Immuneel promises the excitement of an agile start‑up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work‑life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:

• Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.
• Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
• Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.
• Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.

Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting‑edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.

If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.

1. Role Title:

Assistant Manager - Quality Assurance

2. Department/Function:

Quality Assurance – AQA/DQA

3. Reporting Structure:

• Reports to: Senior Manager

4. Role Summary:

This individual is responsible for Computer System Validation activity across the Organization. He/She will interface with the internal QA, IT, manufacturing, quality control and facilities, to meet the QA requirements and compliant to cGMP requirements

5. Key Responsibilities:

• Implement DMS, LMS, QMS, eATR, eBMR and AMS
• Lead and/or support CSV activities for GxP computerized systems throughout their lifecycle.
• Review and approve validation deliverables, including URS, risk assessments, validation plans, functional specifications, test protocols, traceability matrices, and validation reports.
• Ensure systems comply with GxP, 21 CFR Part 11, EU Annex 11, data integrity, and applicable regulatory expectations.
• Perform validation impact assessments and risk assessments for new and existing computerized systems.
• Review system change controls, deviations, CAPAs, periodic reviews, and validation‑related documentation.
• Ensure appropriate data integrity controls are implemented and maintained.
• Coordinate with IT, QA, business process owners, vendors, and other stakeholders for validation activities.
• Support audits and regulatory inspections by providing CSV documentation and evidence.
• Ensure validation activities follow approved SOPs, policies, and quality standards.
• Monitor validation projects, timelines, risks, and deliverables.
• Participate in computerized system periodic reviews and retirement/decommissioning activities.

6. Primary Objectives:

• CSV compliance with the clinical and commercial batch releases.
• Participation in QMS related activities, Deviation, change control, OOS, investigation, risk assessment
• To access and support in the implementation and qualification of digital platforms for QMS, LMS, DMS, LIMS, and AMS
• Strong knowledge of GAMP 4, 5, 21 CFR Part 11, EU Annex 11, ALCOA+ principles, and data integrity.
• Experience with risk-based validation approaches and GxP computerized systems.
• Good understanding of SDLC and validation lifecycle methodologies.
• Experience in reviewing validation documentation and managing deviations, changes, and CAPAs.
• Strong communication, documentation, analytical, and stakeholder‑management skills.
• Experience with systems such as LMS, LIMS, QMS, DMS, AMS, and laboratory/computerized systems.
• Knowledge of cloud‑based GxP systems and SaaS validation.
• Experience supporting regulatory inspections and customer audits.
• Familiarity with electronic records/electronic signatures and data integrity assessments.
• Project management and team leadership experience.
• Good Clinical Practice (GCP) experience would be an added advantage.
• Soft Skills:

Interpersonal Skills

• Adaptable
• Team player
• Quality commitment
• Organized
• Persistent
• Quick Study
• Judgment
• Continuous learner

8. Qualifications:

• Bachelor’s or master’s degree in pharmacy, Life Sciences (Biotechnology, Molecular Biology, Microbiology, Biochemistry) and Engineering,
• 5–8 years of relevant experience in CSV / QA / computerized systems validation within the pharmaceutical, biotechnology, medical device, or other regulated industry.

9. Working Conditions:

• Role Type: Full Time and Onsite
• Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post‑Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday.
• Travel Requirements: No