Senior Quality Operations Specialist

Curia • Albuquerque, NM

8d • Onsite

About The Position

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.

Requirements

• 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
• 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.
• Ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations.
• Strong written and verbal communication skills, along with effective presentation skills.
• Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages.
• Strong grasp of algebraic and geometric principles.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions.
• Adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.
• Recognized subject matter expert in quality systems, validation lifecycle management, qualification, commissioning, and regulatory compliance.
• Demonstrates sound judgment and the ability to make independent, risk-based quality decisions in a regulated cGMP environment
• Strong knowledge of current FDA, EMA, ICH, and other applicable regulatory requirements and industry best practices related to pharmaceutical and biologics manufacturing.
• Ability to evaluate complex technical and compliance issues and provide practical, compliant solutions that support business objectives while maintaining product quality and patient safety.
• Excellent written, verbal, and presentation skills with the ability to communicate effectively across all levels of the organization and with external customers, auditors and regulatory agencies.
• 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.
• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Nice To Haves

• 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

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 knowledgeable of applicable regulations, guidance documents, and company procedures.
• Perform other duties as assigned

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior