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 organization/ facilitation skills required.
• Ability to express view and opinions clearly, listen well, and accept conflicting points of view.
• Team player and ability to multi-task.
• Excellent analytical, organizational skills with a demonstrated ability to negotiate and resolve conflicts

Education        

Bachelor’s degree, in life or physical sciences, with experience in a clinical laboratory, diagnostic quality or technical area.   

Experience

• At least 10 years related technical experience with significant QA, complaint handling, and/or pharmaceutical manufacturing.
• Minimum of 5 years of supervisory / managerial experience

Equivalency     

Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements.  Example:  If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.        

Occupational Demands 

Work is performed in an office environment with exposure to electrical office equipment. May occasionally enter BioRisk Area.   Exposure to biological fluids with potential exposure to infectious organisms. Personal protective equipment required such as protective eyewear, garments and gloves. 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. Drives: varies may or may be required to 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.

Pay Scale

The estimated pay scale for the Associate Director, Quality Assurance Complaints role based in San Diego, CA, is $160,264 to $200,330 per year. Additionally, the position is eligible to participate in up to 15% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg 

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