Site Compliance Leader: Quality, GMP & Regulatory

GSK; Karachi Division; On-site; PKR 2,400,000 - 3,600,000; Full time

Job summary

GSK Pakistan seeks a compliance leader to own the site’s quality, regulatory and cGMP programs, collaborating with QA, manufacturing, regulatory and business teams to identify risks, implement corrective actions, and sustain the site’s License to Operate.

You will drive internal audits, CAPA, change control, KPIs, and a proactive compliance culture, ensuring readiness for inspections and alignment with global QMS standards.

Qualifications

• Minimum 5 years of experience in Quality Assurance, Compliance or Quality Control with leadership responsibilities.
• Relevant degree in sciences, pharmacy, MS or equivalent practical experience.
• Experience supporting inspections & audits.
• Strong problem solving and risk assessment skills.
• Good verbal and written communication skills in English.
• Leadership and management skills.
• Experience with change control, CAPA, and quality management systems.
• Ability to prepare technical documentation.
• Experience using quality systems tools and dashboards.
• Proficient in Word, Excel & PowerPoint for reporting.

Responsibilities

• Lead site compliance programs and maintain readiness for inspections.
• Assess compliance risk, drive CAPAs, and monitor closure.
• Support change control and regulatory impact assessments for changes.
• Coach and influence peers to build a proactive compliance culture.
• Conduct internal audits to assess manufacturing and quality processes for compliance and facilitate CAPA generation.
• Manage Local Incident Management and Product Incident and Recall.
• Ensure KPIs are available to measure compliance effectiveness and drive improvements.
• Develop site auditor capabilities and ensure safety and quality standards.
• Sustain Site Quality Risk Model and drive improvements.
• Oversee QMS implementation and build engagement to strengthen QMS.
• Maintain License to Operate and manage regulatory inspections (cGMP, DML, etc.).
• Manage third-party and ISO audits.
• Ensure compliance of Post Inspection Assessments, QRI, Quality Bulletins and Alerts; mitigate risks.
• Responsible for Record Retention & Documentation Management.

Skills

Quality Assurance

Risk Assessment

Regulatory Compliance

Leadership

Change Control

CAPA

Data Analysis

Education

Science or Pharmacy degree

MS or equivalent practical experience

Tools

MS Office

Quality Systems Tools

Job description

GSK Pakistan seeks a compliance leader to own the site’s quality, regulatory and cGMP programs, collaborating with QA, manufacturing, regulatory and business teams to identify risks, implement corrective actions, and sustain the site’s License to Operate.

You will drive internal audits, CAPA, change control, KPIs, and a proactive compliance culture, ensuring readiness for inspections and alignment with global QMS standards.