Manager, Quality Control - Immunohematology Laboratory / Production Process

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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.

Manager, QC - Immunohematology

 

Summary:

The Manager, Quality Control will be a hands-on, technical, leadership role responsible for the direct day to day operations of the Immunohematology QC laboratory for Reagent Red Blood Cells (RRBC) which are part of our blood group typing product portfolio. This individual will have the unique opportunity of building this a QC laboratory and production process at our San Diego Campus from scratch with a fantastic, collaborative group of individuals. This role is also responsible for the Immunohematology Stability Program, including all on-going annual monitoring stability, shelf-life stability as required, procedures, and processes. Advanced knowledge of immunohematology procedures and work experience in a regulated (GMP) industry is required to be able to fulfill the role as well as knowledge in laboratory safety and procedures. The QC Manager will work with Manufacturing Technical Support, Validation, Manufacturing Science, and Quality Assurance groups to ensure product performance, operational efficiency, and laboratory maintenance. This position reports directly to the Director of Quality Control. The Sr. Manager of Quality Control,  especially at the beginning, will require occasional domestic and international travels for training  at other facilities and exchanging knowledge with other professionals in our company.

 

Why Grifols:

Our sustainable growth strategy allows this role to work in a startup-like environment, but with the stability of a multinational, global acting company. The Manager is a decision maker & creator, will build this QC laboratory and product line with us and is given the opportunity for growth within our organization. The work environment is characterized by an open leadership style and an open and supportive culture.

 

Your primary responsibilities:

• You develop strategic project plans, collaborate with stakeholders, manage the project execution and laboratory budget allocation
• You are responsible for the transfer of QC methods from planning to execution, and through the implementation of the transfer
• You are the product knowledge expert with excellent technical knowledge of blood typing science and you share your product knowledge with QC Lab Analysts and other stakeholders to enhance their expertise
• You facilitate the adoption of new procedures by developing, writing, and implementing standard operating procedures (SOPs)
• You develop the equipment, assay and process validation protocols and you identifying critical control points; you will also manage the execution of validation protocols and monitor implementation
• You collaborate with subject matter experts to define QC processes
• You develop IHT specific training requirements to support the QC training program
• You are responsible for monitoring Analysts performance against expectations as well as for QC key performance indicators for the Immunohematology Lab
• You represent QC during audits (internal, external, 3rd party), and FDA inspections
• You resolve deviations, perform investigations, root-cause analysis, and trouble-shoots product, assay, or equipment failures
• You will lead a team of Quality Control Analysts in the future which includes performance management, development, and staffing allocation
• You maintain technical competencies, perform benchwork as required, and participate in continuing education events such as management and technical training

 

More about us, benefits we provide you

• salary in line with the market as well as an annual bonus target
• flexible working hours, 80% on site and 20% remote
• free parking
• Professional development opportunities (training, career development)
• Gym pass, Employees perks program
• 401 (K) Retirement Plan (Grifols will match 100% on the first 4% of eligible compensation you contribute, and 50% on the next 2% of eligible compensation you contribute)
• Health insurance: Medical, Dental, Vision
• Travel accident insurance, Life and AD and D Insurance
• Short- & Long-Term Disability Insurance
• Health Savings Account, Flexible Spending Account
• Critical Illness, Accident, Hospital Indemnity coverages