GM/DGM - QA

Getwell Pharmaceuticals; Rewari; On-site; INR 8,000,000 - 12,000,000; Full time

Job summary

Getwell Pharmaceuticals seeks a senior QA leader with 20+ years of experience in sterile pharmaceutical QA to oversee site-wide QA operations for sterile injectables. The role emphasizes regulatory readiness, data integrity, and robust quality systems.

The ideal candidate will have hands-on expertise in aseptic processing, Annex 1 implementation, CCS, and governance of audits including USFDA, EMA, MHRA, and other global regulators.

Qualifications

• 20+ years of experience in QA within sterile pharmaceutical manufacturing.
• 8+ years in a senior leadership role overseeing site-wide QA for sterile injectables.
• Experience with sterile oncology products for regulated markets.
• Experience with global regulatory inspections and audits (USFDA, EMA, MHRA, ANVISA, WHO-GMP, PIC/S).
• Expertise in sterility assurance, Annex 1 implementation, CCS, data integrity, and quality risk management.
• Experience in setting up and leading QA organizations for new or expanding sterile facilities.
• Strong leadership and communication capabilities.

Responsibilities

• Lead site-wide QA operations for sterile manufacturing.
• Ensure compliance with regulatory requirements and inspections.
• Develop and implement quality systems and sterility programs.
• Drive data integrity and risk management.
• Collaborate with global functions and audits readiness.

Skills

Leadership

Regulatory inspections

Quality systems

Aseptic operations

Data integrity

Stakeholder management

Education

Pharmacy degree

Job description

Role & responsibilities

• M.Pharm / B.Pharm / M.Sc. with 20+ years of rich experience in Quality Assurance within sterile pharmaceutical manufacturing.
• Minimum 8 years in a senior leadership role handling site-wide QA operations for sterile injectable facilities.
• Extensive experience in sterile oncology products catering to regulated markets.
• Demonstrated expertise in successfully handling and hosting global regulatory inspections and customer audits, including USFDA, EMA, MHRA, ANVISA, WHO-GMP, PIC/S, and other international agencies.
• Proven track record in establishing and maintaining robust quality systems, sterility assurance programs, and inspection readiness culture.
• Strong exposure to aseptic processing, Annex 1 implementation, Contamination Control Strategy (CCS), data integrity, and quality risk management.
• Experience in setting up and leading QA organizations for new or expanding sterile facilities will be preferred.
• Excellent leadership, stakeholder management, communication, and team-building capabilities.

Preferred candidate profile

• Regulatory Inspection Management & Audit Readiness
• Global GMP Compliance
• Sterility Assurance & Aseptic Operations
• Quality Systems Excellence
• Data Integrity & Quality Risk Management
• Leadership & Team Development
• Strategic Planning & Cross-functional Collaboration