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Grifols Shared Services North America, Inc Sr. Manager, QC - Immunohematology Laboratory in San Diego, California

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Senior Manager, QC - Immunohematology

Summary:

The Senior 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 Senior 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 Senior 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

  • Adoption Assistance

  • Employee assistance plan

About you:

Knowledge, Skills, and Abilities we are looking for

  • Advanced practical and technical knowledge of immunohematology procedures

  • Advanced knowledge of general laboratory procedures, laboratory safety, and GMP record keeping

  • Knowledge of Good Manufacturing Practices (cGMP) and experience in working in an FDA regulated environment.

  • Adaptability, ability to be flexible in a constantly changing manufacturing environment.

  • Proven competency in logic driven problem-solving skills

  • Excellent communication, presentation, and collaboration skills

  • Strong planning and organizational skills.

  • Proficiency using an EDMS and ERP system

  • Strong knowledge of Quality monitoring methods, KPI's and SPC tools and methodology

  • Immunohematology Subject Matter Expert for internal, third-party, and regulatory audits

  • Advanced statistical analysis, root cause analysis, and report writing skills

Education and Experience we require for this role

  • Typically requires a Bachelor’s in a Biological Science with SBB(ASCP) certification or Master's degree in Immunohematology, Transfusion Medicine, or related field which is highly preferred

  • 10+ years of work experience with a Bachelor’s degree or 8+ years if you have a Master's degree

  • 6+ years of experience in a supervisory role in a GMP environment with a Bachelor’s degree or 4+ years if you have a Master’s degree

  • Experience in a CLIA environment is highly preferred.

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 10 years of experience, an equivalency could include 8 years of experience with a Master’s degree and 6 years of experience with a Ph.D.

Occupational Demands

Work is performed in both a lab and an office environment. Frequently sits for 4-6 hours per day. Occasionally walks. Occasionally bends and twists neck. Light to moderate lifting and carrying objects with a maximum lift of 25lbs. Some occasional travel within the United States. Able to communicate complex information and ideas so others will understand; ability to listen and understand instruction. Ability to apply abstract principles to solve complex conceptual issues.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Req ID: 492747

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