Job Description

Our client, a leading pharmaceutical manufacturing company, is seeking an experienced Quality Assurance (QA) Systems Lead to drive excellence in quality assurance operations. This role is key to ensuring full compliance with industry standards while leading initiatives that continuously improve processes, systems, and outcomes.
Key Responsibilities:

• Coordinate and manage annual internal, external, and vendor audit programmes, ensuring effective planning, execution, and reporting.
• Oversee QMS systems and tools, ensuring risk assessments are conducted, changes are properly documented, and document/record control is maintained.
• Maintain, review, and report on QMS systems, processes, and procedures in line with QA objectives and regulatory requirements.
• Identify, track, and report on quality metrics, implementing continuous improvement initiatives where required.
• Lead, mentor, and manage a team of QA professionals, driving performance, professional development, and a quality-focused culture across the organisation.
• Represent the QA department in cross-functional initiatives and management meetings, and set annual quality objectives.
• Manage and enhance the SAP QM system, ensuring notifications are correctly created, workflows managed, and training provided.
• Draft and review User Requirements Specifications for system changes, supporting IT during implementations.
• Ensure QMS procedures are consistently implemented, reviewed, and followed, with ongoing training provided.
• Lead GMP audit activities, analysing trends, escalating issues where necessary, and ensuring effective audit reporting.
• Oversee the document management system (SAP DMS and SharePoint), ensuring compliance and operational continuity.
• Manage the change control system, ensuring GMP-related changes are properly evaluated, documented, implemented, and reviewed.
• Drive process risk assessments and mitigation strategies, maintaining risk registers and facilitating periodic reviews.
• Monitor retention samples and material status within the QMS to ensure GMP compliance.
• Stay up to date with regulatory guidelines and industry changes, ensuring internal alignment.
• Support QA contributions to regulatory submissions, SHE audits, and internal investigations.

Minimum Requirements:

• Bachelor's degree in Chemical Engineering, Chemistry, Biochemistry, Biological or Pharmaceutical Sciences, or a related technical/scientific field.
• At least 5 years' experience in pharmaceutical manufacturing or pharmaceutical quality, with strong knowledge of facilities, equipment, laboratories, and Quality Management Systems.
• 2+ years' experience in supervising/leading teams.
• 2+ years' experience as an auditor of quality systems (ISO9001, ISO13485 and/or GMP).
• Experience with ISO13485:2016 is advantageous.
• Strong working knowledge of cGMP and QMS frameworks, with proven experience in audits, document control, and change management.

Specific SHE Requirements:

• Pre-employment, routine, and exit medicals are compulsory due to the nature of the business.
• Mandatory attendance at SHE-related training.
• Adherence to SHE instructions and site rules.
• Ability and willingness to work with hazardous and biologically active chemicals, with the required PPE and medical examinations (per OSH Act).

Core Competencies:

• Strong leadership with the ability to influence, mentor, and build quality-driven teams.
• Excellent interpersonal skills with the ability to manage relationships across all levels of the business.
• Analytical mindset with strong problem-solving skills and attention to detail.
• Ability to manage projects and work independently with minimal supervision.
• Effective communicator, able to encourage teams to adopt process-oriented thinking.
• Strong technical writing skills and confident presentation abilities.
• High levels of personal leadership, initiative, and self-motivation.