Compliance Manager

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

Job summary

GSK seeks a senior QA/compliance lead at our Pakistan site to own compliance programs, manage regulatory inspections, and drive CAPA for quality and safety. You will collaborate with quality, manufacturing, regulatory, and business teams to sustain cGMP and QMS adherence.

The role requires strong risk assessment, problem-solving, and leadership to promote a proactive compliance culture across sites, with clear decision making and cross-functional engagement.

Qualifications

• Minimum 5 years of experience in QA or compliance or QC with leadership.
• Experience supporting inspections and audits.
• Strong problem solving and risk assessment skills.
• Excellent verbal and written English communication.
• Leadership and management experience.
• Experience with change control, CAPA, and QMS.
• Ability to prepare technical documentation.
• Experience using quality systems tools and dashboards.
• Proficient in Word, Excel and PowerPoint for reports.

Responsibilities

• Lead site compliance programs and readiness for inspections.
• Assess compliance risk, drive CAPA, and monitor closure.
• Support change control and regulatory impact for changes.
• Coach and influence colleagues to build a proactive compliance culture.
• Conduct internal audits to assess manufacturing and quality processes; drive CAPAs.
• Manage Local Incident Management and Product Incident and Recall.
• Ensure KPIs for compliance; identify and resolve non-conformances.
• Build capability of site auditors and uphold Safety and Quality standards.
• Maintain Site Quality Risk Model sustainability and improvement.
• Lead overall QMS implementation and engagement activities.
• Maintain License to Operate and manage regulatory inspections.
• Manage third-party and ISO audits.
• Ensure compliance of post-inspection assessments and QRI; mitigate risks.
• Oversee Record Retention & Documentation Management.

Skills

Data Integrity

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Sciences degree

Pharmacy degree

MS or equivalent

Tools

Quality systems tools

Performance dashboards

MS Office (Word/Excel/PowerPoint)

Job description

You will lead and own compliance activities at our Pakistan site to ensure safe, ethical, and reliable operations. You will work closely with quality, manufacturing, regulatory, and business teams to identify risks, set standards, and resolve compliance issues with respect to QMS requirements, cGMP standards & local regulatory requirement. We value clear decision making, practical problem solving, and open collaboration. This role offers strong career growth, real impact on patient safety, and a chance to help unite science, technology and talent to get ahead of disease together.

Responsibilities

• Lead site compliance programs and maintain readiness for inspections.
• Assess compliance risk, drive corrective and preventive actions, and monitor closure.
• Support change control and ensure regulatory impact is assessed for technical changes.
• Coach and influence colleagues to build a proactive compliance culture across teams.
• Responsible for internal audits to assess the manufacturing and quality processes for compliance and to ensure processes and controls are in place, in use and effective and facilitate the generation of Corrective And Preventive Actions (CAPA) that prevent re-occurrence of issues.
• Manage Local Incident Management and Product Incident and Recall
• Ensure that KPIs are available to assure the compliance effectiveness. Ensure that non-conformances are identified and resolved. Monitor and review performance measures and drives improvement.
• Build capability of site auditors (management monitoring) and adhere to Safety and Quality standards.
• Responsible to ensure Site Quality Risk Model sustainability and improvement.
• Manage the overall QMS implementation process and Support in building communication and engagement activities to promote and strengthen QMS along.
• Maintain License to Operate and manage regulatory inspection pertaining to cGMP Certificate, DML Inspection etc.
• Manage third-party & ISO audits
• Ensure compliance of Post Inspection Assessments, Quality regulatory Intelligence (QRI) , Quality Bulletin and Quality Alerts requirements at site and elimination of pertinent risks.
• Responsible for Record Retention & Documentation Management.

Education, Experience And Skills

• Minimum 5 years of Experience in Quality Assurance or Compliance or Quality Control, or a related field, including a position of leadership and decision-making authority within Quality or a related function.
• 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.
• Good leadership and management skills
• Practical experience with change control, CAPA, and quality management systems.
• Ability to prepare technical documentation.
• Experience using quality systems tools and performance dashboards.
• Computer Skills (Working on Word, Excel & Power point) to make reports, updates summaries of results & presents data to higher management for review.

Skills

• Data Integrity
• Digital Fluency
• GxP Regulations
• Influencing Without Authority
• Lean Management
• Pharmaceutical Regulatory Compliance
• Problem Solving
• Quality Assurance (QA)
• Risk Awareness
• Technical Writing

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.

People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.