Job Description

Senior Quality Operations Specialist in Albuquerque, NM

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

Education and Experience:

• Bachelor's degree (BS or BA) in Chemistry, Biology, Microbiology, Engineering, Pharmaceutical Sciencesor a related scientific discipline from a four-year accreddited 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.
• 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

Supervisory Responsibilities:

This role does not have direct supervisory responsibilities. As a senior individual contributor, the Senior Quality Operations Specialist:

• Provides technical guidance and mentorship to quality, validation, engineering and operational personnel on validation lifecycle activities, quality systems and regulatory expectations.
• Serves as the Quality representative and independent quality approver for validation and qualification activities, ensuring quality and compliance requirements are appropriately applied and maintained.
• Leads cross-functional discussions related to validation strategy, risk assessments, compliance decisions, and quality system requirements.
• Influences project teams and stakeholders to ensure quality and compliance considerations are integrated into facility, equipment, process and computerized system lifecycle activities.
• Shares knowledge, best practicesand regulatory expectations to support the development of colleagues and promote a culture of quality, compliance and continuous improvement.

Language Skills:

The ideal candidate should have the ability to read and interpret various documents, such as safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, they should possess strong written and verbal communication skills, along with effective presentation skills.

Mathematical Skills:

Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.

Reasoning Ability:

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.

Computer Skills:

The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.

Other Skills and Abilities:

• 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.

Other Qualifications:

Must pass a background check

Must pass a drug screen

May be required to pass Occupational Health Screening

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.

The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.

The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.

The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may occasionally be exposed to moving mechanical parts, elevated heights, airborne particles, electrical activities and vibration. In addition, some positions may work with or be exposed to, compressed gases and must wear ea