Compliance Manager

GlaxoSmithKline; Karachi Division; On-site; PKR 1,800,000 - 3,000,000; Full time

Job summary

GlaxoSmithKline in Pakistan seeks a Site Compliance Lead to own and advance compliance programs, ensuring QMS alignment with cGMP and local regulatory requirements. You will work with quality, manufacturing, regulatory and business teams to identify risks, implement CAPAs, and maintain inspection readiness.

You will influence a culture of proactive quality, lead audits, and sustain the License to Operate while delivering data-driven performance measures to leadership.

Qualifications

• Minimum 5 years of Experience in Quality Assurance or Compliance or Quality Control, including leadership and decision-making authority.
• Relevant degree in sciences, pharmacy, MS or equivalent practical experience.
• Experience supporting inspections & audits.
• Strong problem solving and risk assessment skills.

Responsibilities

• Lead site compliance programs and readiness for inspections.
• Assess compliance risk, drive CAPAs, 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 manufacturing and quality processes for compliance and to ensure processes and controls are in place and effective; facilitate CAPA generation.
• Manage Local Incident Management and Product Incident and Recall; ensure KPIs show compliance effectiveness.
• Ensure non-conformances are identified and resolved; monitor performance measures and drive improvement.
• Build capability of site auditors and maintain Site Quality Risk Model; manage overall QMS implementation and regulatory inspections.

Skills

Data Integrity

Digital Fluency

GxP Regulations

Influencing Without Authority

Lean Management

Pharmaceutical Regulatory Compliance

Problem Solving

Quality Assurance

Risk Awareness

Technical Writing

Education

Science or Pharmacy degree

Tools

Quality Systems Tools

Performance Dashboards

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

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.

We are a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Find out more on our career site.