Associate Director, QA Complaints

Company: Grifols, S.A
Location: San Diego
Posted on: May 18, 2025

Job Description:

Select how often (in days) to receive an alert: Create AlertWould 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 health and well-being worldwide. We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries.Grifols Diagnostic Solutions is seeking an Associate Director, QA Complaints to join our Quality Assurance team in San Diego, CA. This role manages the Complaints Handling, Post Market Surveillance, and Vigilance processes for one or more product lines. It is a leadership position responsible for guiding customer complaints, implementing corrective actions, and overseeing post-market performance. The role also involves hiring, training, coaching, and mentoring the QA Complaints team.We seek candidates with at least 10 years of technical experience in Quality Assurance complaint handling, a bachelor's degree in Life Sciences, and prior supervisory or management experience.Primary responsibilities include:

• Leading the QA Complaints team, including hiring, training, coaching, and management, ensuring policy adherence and fostering a positive work environment.
• Managing complaint investigations and trending to ensure product safety and effectiveness.
• Handling logistics and transport-related complaints.
• Assigning tasks for root cause analysis and complaint metrics monitoring.
• Analyzing data for systemic issues and implementing corrective actions.
• Reviewing CAPAs and ensuring their appropriateness.
• Final QA approval for complaints records and reports.
• Providing strategic direction for external partners regarding complaints and post-market processes.
• Overseeing inspections and audits, serving as the escort as needed.
• Supporting other QA functions as required.
• Collaborating with regional quality teams for efficient process execution.
• Setting strategic objectives and metrics for complaint handling.Knowledge, Skills, and Abilities:

• Understanding of quality systems and cGMP compliance.
• Knowledge of FDA, EU regulations, and ISO standards.
• Proficiency in data management and analysis tools.
• Project management skills.
• Excellent communication and leadership skills.
• Ability to multitask and negotiate conflicts.Education: Bachelor's degree in life or physical sciences, with experience in clinical labs, diagnostics, or related fields.Experience: Minimum 10 years in QA, complaint handling, or pharmaceutical manufacturing, with at least 5 years in a supervisory role.Additional Information: Experience or education equivalency may be considered. Work involves office environment, occasional bio-risk area entry, and travel within the US. Physical demands include sitting, walking, lifting, and communication skills.Pay Scale: Estimated $160,264 to $200,330 annually, with bonus eligibility and benefits such as health insurance, PTO, 401(k), and tuition reimbursement. Final compensation depends on various factors.Grifols values diversity and equal opportunity employment, adhering to applicable laws and ordinances.
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Keywords: Grifols, S.A, Lake Forest , Associate Director, QA Complaints, Executive , San Diego, California