Senior Quality Operations Specialist

Senior Quality Operations Specialist

Build your future at Curia, where our work has the power to save lives.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

We proudly offer:

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

The Senior Quality Operations Specialist is a senior individual contributor within the Quality organization and serves as the Quality Assurance subject matter expert and quality approver for validation, qualification, engineering, facilities, utilities, computerized systems and manufacturing-related activities. This role provides independent quality oversight and approval of validation lifecycle deliverables, including protocols, reports, deviations, change controls, and associated controlled documentation supporting facility expansion projects, new technology implementation, equipment qualification and commercial manufacturing operations.

The position partners closely with Engineering, Validation, Facilities, Manufacturing, and Technical Operations to ensure activities are executed in compliance with cGMP requirements, regulatory expectations, and company quality systems. The Senior Quality Operations Specialist applies risk-based decision making and sound quality judgment to assess compliance, resolve quality issues and support successful project execution while maintaining product quality, patient safety and inspection readiness.

As a recognized technical expert, this role provides guidance and consultation on validation strategy, quality system requirements, and industry best practices. The individual serves as a key quality representative during customer audits, regulatory inspections, and cross-functional project activities, ensuring quality considerations are effectively integrated into business and operational decisions.

Essential Duties and Responsibilities:

• Serve as the Quality Assurance subject matter expert and quality approver for validation, qualification, commissioning, engineering, facilities, utilities, computerized systems and manufacturing-related activities.
• Provide independent quality oversight and approval of validation lifecycle deliverables, including protocols, reports, deviations, change controls, risk assessments, commissioning documents, Validation Master Plans and associated controlled records.
• Ensure validation and qualification activities are designed and executed in compliance with applicable cGMP regulations, company procedures, regulatory expectations, and industry best practices.
• Partner with Engineering, Validation, Facilities, Manufacturing, Technical Operations, and other functional groups to provide quality guidance and oversight for capital projects, facility expansions, equipment installations, process improvements and technology transfers.
• Assess quality and compliance risks associated with validation, engineering and manufacturing activities and provide risk-based recommendations to support sound business and quality decisions.
• Review and approve qualification, validation, requalification, and revalidation documentation for facilities, utilities, equipment, manufacturing processes and computerized systems.
• Provide quality oversight for the development, revision, and maintenance of Validation Master Plans, validation strategies and technical documentation supporting regulatory submissions and commercial manufacturing operations.
• Lead and support investigations related to validation, qualification and engineering activities, ensuring appropriate root cause analysis, impact assessments, corrective actions and effectiveness verification.
• Support inspection readiness activities and serve as a quality representative during customer audits, regulatory inspections and due diligence assessments related to validation, facilities, engineering and manufacturing systems.
• Provide technical expertise and guidance regarding quality systems, validation principles, data integrity requirements and regulatory expectations to cross-functional teams.
• Identify opportunities to improve validation compliance, quality system effectiveness, and operational efficiency through continuous improvement initiatives and implementation of industry best practices.
• Monitor emerging regulatory requirements and industry trends and assess applicability to site validation and quality systems.
• Act as a mentor and technical resource for colleagues by sharing expertise, providing consultation and promoting a culture of compliance and quality excellence.
• Maintain current training requirements and remain…