Head of Quality

7 days ago

Lahore, Punjab, Pakistan The HRM Navigator Full time

The Head of Quality is responsible for leading, managing, and continuously improving all Quality Assurance (QA), Quality Control (QC), and Compliance functions within the organization. This role ensures that all pharmaceutical products are developed, manufactured, tested, and released in compliance with cGMP, DRAP, WHO, and other applicable regulatory standards. The incumbent will drive a culture of quality, compliance, and continuous improvement across all departments.

Key Responsibilities:

  • Provide strategic leadership and direction to the QA and QC departments, ensuring alignment with company goals and regulatory expectations.
  • Oversee all quality systems, including documentation control, deviation and CAPA management, change control, validation, and self-inspection programs.
  • Ensure compliance with cGMP, DRAP, WHO, and international quality guidelines for pharmaceutical manufacturing.
  • Manage product release and ensure that all batches meet established specifications and regulatory requirements before distribution.
  • Establish and monitor key performance indicators (KPIs) for quality processes and implement continuous improvement initiatives.
  • Review and approve all quality-related documentation, including SOPs, validation protocols/reports, and specifications.
  • Lead internal and external audits (including DRAP, WHO, and client audits) and ensure timely closure of findings.
  • Develop and implement training programs to promote quality awareness and compliance culture throughout the organization.
  • Liaise with R&D, Production, Supply Chain, and Regulatory Affairs to ensure quality integration at all stages of product lifecycle.
  • Ensure effective vendor qualification and raw material quality management.
  • Oversee environmental monitoring, laboratory testing, and stability programs.
  • Prepare and present periodic quality performance reports to senior management.

Qualifications & Experience:

  • Education: Pharm-D or M.Phil. (Pharmaceutics / Quality Assurance) from a recognized university.
  • Experience: Minimum 10–15 years of progressive experience in Quality Assurance and Quality Control, with at least 5 years in a senior leadership role within a reputed pharmaceutical manufacturing company.
  • Knowledge: Strong understanding of cGMP, DRAP regulations, WHO guidelines, ICH Q-series, and ISO standards.

Core Competencies:

  • Leadership and people management
  • Strong analytical and decision-making skills
  • In-depth understanding of pharmaceutical manufacturing processes
  • Excellent audit, inspection, and documentation skills
  • Strategic planning and problem-solving ability
  • Effective communication and cross-functional collaboration

Key Deliverables:

  • Zero critical regulatory observations during inspections
  • On-time closure of deviations, CAPAs, and change controls
  • Continuous improvement in product quality metrics and compliance score
  • Training and development of quality teams

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