Assistant Manager - Global Quality Management System

Why This Role Matters

The Assistant Manager – Global QMS plays a strategic role in ensuring consistent quality standards across multiple sites within a regulated pharmaceutical or biotechnology organisation. A robust Global Quality Management System (QMS) is the backbone of regulatory compliance, operational excellence, and product reliability. This role ensures that quality frameworks are not only implemented but continuously improved to meet evolving global regulatory expectations.
By overseeing document review, regulatory compliance monitoring, audit participation, and quality trend analysis, this position safeguards product integrity and patient safety on a global scale. The role bridges site-level operations with corporate quality objectives, ensuring alignment with GMP, ISO, ICH, FDA, WHO, and other applicable regulatory frameworks.
Through strong governance, oversight, and collaboration with cross-functional teams, the Assistant Manager – Global QMS strengthens organisational readiness for inspections and drives a culture of quality excellence across the enterprise.

Job Description

The Assistant Manager – Global QMS is responsible for supporting the implementation, maintenance, and continuous improvement of the Global Quality Management System across all company sites. The role ensures alignment with internal standards and international regulatory requirements.
The position requires active involvement in reviewing and approving quality documents, tracking regulatory commitments, supporting audits and inspections, and monitoring key quality metrics. The individual will collaborate with site Quality Assurance teams to ensure consistent interpretation and application of global quality standards.
This role is ideal for experienced Quality Assurance professionals with strong exposure to global QMS frameworks within pharmaceutical, biotechnology, or other highly regulated industries.

Key Features of the Role:

• Position: Assistant Manager – Global QMS
• Department: Quality Assurance
• Qualification: M.Sc or M.Pharm
• Experience Required: 9–12 years in QA / Global QMS
• Industry: Pharmaceutical / Biotech / Regulated Industry
• Exposure to global regulatory authorities (FDA, WHO, ICH, ISO, GMP)
• Enterprise-wide quality system oversight
• Opportunity to contribute to global compliance strategy

Responsibilities

• Ensure effective implementation and compliance of the Global Quality Management System across all sites
• Review and approve quality documents including SOPs, policies, deviations, CAPAs, change controls, and risk assessments
• Monitor adherence to global regulatory guidelines such as GMP, ISO, ICH, FDA, WHO, and local regulations
• Track regulatory commitments and ensure timely closure of action items
• Support and participate in internal audits, external audits, and regulatory inspections
• Perform trend analysis of deviations, complaints, OOS/OOT events, and assess CAPA effectiveness
• Coordinate with site QA teams to standardise interpretation and implementation of QMS procedures
• Prepare quality metrics, dashboards, and reports for management review meetings
• Drive continuous improvement initiatives within the Global QMS framework
• Identify gaps in quality systems and recommend corrective and preventive actions
• Maintain inspection readiness across all operational sites
• Support enterprise-level quality governance and compliance initiatives

Required Qualifications

The ideal candidate is a seasoned Quality Assurance professional with strong exposure to global quality systems and regulatory compliance frameworks.

Educational Requirements:

• M.Sc in a relevant Life Sciences discipline OR
• M.Pharm
• Strong foundation in pharmaceutical quality systems and regulatory science

Experience and Skills:

• 9–12 years of relevant experience in Quality Assurance or Global QMS
• Strong knowledge of global QMS frameworks and regulatory expectations
• In-depth understanding of GMP and pharmaceutical quality systems
• Experience handling audits and regulatory inspections
• Strong analytical and problem-solving capabilities
• Experience in deviation management, CAPA evaluation, and risk assessment
• Proficiency in documentation control and quality metrics reporting
• Ability to collaborate with cross-functional and multi-site teams
• Strong written and verbal communication skills
• Capability to drive quality improvements at an organisational level

Salary Insights

Compensation will be aligned with industry benchmarks and commensurate with experience and expertise in Global QMS and regulatory compliance. Senior-level exposure to enterprise-wide quality systems typically commands competitive remuneration packages, along with performance-based growth opportunities.

Company Overview

Enzene is an innovation-driven pharmaceutical organisation committed to redefining healthcare solutions through advanced science and technology. The company focuses on regulatory excellence, operational efficiency, and a strong culture of quality.
At Enzene, employees are regarded as the organisation’s most valuable asset. The company fosters a forward-thinking environment driven by pioneers who are dedicated to disrupting the pharmaceutical industry through innovation while maintaining stringent global quality and compliance standards.

FAQs

Q1. Is prior Global QMS experience mandatory?
Yes, candidates should have substantial exposure to Global QMS or enterprise-level quality systems.

Q2. What regulatory knowledge is expected?
Strong understanding of GMP, ISO, ICH, FDA, WHO, and other applicable regulatory guidelines is required.

Q3. Does the role involve audit participation?
Yes, the role includes participation in internal audits, external audits, and regulatory inspections.

Q4. Is this a site-level or global role?
This is a global-level role supporting quality system implementation across all sites.

Q5. What type of industry experience is preferred?
Experience in pharmaceutical, biotechnology, or other regulated industries is preferred.

Application Tips

• Highlight enterprise-level QMS implementation experience
• Mention audit and regulatory inspection exposure
• Provide examples of managing deviations, CAPA, and risk assessments
• Showcase experience preparing quality dashboards and management reports
• Demonstrate cross-functional and multi-site coordination skills
• Emphasise continuous improvement initiatives you have led