Our client, a prominent pharmaceutical manufacturer based in Karachi, is seeking a seasoned and strategic Head of Compliance to lead their Quality Compliance function. The ideal candidate will play a critical role in establishing, standardizing, and managing compliance frameworks while driving the Quality Management Systems (QMS) across the organization. This leadership position requires ensuring that all manufacturing and operational activities comply rigorously with both local and international regulatory standards, while also aligning with the company’s broader business goals.
Key Responsibilities:
- Develop, implement, and maintain robust compliance frameworks to support quality assurance and regulatory adherence.
- Lead and oversee the Quality Management Systems (QMS) to ensure continuous improvement and regulatory compliance.
- Ensure all manufacturing processes and operational practices comply with local regulations such as DRAP, as well as international standards including cGMP.
- Conduct and supervise risk-based audits, manage Corrective and Preventive Actions (CAPA), and oversee validation protocols.
- Collaborate with cross-functional teams to align compliance initiatives with business objectives and operational strategies.
- Stay updated with evolving regulatory guidelines and ensure the organization’s practices reflect the latest standards.
- Mentor and manage the compliance team, fostering a culture of quality and accountability throughout the organization.
Required Qualifications:
- Pharma-D, B-Pharm, or MSc in a relevant discipline.
- 15 to 20 years of core pharmaceutical industry experience, with a minimum of 6 years in a senior managerial or leadership role within a reputable pharmaceutical manufacturing plant.
- Comprehensive knowledge of DRAP regulations, current Good Manufacturing Practices (cGMP), risk-based audits, CAPA, QMS, and validation protocols.
- Strong communication, analytical, and team management skills essential for effective leadership and stakeholder engagement.
Preferred Qualifications and Benefits:
- Exposure to international regulatory frameworks such as PIC/S, EU, WHO, and ICH guidelines is highly desirable and will be considered an advantage.
- Opportunity to lead compliance in a well-established pharmaceutical company with a diverse product portfolio engaged in manufacturing, marketing, and exports.
- Work within a dynamic environment that values quality, regulatory excellence, and continuous professional development.
This role offers a unique opportunity for an experienced compliance professional to contribute significantly to a leading pharmaceutical manufacturer’s quality assurance and regulatory success. The organization is committed to maintaining the highest standards in pharmaceutical manufacturing and seeks a leader who can uphold and enhance these standards through strategic compliance management.