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

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? 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.

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.  May serve as manager delegate with demonstrated experience, as applicable.

 

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.                         
• 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.                            
• 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.

 

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
• 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