About the job

Role Purpose

The Quality Specialist is responsible for providing robust quality oversight across the CDMO's Quality Management System (QMS), project delivery, and laboratory operations. The role ensures that quality systems are actively maintained, regulatory and client expectations are met, and a strong culture of accountability, data integrity, inspection readiness, and continuous improvement is embedded across the organization.

Key Responsibilities

System Ownership & Management

Provide leadership and governance of the CDMO's Quality Management System to ensure ongoing compliance, effectiveness, and continuous improvement.

• Own and continuously improve the CDMO's QMS and associated quality processes.
• Manage document control, change control, deviations, investigations, and CAPAs.
• Lead audit readiness activities and ensure timely closure of audit actions.
• Oversee training compliance, vendor qualification, and regulatory requirements.
• Monitor quality metrics and drive continuous improvement initiatives.

Project Quality Oversight

Provide independent quality oversight of projects to ensure delivery of compliant, accurate, and client-ready outputs.

• Partner with project teams to define and implement project quality requirements.
• Review and approve project documentation throughout the project lifecycle.
• Ensure compliance with ALCOA+, data integrity, and applicable quality standards.
• Lead project-related investigations, deviations, CAPAs, and training activities.
• Maintain final quality approval of project deliverables and client-facing outputs.

Laboratory Operations Quality Oversight

Ensure laboratory operations are performed in accordance with regulatory, quality, and data integrity requirements.

• Provide routine quality oversight of laboratory activities and documentation.
• Ensure compliance with SOPs, GDP, ALCOA+, equipment qualification, and calibration requirements.
• Participate in laboratory governance forums and manage quality risk escalation.
• Support compliance audits and inspection readiness activities.
• Promote a culture of quality through coaching, guidance, and continuous improvement.

Note: The scope of responsibilities assigned within this role may vary depending on the successful candidate's level of experience, knowledge, and demonstrated capability.

Candidate Profile

Qualifications

• Degree in Science, Engineering, Pharmaceutical Sciences, Quality, or a related discipline.
• Additional qualifications or training in Quality Management Systems, auditing, GMP, Good Documentation Practices (GDP), Quality Risk Management, Data Integrity, or Continuous Improvement are desirable.

Experience

• Experience within a pharmaceutical, biopharmaceutical, laboratory, R&D, CDMO, or other regulated environment.
• Experience managing or supporting quality system processes, including document control, deviations, investigations, CAPA, audits, change control, and training management.
• Experience providing quality oversight of laboratory activities and project execution.
• Experience interacting with clients, auditors, inspectors, suppliers, and cross-functional teams.

Skills & Knowledge

• Strong understanding of Quality Management Systems and GMP/GDP requirements.
• Knowledge of ALCOA+ Data Integrity principles and Quality Risk Management methodologies.
• Strong root cause analysis, investigation, problem-solving, and CAPA management skills.
• Ability to review technical and quality documentation with exceptional attention to detail.
• Strong communication, stakeholder management, and influencing skills.
• Ability to challenge appropriately and escalate quality and compliance risks when required.
• Experience with electronic quality systems (eQMS) and digital quality platforms.
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