Site Quality Head (Sterile formulations)

Designation: GM/ (Site Quality Head) – Sterile Formulations

Position Overview

We are seeking a highly experienced Site Quality Head to lead the quality function at our Hyderabad sterile formulations facility. The incumbent will be responsible for overseeing Quality Assurance (QA) Quality Control (QC) and Microbiology functions ensuring compliance with global regulatory standards and driving a culture of quality excellence across the site.

Key Responsibilities

• Leadership & Oversight

  • Head the site’s QA QC and Microbiology departments ensuring seamless integration of quality systems.
  • Provide strategic direction to quality teams fostering a culture of compliance accountability and continuous improvement.

• Regulatory Compliance & Audits

  • Lead preparation and direct handling of USFDA EMA MHRA and other global regulatory audits.
  • Ensure site readiness for inspections and maintain robust documentation practices.
  • Drive corrective and preventive actions (CAPA) and ensure timely closure of audit observations.

• Quality Systems Management

  • Oversee batch release deviation management change control and risk assessments.
  • Ensure sterility assurance and contamination control strategies are implemented effectively.
  • Monitor and enhance site-wide GMP compliance.

• Operational Excellence

  • Collaborate with manufacturing engineering and supply chain teams to ensure product quality and regulatory compliance.
  • Implement best practices in sterile manufacturing including aseptic techniques and cleanroom operations.
  • Drive continuous improvement initiatives to enhance efficiency and reduce compliance risks.

• Stakeholder Engagement

  • Act as the primary quality representative for site leadership and global corporate teams.
  • Build strong relationships with regulatory authorities clients and internal stakeholders.

Qualifications & Experience

• Education: Master’s degree in Pharmacy Biotechnology Microbiology or related discipline.
• Experience:
  • 18 years of total experience in pharmaceutical quality functions.
  • Minimum 3–4 years as Site Quality Head in sterile formulations.
  • Proven track record of directly handling USFDA audits with successful outcomes.
• Skills:
  • Strong expertise in sterile manufacturing aseptic processing and microbiological controls.
  • Excellent leadership communication and stakeholder management skills.
  • Deep knowledge of global regulatory requirements (USFDA EMA MHRA WHO).

Competencies

• Strategic leadership with hands-on regulatory expertise.
• Ability to manage complex quality operations in a sterile environment.
• Strong decision-making and problem-solving skills under audit pressure.
• Commitment to compliance integrity and patient safety.

Performance Metrics

• Successful completion of regulatory audits (USFDA EMA MHRA).
• Zero critical observations in inspections.
• Timely batch release and compliance with sterility assurance standards.
• Continuous improvement in site quality KPIs.

Required Skills:

QA Site quality HeadsterileinjectablesQuality assurance Head