Contract: 1-Year Fixed Term

Role Overview

The Senior Quality Assurance (QA) Specialist is responsible for managing and executing QA operational tasks within the Pharmaceutical Quality System (PQS). This role involves close collaboration with Operations, Supply Chain, Quality Control, and Engineering to ensure compliance and drive continuous improvement initiatives. Additionally, the Senior QA Specialist will provide leadership, oversee direct reports, and contribute to a high-performance quality culture.

Key Responsibilities

Quality System Management & Oversight

• Act as the QA SME for PQS systems, including deviations, change control, complaints, validation, and risk management.

• Review and approve Standard Operating Procedures (SOPs) and other controlled documents.

• Develop and maintain QA SOPs and controlled documentation.

• Identify and implement continuous quality system improvements across GxP compliance, deviation management, preventive maintenance, and change control programs.

• Lead and facilitate Quality Risk Management (QRM) activities in alignment with ICH Q9 rev1.

Leadership & Staff Development

• Manage and mentor QA Specialist reports, fostering a high-performance quality culture.

• Develop and own Quality Metrics, using data-driven insights to improve quality record completion and operational efficiency.

• Support the Quality Manager, QP, and Head of Quality in achieving PQS objectives and continuous improvement.

Batch Documentation & Release Support

• Provide expert guidance on master batch documentation development.

• Review and approve executed batch documentation.

• Establish and maintain processes supporting QP teams in quality record preparation, review, and release documentation.

Supplier & Manufacturing Oversight

• Provide QA oversight for on-site manufacturing, materials management, warehousing, and quality control testing.

• Oversee QA activities at approved service providers (QC testing, material storage, supply).

• Prepare and review Quality Agreements with service providers.

• Conduct Supplier GxP Monitoring during onboarding and throughout the lifecycle.

Regulatory Compliance & Inspection Readiness

• Contribute to and execute inspection readiness activities.

• Participate in regulatory inspections, interact with inspectors, and ensure follow-up on observations.

• Support the development of QA capabilities and services to enhance service delivery and commercial revenue opportunities, such as supplier quality management.

Experience & Qualifications

Essential Requirements:

• Minimum 5 years’ experience in cGMP pharmaceutical operations, with direct exposure to quality systems.

• Degree in a scientific discipline or equivalent qualification.

• Strong decision-making skills, particularly within complex regulatory frameworks.

• Proven ability to work independently and flexibly, driving a high-performance quality culture.

Preferred Experience (Advantageous):

• Supplier Quality Management activities.

• Quality Risk Management (QRM) experience, especially in leading or facilitating QRM activities.

• Knowledge of Good Distribution Practice (GDP).

• Experience in managing and developing staff.