Manager CQA

Althera Laboratories India Pvt Ltd, Bangalore; Bommasandra; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Althera Laboratories India Pvt Ltd in Bengaluru seeks an experienced Manager/Senior Manager Corporate Quality Assurance to strengthen its corporate QA function and support quality governance across sites and external partners.

The role requires 13-18 years in pharma QA with strong EU GMP exposure, audit-facing experience, and proven leadership of QA teams. This position focuses on GMP compliance, QMS deployment, and collaboration with manufacturing sites and external partners.

Qualifications

• 13-18 years of pharmaceutical QA experience.
• Manager/Senior Manager level with demonstrated people-management experience.
• Strong European regulatory / EU GMP exposure.
• Hands-on European audit-facing experience is essential/preferred.

Responsibilities

• Lead Corporate QA activities and ensure GMP and QMS across sites.
• Manage European regulatory and EU GMP compliance requirements.
• Lead/support European regulatory, customer and GMP audits, including audit preparation, responses and CAPA closure.
• Drive QMS elements including Deviation, CAPA, Change Control, OOS/OOT, QRM, PQR/APQR and Supplier/CMO Quality Management.
• Provide corporate QA oversight and support quality governance across manufacturing sites.
• Lead, mentor and develop the QA team and effectively manage cross-functional stakeholders.

Skills

Leadership

People management

Regulatory knowledge

Audit experience

Quality Management

Job description

Position Overview

We are looking for an experienced and dynamic Manager / Senior Manager Corporate Quality Assurance to strengthen our Corporate QA function and support quality governance across manufacturing sites and external partners.

The ideal candidate should have 13-18 years of experience in the pharmaceutical industry, with strong exposure to European regulatory requirements, EU GMP, regulatory inspections/audits, Quality Management Systems and people management. Experience in handling or supporting European customer/regulatory audits and working in a corporate/CQA environment will be preferred.

Role & responsibilities

• Lead Corporate QA activities and ensure effective implementation of GMP and Quality Management Systems across sites.
• Manage European regulatory and EU GMP compliance requirements.
• Lead/support European regulatory, customer and GMP audits, including audit preparation, responses and CAPA closure.
• Drive QMS elements including Deviation, CAPA, Change Control, OOS/OOT, QRM, PQR/APQR and Supplier/CMO Quality Management.
• Provide corporate QA oversight and support quality governance across manufacturing sites.
• Lead, mentor and develop the QA team and effectively manage cross-functional stakeholders.

Preferred candidate profile

• 1318 years of pharmaceutical QA experience.
• Currently at Manager/Senior Manager level with demonstrated people-management experience.
• Strong European regulatory / EU GMP exposure.
• Hands-on European audit-facing experience is essential/preferred.
• Corporate QA (CQA) exposure preferred.
• Excellent communication, leadership, analytical and stakeholder-management skills.