Senior Quality Operations Specialist

About the role

The Senior Quality Operations Specialist plays a critical role in ensuring that all activities within the Quality organization comply with cGMP regulations, regulatory expectations, and company quality systems. This role serves as the Quality Assurance subject matter expert and quality approver for validation, qualification, engineering, facilities, utilities, computerized systems, and manufacturing-related activities.

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.
• Maintain current training requirements and remain knowledgeable of applicable regulations, guidance documents, and company procedures.
• Perform other duties as assigned.

Requirements

Minimum of eight (8) years of progressive experience in the pharmaceutical, biologics, biotechnology, or related regulated industry, with significant experience in Quality Assurance, Validation activities, Engineering Quality, Manufacturing Quality or Regulatory Compliance.

• Demonstrated experience providing Quality Assurance oversight and approval of validation lifecycle activities, including equipment qualification, facility and utility qualification, process validation, cleaning validation, computerized systems validation and commissioning activities.
• Demonstrated experience reviewing and approving quality system records, including validation protocols and reports, change controls, deviations, CAPAs, risk assessments and controlled GMP documentation.
• Strong working knowledge of current cGMP regulations, industry guidance and regulatory expectations associated with pharmaceutical and/or biologics manufacturing operations.
• Experience supporting facility expansions, capital projects, technology transfers, equipment implementation, and manufacturing process improvements within a regulated environment.
• Demonstrated ability to apply risk-based decision making, interpret regulatory requirements and provide independent quality guidance to cross-functional teams.
• Experience supporting customer audits, regulatory inspections and responses to compliance observations is preferred.
• Experience in aseptic manufacturing, biologics manufacturing and/or contract development and manufacturing (CDMO) environments is strongly preferred.

Qualifications

• Bachelor's degree (BS or BA) in Chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciences or a related scientific discipline from a four-year accredited college or university.
• Recognized subject matter expert in quality systems, validation lifecycle management, qualification, commissioning, and regulatory compliance.
• Strong knowledge of current FDA, EMA, ICH, and other applicable regulatory requirements and industry best practices related to pharmaceutical and biologics manufacturing.
• Proven ability to influence cross-functional teams and drive alignment on quality and compliance requirements without direct supervisory authority.
• Demonstrated ability to lead and participate in complex projects, prioritize competing demands and deliver high-quality results in a fast-paced environment.
• Skilled in investigation techniques, root cause analysis, quality risk management and continuous improvement methodologies.
• Provides technical mentorship and consultation to colleagues and project teams to support compliance, quality system effectiveness and professional development.
• Maintains a high level of attention to detail, technical accuracy, and data integrity in all aspects of work.
• Demonstrates leadership through expertise, collaboration, accountability and a commitment to quality excellence.
• Promotes a safe and healthy work environment by adhering to established safety practices, identifying potential hazards, and supporting a culture of safety and compliance.