Sr. Quality Systems Specialist, Quality Operational Readiness (QOR)

Grifols•Clayton, NC

About The Position

The Global Quality Operational Readiness (QOR) Sr. Quality Systems Specialist supports implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities and new processes or facilities at existing sites across the EU, US, Canada, and other global locations. The role helps ensure new sites meet global regulatory requirements and internal quality standards from inception. Working with cross-functional quality teams and subject matter experts, the specialist collaborates with Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality to establish robust quality systems and processes aligned with cGMP and global health authority expectations. The position requires someone who can work effectively with limited supervision, progress deliverables independently in evolving project environments, and gain stakeholder alignment through influence, collaboration, and credibility. The specialist is expected to absorb new information quickly, translate direction into action, identify solutions proactively, manage multiple priorities, and maintain strong stakeholder relationships. The role involves travel to supported Biopharma sites, including international travel, and work in an office environment. Travel is expected to be 15% to 50%.

Requirements

PhD in Life Sciences, Chemical Sciences, or a relevant degree, preferably in a STEM field, and at least 4 years of relevant experience; or
Master’s degree in Life Sciences, Chemical Sciences, or a relevant degree, preferably in a STEM field, and at least 6 years of relevant experience; or
Bachelor’s degree in Life Sciences, Chemical Sciences, or a relevant degree, preferably in a STEM field, and at least 7 years of relevant experience; or an equivalent combination of education and experience.
Ability to analyze data and metrics to inform decisions and identify improvement areas.
Strong communication skills, including communicating technical and nontechnical concepts, asking effective questions, incorporating feedback, and adapting communication to diverse stakeholders.
Ability to execute assignments independently, maintain ownership of deliverables, and advance work in dynamic environments.
Proficiency in identifying, assessing, and mitigating product quality and compliance risks.
Ability to identify quality issues quickly and recommend effective solutions.
Demonstrated understanding of regulatory requirements, including U.S. FDA, EMA, and Health Canada requirements.
Ability to collaborate across departments and with external partners to drive alignment and quality.
Project management skills to monitor multiple initiatives and ensure timely completion, including frequent progress reporting to management.
Ability to rapidly absorb, retain, and apply new information, concepts, processes, and business requirements across disciplines.
Ability to communicate and understand information presented in spoken and written form, interact with others, handle sensitive information, and obtain consensus across diverse groups.
Ability to travel 15% to 50% to supported Biopharma sites, including internationally.

Responsibilities

Facilitate transfer of knowledge and best practices from established Grifols sites, focusing on cGMP-compliant, inspection-tested, efficient practices aligned with current health authority expectations.
Collaborate with Engineering, Manufacturing, Regulatory Affairs, and IT to embed quality in site design and operations for new start-up processes.
Translate strategic objectives and stakeholder requirements into practical deliverables, recommendations, and implementation plans with minimal management oversight.
Independently execute Operational Readiness deliverables with ownership, urgency, and accountability, and escalate risks, barriers, and recommended solutions appropriately.
Monitor project timelines, quality milestones, and risk-mitigation plans; keep KPI results visible to stakeholders and senior management.
Prepare for regulatory inspections through planning, mock audits, and gap assessments, and conduct practice sessions with site personnel.
Assist start-up sites with review of validation master plans, sampling plans, master data setup, site master files, and product and raw material specifications.
Recommend improvement opportunities to site Quality and Global Quality using sound judgment and expertise.
Support BioPharma sites with problem-solving recommendations, mitigation of quality risks, and process improvements using quality risk-based approaches.
Build effective working relationships across Manufacturing, Quality, Validation, Engineering, Regulatory Affairs, and Global Quality through collaboration, listening, and influence-based leadership.
Monitor timelines with site Quality contacts to help keep project milestones on track and ensure competent quality oversight in new site processes.
Visit production plants and conduct walkthroughs in manufacturing, warehouse, and other GMP areas to identify improvement opportunities and partner with site management to implement improvements.
Proactively identify quality solutions and robust quality systems for day-to-day operations and external regulatory review, emphasizing preventive problem-solving.
Ensure quality systems are mapped appropriately.
Work with QOR and BioPharma site subject matter experts to drive and monitor continuous improvement and operational preparedness activities.
May serve as a manager delegate when applicable and with demonstrated experience.