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

Position Summary:

The Global Quality Operational Readiness (QOR) Sr. Quality Systems Specialist supports the implementation and operational readiness of Quality functions at new Biopharma manufacturing facilities (as well as new processes/faciltities at existing sites) across the EU, US, Canada, and other global locations. This role is instrumental in ensuring new sites meet global regulatory requirements and internal quality standards from the inception. The Global Quality QOR Sr. Quality Systems Specialist will work in the framework of cross-functional quality teams, including Subject Matter Experts (SMEs), and collaborate closely with Grifols BioPharma site's Engineering, Manufacturing, Regulatory Affairs, IT, and Global Quality to establish robust quality systems and processes aligned with cGMP and global health authority expectations. This position requires an individual who can operate effectively with limited supervision, independently progress deliverables in evolving project environments with changing business needs and priorities, and gain stakeholder alignment through influence, collaboration and credibility. Success in this role requires a demonstrated ability to quickly absorb new information, translate direction into action, proactively identify solutions, and effectively manage multiple priorities while maintaining strong stakeholder relationships.

Primary Responsibilities:

• Facilitate the transfer of knowledge and best practices from other established Grifols sites (Technology Transfer process). Focus will be on identifying and implementing best practices that are cGMP compliant, inspection-tested and successful, as well as efficient. These best practices will be contemporary with health authorities/regulatory agencies expectations.
• Collaborate with cross-functional teams (Engineering, Manufacturing, Regulatory Affairs, IT) to ensure quality is embedded in all aspects of site design and operations for new start up process.
• Translate strategic objectives and stakeholder requirements into practical deliverables, recommendations, and implementation plans with minimal management oversight.
• Execute assigned Operational Readiness deliverables with a high degree of independence, ownership, urgency, and accountability, progressing work forward using available information while appropriately escalating risk, barriers, and recommended solutions.
• Monitor project timelines, quality milestones, and risk mitigation plans for site readiness. Keep results (KPIs) visible to all stakeholders and to senior management on routine basis.
• Ensure readiness for regulatory inspections through comprehensive planning, mock audits, and gap assessments. Conduct practice sessions with key site personnel to have successful interactions with regualtory inspectors.
• Assist new start up site with review of validation master plans, sampling plans, master data setup, site master file development, product and raw material specifications, etc...
• Use expertise and sound judgement to make recommendations to site Quality and Global Quality regarding improvement opportunities.
• Assist BioPharma sites with recommendations for problem solving, mitigation of identified quality risks, and improvement of processes. Use quality risk-based approaches.
• Develop and maintain effective working relationships with stakeholders across Mnaufacturing, Quality, Validation, Engineering, Regulatory Affairs, and Global Quality through collaboration, active listening. and influence-based leadership.
• Monitor needed timelines and a sense of urgency with site Quality contacts so that the overall project milestones are not adversely impacted by quality support. In all cases, ensure competent quality oversight is established in the new site processes.
• Carry out visits to production plants to ensure compliance with regulations and quality standards. Perform walkthroughs in manufacturing, warehouse, other GMP areas to identify continuous improvement opportunities and partner with site management to get the improvements in place.
• Proactively identify quality related solutions and robust quality systems (as will be needed for day to day effective operations or during review by external regulators). Emphasze proactive problem-solving rather than reactionary responses. Ensure quality systems are mapped accordingly.

Additional Responsibilities:

• This position will work with individuals and teams of SMEs from within QOR and at the BioPharma sites to drive and monitor continous improvement and operational preparedness activities.
• May serve as manager delegate with demonstrated experience, as applicable.

Knowledge, Skills, and Abilities:

• Analytical Thinking: Capability to analyze data and metrics to inform decision-making and identify areas for improvement.
• Communication: Proven, successful communication skills to effectively convey quality standards and expectations to diverse stakeholders, including ability to clearly communicate technical and non-technical concepts, ask effective questoins, incorporate feedback, and adapt communication style to diverse stakeholder groups.
• Independent Execution and Ownership: Ability to independently execute assignments, maintain ownership of deliverables, and proactively advance work in dynamic environments.
• Risk Management: Proficiency in identifying, assessing, and mitigating risks associated with product quality and compliance.
• Problem-Solving: Ability to quickly identify quality issues and recommend effective solutions to maintain quality standards.
• Regulatory Knowledge Management: Demonstrated understanding of regulatory requirements (U.S. FDA, EMA, Health Canada, etc...).
• Collaboration: Ability to work collaboratively with other departments and external partners to drive alignment and ensure quality across the entire process.
• Project Management: Skills to monitor multiple quality initiatives and projects simultaneously, ensuring timely and successful completion. Reporting of progress on frequent basis to management.
• Learning Agility: Ability to rapidly absorb, retain, and apply new information, concepts, processes, and business requirements across multiple disciplines.

Requirements:

PhD in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 4 years relevant experience OR MS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 6 years relevant experience OR BS in a Life Sciences, Chemical Sciences, or relevant degree (STEM degree preferred: science, biotechnology/technology, engineering, math, or computer science) with a minimum of 7 years relevant experience OR an equivilant combination of education and experience.

Occupational Demands:

There is a requirement for travel for this position. It is expected to have 15% to 50% travel to the other Biopharma sites in scope of support by Qualtiy Operational Readiness. Some of this travel will be international travel. Work is performed in an office environment with exposure to electrical office equipment. Frequently sits for 6-8 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Occasionally walks and stands. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Frequently drives to site locations with occasional travel within the United States. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Interacts with others, relates sensitive information to diverse groups. Must work with diverse groups to obtain consensus on issues.

Location: NORTH AMERICA : USA : NC-Clayton:USNC0002 - Clayton