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Head of Quality Operations
4 weeks ago
Job Title: Head of Quality Operations
Industry: Pharmaceutical Manufacturing
Location: Karachi, Pakistan
Experience: 15+ years in Quality Assurance (QA) and Quality Control (QC)
Education: Pharm-D, M.Sc. Chemistry, or a related discipline. Advanced certifications in Quality Management or Regulatory Affairs are a plus.
Age Bracket: 40-50 years
We are seeking a Head of Quality Operations to lead and oversee Quality Assurance (QA) and Quality Control (QC) functions for a leading pharmaceutical manufacturer in Karachi. The role requires expertise in implementing international quality standards and certifications, ensuring compliance with GMP, WHO, FDA, EU, and GCC regulatory requirements. The ideal candidate will bring extensive GCC pharma manufacturing experience and a strong background in quality leadership.
Key Responsibilities:- Develop and implement quality strategies aligned with international regulatory requirements to ensure compliance and continuous improvement.
- Oversee and manage QA and QC operations, ensuring the highest standards of product quality and safety.
- Ensure successful certification and compliance with international standards such as GMP, WHO, FDA, EU, and SFDA (Saudi Food & Drug Authority).
- Lead internal and external regulatory audits and inspections, addressing any non-compliance issues effectively.
- Monitor quality control processes across all manufacturing operations, ensuring adherence to validated procedures.
- Implement risk management and quality improvement initiatives to enhance product reliability and reduce defects.
- Provide strategic leadership and training to the quality team, fostering a culture of continuous improvement.
- Collaborate with R&D, manufacturing, and regulatory affairs teams to ensure smooth product development and compliance.
- Stay updated on global quality trends and regulatory changes, advising management on necessary adjustments.
- 15+ years of experience in Quality Assurance and Quality Control, with at least 5 years in a leadership role.
- In-depth knowledge of pharmaceutical manufacturing regulations, particularly in GCC markets.
- Strong experience in international quality certifications and compliance (GMP, WHO, FDA, EU, SFDA).
- Proven track record in managing audits, regulatory inspections, and implementing CAPA (Corrective and Preventive Actions).
- Ability to lead and mentor cross-functional teams to drive quality excellence.
- Strong analytical, problem-solving, and decision-making skills.
This is a Karachi-based leadership role offering a challenging opportunity for experienced quality professionals in the pharmaceutical industry.
Only shortlisted candidates will be contacted.
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