Senior Quality Associate I/II, QA General Computer Systems

About the role

Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

The Senior Quality Associate provides Quality Assurance oversight for GxP computerized systems throughout the system lifecycle, including validation, data integrity governance, regulatory compliance, computerized system administration oversight, and ongoing lifecycle management activities. These systems may include process control systems, analytical software, laboratory informatics systems, manufacturing systems, infrastructure applications, and other regulated computerized systems. This role serves as a technical Quality subject matter expert for validated computerized systems, including process control systems, analytical software, laboratory informatics applications, and other GxP-regulated technologies. The incumbent provides Quality oversight for computer system lifecycle activities, validation, data integrity, electronic records and signatures compliance, and applicable regulatory expectations.

Key Responsibilities

• Serve as the Quality subject matter expert and consultant for validation and lifecycle management of GxP computerized systems supporting site operations.
• Partner with system owners, project teams, and business customers to ensure validation deliverables are planned, developed, reviewed, and completed throughout the system lifecycle.
• Support the cGMP/CSI process by maintaining accurate system inventory records and working with system owners to complete required documentation.
• Provide Quality oversight to ensure computerized systems are designed, configured, maintained, administered, trained, and validated in accordance with approved procedures, data integrity principles, cybersecurity requirements, and applicable regulatory expectations including 21 CFR Part 11.
• Provide independent Quality Assurance oversight of computer system administration activities, including user access management, role and permission assignment, periodic access reviews, system configuration activities, and verification that administrative controls are executed in accordance with approved procedures, data integrity requirements, and applicable regulatory expectations.
• Ensure computerized system backup, recovery, and business continuity requirements are defined, implemented, monitored, and documented, including routine verification activities and escalation of identified issues.
• Support FDA inspections, internal and external audits, regulatory commitments, and inspection readiness activities related to computer system validation and Quality computer systems.
• Lead or support data integrity governance activities for computerized systems, including Data Integrity Risk Assessments, remediation activities, periodic reviews, audit trail oversight, and alignment with MHRA guidance, FDA expectations, 21 CFR Part 11, EU Annex 11, and EU Annex 15 requirements.
• Review and support Change Control requests associated with GxP computerized systems and supporting infrastructure.
• Provide Quality consulting and timely review and approval of validation deliverables supporting new computerized systems, system enhancements, upgrades, integrations, infrastructure changes, and business initiatives.
• Independently make sound, risk-based Quality decisions and clearly communicate the rationale for those decisions.
• Influence cross-functional decision makers and provide Quality guidance to ensure compliant and practical outcomes.

Additional Responsibilities

• Perform additional Quality Assurance duties based on the assigned business unit and operational needs, which may include serving in advanced Quality system roles such as author, reviewer, approver, administrator, or coordinator for processes including Change Control, Quality Notifications and CAPAs.
• Provide Quality input for validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and regulatory submissions.
• Represent Quality management in business unit meetings, project meetings, and other cross-functional forums as assigned.

Qualifications

Senior Quality Associate II: BA/BS degree in a STEM discipline, including Science, Technology, Engineering, or Mathematics, with a minimum of 6 years of relevant experience. A minimum BA/BS degree is required. Depending on the area of assignment, directly related experience, a combination of directly related education and experience, and/or demonstrated competencies may be considered in place of the stated requirements.

Senior Quality Associate I: BA/BS degree in a STEM discipline, including Science, Technology, Engineering, or Mathematics, with a minimum of 4 years of relevant experience. A minimum BA/BS degree is required. Depending on the area of assignment, directly related experience, a combination of directly related education and experience, and/or demonstrated competencies may be considered in place of the stated requirements.

Knowledge, Skills, and Abilities

• Excellent written and verbal communication skills.
• Working knowledge of domestic regulatory requirements, including FDA expectations, and applicable international regulatory agency requirements and guidelines.
• Ability to work independently, manage competing priorities, collaborate effectively with cross-functional teams, and apply sound judgment in a regulated GxP environment.

Work Environment & Physical Requirements

• Work is performed in office, laboratory, manufacturing, and/or warehouse environments.
• May include exposure to biological fluids with potential exposure to infectious organisms; occasional exposure to extreme cold below 32°F in production areas; and exposure to electrical office and laboratory equipment.
• Personal protective equipment may be required, including protective eyewear, garments, and gloves.
• Work may be performed while sitting or standing for 2–4 hours per day.
• May require light to moderate lifting and carrying, with a maximum lift of 35 pounds.
• May occasionally walk, bend, twist the neck and waist, reach above or below shoulder height, and perform frequent foot movements.
• Must be able to communicate complex information and ideas clearly so others can understand, listen to and understand information presented through spoken and written words and sentences, and perform tasks by following written or oral instructions and procedures.