Quality Specialist

Role Overview

The Quality Specialist is accountable for maintaining robust quality oversight across the Contract Development and Manufacturing Organization’s (CDMO) Quality Management System (QMS), project executions, and laboratory operations. This role guarantees the active management of quality systems meeting regulatory and client standards, while fostering a culture centered on accountability, data integrity, inspection preparedness, and ongoing enhancement.

Key Responsibilities

• Lead and govern the CDMO's QMS to assure continuous compliance, efficiency, and improvements.
• Manage vital processes such as document control, change control, deviation handling, investigations, and corrective and preventive actions (CAPAs).
• Oversee activities to prepare for audits and ensure timely resolution of audit-related findings.
• Monitor training adherence, vendor assessments, and regulatory compliance.
• Track quality performance metrics and facilitate initiatives for continuous quality advancement.
• Provide impartial quality oversight on projects, ensuring outputs comply with standards and client expectations.
• Collaborate with project teams to set and enforce quality requirements.
• Review and sanction project documents throughout their lifecycle.
• Ensure adherence to ALCOA+ principles, data integrity, and relevant quality benchmarks.
• Lead project-associated investigations, deviations, CAPAs, and training facilitation.
• Grant final quality approval on project results and client deliverables.
• Maintain laboratory operations within compliance parameters including SOPs, GDP, ALCOA+, equipment qualifications, and calibrations.
• Engage regularly in laboratory governance and manage escalation of quality risks.
• Support audit activities and inspection readiness within lab settings.
• Champion a quality-driven environment through coaching, advice, and continuous improvement strategies.

Candidate Profile

Essential Qualifications: A degree in Science, Engineering, Pharmaceutical Sciences, Quality, or a comparable field. Additional certifications or training in Quality Management Systems, auditing, GMP, GDP, Quality Risk Management, Data Integrity, or Continuous Improvement are advantageous.

Experience Requirements: Background in pharmaceutical, biopharmaceutical, laboratory, R&D, CDMO, or other regulated sectors. Proven experience managing or supporting quality system processes including document control, deviation handling, investigations, CAPA management, audits, change control, and training oversight. Experience providing quality supervision for laboratory operations and project deliverables, along with interaction with clients, auditors, regulatory inspectors, suppliers, and cross-functional teams.

Skills and Competencies: Solid grasp of Quality Management Systems and GMP/GDP requirements. Proficient in ALCOA+ Data Integrity and Quality Risk Management principles. Expertise in root cause analysis, investigative techniques, problem-solving, and CAPA processes. Detail-oriented review skills for technical and quality documentation. Strong communication, stakeholder engagement, and influence capabilities. Ability to appropriately challenge practices and escalate quality and compliance risks as necessary. Familiarity with electronic Quality Management Systems (eQMS) and digital quality tools.