Our client, a prominent pharmaceutical manufacturer based in Karachi, is seeking a seasoned and strategic Head of Compliance to lead their Quality Compliance function. This leadership role involves developing, standardizing, and managing compliance frameworks while driving the Quality Management Systems (QMS) to ensure that all manufacturing and operational activities comply with both local and international regulatory standards. The ideal candidate will align compliance initiatives with the company’s business objectives, ensuring regulatory adherence and operational excellence.
Key Responsibilities
- Develop, implement, and maintain comprehensive compliance frameworks across the organization.
- Lead and oversee the Quality Management Systems (QMS) to ensure continuous improvement and regulatory compliance.
- Ensure all manufacturing and operational processes strictly adhere to local regulatory requirements, including DRAP regulations, as well as international standards such as cGMP.
- Prepare the organization for regulatory audits and inspections, coordinating with relevant departments to address findings and implement corrective actions.
- Manage validation protocols and ensure documentation meets regulatory expectations.
- Collaborate with cross-functional teams to embed compliance culture and promote best practices throughout the manufacturing plant.
- Monitor changes in regulatory guidelines and update policies and procedures accordingly.
- Provide leadership and mentorship to the compliance team, fostering a high-performance environment.
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 facility.
- Strong expertise in DRAP regulations, current Good Manufacturing Practices (cGMP), regulatory audit preparation, Quality Management Systems, and validation protocols.
Preferred Qualifications and Additional Skills
- Exposure to international regulatory frameworks such as PIC/S, EU, WHO, and ICH guidelines is highly desirable.
- Excellent communication skills, both verbal and written, to effectively interact with internal teams and external regulatory bodies.
- Strong analytical abilities to assess compliance risks and implement effective solutions.
- Proven team management skills with the ability to lead and motivate a diverse team.
This opportunity offers a chance to join a leading pharmaceutical manufacturer with a broad product portfolio involved in manufacturing, marketing, and exports. The organization values compliance as a key driver of quality and business success and seeks a dedicated professional to uphold these standards.
HR Capital Consultants, a team of experienced HR professionals, is supporting this recruitment. They specialize in providing expert HR consultancy services across Pakistan, including recruitment, payroll, HR software, and employee training and development solutions.