Associate Director, QA Complaints

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.

Grifols Diagnostic Solutions is seeking an Associate Director, QA Complaints to be part of our Quality Assurance team in San Diego, CA. The Associate Director, QA Complaints manages the Complaints Handling, Post Market Surveillance, and Vigilance process for Grifols Diagnostic Solutions for one or more product lines.  This position is a Quality leader responsible for providing guidance and strategic management for customer complaints, implementation of effective corrective actions, and post market performance of one or more products.  Additionally, this position is responsible for hiring, training, coaching, and mentoring members of the QA Complaints team.

We are seeking individuals with at least 10 years of related technical experience in Quality Assurance complaint handling with a bachelors degree in Life Sciences. Individuals must have prior supervisory or management experience. 

Primary responsibilities for role: 

• Leads a team of Quality Complaints Specialists including hiring, training, coaching, and other management responsibilities. Serves as a mentor and example for the team to ensure policies and procedures are appropriately applied. Responsible for shaping and maintaining a positive, supportive, and effective work environment by aligning leadership practices with organizational values and goals. 
• Leads effective complaint management by ensuring appropriate complaint investigations are conducted and effective trending is utilized to ensure safety and effectiveness of Grifols products.      
• Leads effective management of logistics and product transport related complaints.
• Assign tasks to team members to achieve effective root cause analysis, on-time closure improvements in complaint management. Assign tasks to team members to achieve effective management and monitoring of complaints trending and metrics.
• Trends data and monitors trends for possible systemic issues that may be impacting one or more products and assigns appropriate corrective actions internal and external stakeholders to mitigate issues. 
• Reviews recommended CAPAs, as part of complaint closure process, and determines their appropriateness for the Root Cause(s) that were identified.
• Performs final QA Approval for Complaints Records, Post Market Surveillance and Medical Vigilance reports for one or more products.
• Provides strategic direction with all external partners and 3rd party developers regarding instruments, HW and SW complaints, and Post Market processes. 
• Assign tasks to team members to ensure appropriate issue escalation occurs related to any quality or compliance issues.
• Responsible for oversight of inspectors during Health Authority audits/inspections, as necessary.  Serves as the escort for the Heath Authority as required.
• Provides support in other QA functions as needed.
• Collaborates with Regional Quality Representatives to ensure efficient and effective quality system execution as they relate to Procleix products.
• Leads the department in setting strategic objectives, deliverables and metrics for the customer complaints handling process. 

Knowledge, Skills, and Abilities  

• Knowledge of quality systems that ensure control of manufacturing processes in accordance with cGMP.
• Knowledge of FDA and EU regulations, ISO requirements.
• Skill in the use of computer systems for data compilation, managements, and analysis.
• Experience with project management (problem solving and resolution) and general business principles. 
• Excellent written and interpersonal communication skills as well as strategic and conceptual thinking.
• Experience with leading team.
• Presentation and meeting organizat