Head – Quality Assurance (QA) | AGM / DGM

Bioplus Life Sciences Pvt. Ltd.; Bengaluru; On-site; INR 3,000,000 - 5,000,000; Full time

Job summary

Bioplus Life Sciences Pvt. Ltd. Bengaluru seeks a Senior QA leader to head Quality Assurance for pharmaceutical formulations and OSd, driving cGMP compliance, QMS robustness, and regulatory readiness.

Lead and mentor the QA team, manage regulatory inspections (US FDA, MHRA, TGA, ANVISA, EU GMP), oversee deviations, CAPA, change controls, and data integrity across QA, QC and manufacturing. A background of 20+ years in pharma QA with success in audits at major health authorities and familiarity

Qualifications

• 20+ years in Pharmaceutical Quality Assurance.
• Strong leadership of site QA and QMS.
• Experience handling major international regulatory inspections.
• Experience with nutraceuticals is a plus.
• Led at least 3 regulatory audits in last 3 years (USFDA/MHRA/EDQM/TGA/ANVISA).

Responsibilities

• Lead the QA function for pharmaceutical formulations and OSD.
• Establish and maintain robust QMS compliant with GMP and regs.
• Provide strategic leadership to the QA team on site.
• Coordinate regulatory inspections and customer audits.
• Ensure CAPA, investigations, deviations, OOS/OOT management.
• Oversee data integrity and ALCOA+ across QA, QC, manufacturing.
• Review quality documents, protocols, and reports.
• Drive inspection readiness and GMP awareness.
• Interface with Regulatory Affairs, Manufacturing, R&D, and senior management.
• Mentor and develop QA team members and succession plans.

Skills

QA leadership

GMP compliance

Regulatory inspections

QMS implementation

ALCOA+

Data integrity

CAPA & deviation

Documentation

Change control

Audits management

Education

M. Pharm.

Tools

LIMS

EDMS

Job description

Lead the site Quality Assurance function for pharmaceutical formulations and Oral Solid Dosage (OSD), driving cGMP compliance, quality systems, regulatory readiness, inspection management, and continuous quality improvement.

The candidate will be responsible for leading the site's Quality Assurance function, ensuring compliance with cGMP, regulatory requirements, quality systems, and international regulatory expectations. The role requires significant experience in handling regulatory inspections and audits from major international health authorities. Experience with Nutraceuticals will be an added advantage.

Key Responsibilities

• Lead the overall Quality Assurance function for the pharmaceutical formulation/OSD facility.
• Establish, implement, and maintain robust Quality Management Systems (QMS) in compliance with applicable GMP and regulatory requirements.
• Provide strategic and operational leadership to the QA team at the site.
• Ensure compliance with US FDA, MHRA, TGA, ANVISA, EU GMP and other applicable regulatory requirements.
• Lead preparation, coordination, and management of regulatory inspections and customer audits.
• Ensure timely investigation, response, CAPA implementation, and closure of audit/inspection observations.
• Oversee deviations, OOS/OOT, CAPA, change controls, complaints, product quality reviews, risk assessments, and investigations.
• Ensure effective implementation and continuous improvement of the site's QMS.
• Review and approve quality-related documents, procedures, protocols, reports, specifications, validation documents, and other controlled documents as applicable.
• Provide QA oversight for manufacturing, packaging, validation, technology transfer, qualification, and other GMP activities.
• Ensure appropriate batch release and compliance with approved specifications and regulatory requirements.
• Drive quality culture and GMP awareness across the organization, maintain continuous inspection readiness, and track changes in applicable regulations/guidelines.
• Interface with Regulatory Affairs, R&D, Manufacturing, QC, Engineering, Supply Chain, and senior management on quality and compliance matters.
• Lead and mentor the QA team, including succession planning and capability development.
• Identify quality risks and drive continuous improvement and compliance excellence across the site.
• Be responsible for data integrity across QA, QC, manufacturing, and computerized systems, with experience in ALCOA+ principles and electronic records/audit trails.

Qualifications & Experience

• M. Pharm.
• 20+ years of relevant experience in Pharmaceutical Quality Assurance.
• Strong experience in pharmaceutical formulations, particularly Oral Solid Dosage (OSD).
• Experience in leading site Quality Assurance functions and robust Quality Management Systems.
• Significant experience handling regulatory inspections and audits from major international health authorities.
• Experience with Nutraceuticals will be an added advantage.
• The candidate must have handled at least 3 regulatory audits from USFDA/MHRA/EDQM/TGA/ANVISA within the last 3 years. At least 1 audit must have been conducted within the last 1 year.
• Quality Assurance & QMS leadership.
• US FDA / MHRA / EU GMP / TGA / ANVISA compliance.
• Deviation, OOS/OOT, CAPA and change-control management.
• Root-cause analysis and problem solving.
• Quality metrics, management review and continuous improvement.
• Team leadership and people development.
• Excellent communication and documentation skills.

Employment Type Full-Time, Permanent

Experience 20+ years

Department Quality Assurance