Grifols Shared Services North America, Inc Director, Quality Assurance in Emeryville, 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.
To direct the day to day to day operations of the Grifols Diagnostic Solutions Quality Assurance units including Fermentation QA, Purification/Fill/Finished Product QA, Facilities/Utilities/Equipment QA, QA Validation, Shop Floor Quality and Development QA. Ensures that the QA organization coordinates with Manufacturing, Engineering, MS, Validation and Technology Development (TD) groups to investigate product quality issues. Direct the QA managers and associates to examine Quality processes that can be streamlined and improved.
Primary responsibilities for role:
Direct the day to day operation of the Fermentation QA, Purification/Fill/Finished Product QA, Facilities/Utilities Equipment QA, QA Validation, Shop Floor Quality and Development QA. Manage a staff of approximately 35 individuals responsible for Quality Assurance of all QA Production Process Units - Fermentation, Purification/Fill/Finished Product, Facilities/Utilities/Equipment. The Director QA will also oversee all QA Validation activities.
The Director QA will also be responsible for being the Single Point Of Contact/Subject Matter Ex-pert during all health authority (FDA, TUV) inspections
The Director QA will ensure that the QA team investigates production process unit deviations, ensuring that DRs and CAPAs are reviewed and closed on time. Ensure that the QA team establishes processes to trend significant Product Quality Indicator (PQI) data. Collaborate with Manufacturing, TD, Validation and Regulatory Affairs departments as necessary.
Owns the procedures that govern the Quality Assurance functions and ensures that all documents are approved and in alignment with the applicable Grifols Quality Standards
Address any product stability protocol or stability results deviations and escalate to Quality Head as appropriate
Ensure that the QA Production Process Unit teams conduct thorough investigations and product impact assessments in accordance with local procedures
Ensure that the QA staff are trained and that training records within Grifols Training Platform (GTP) are up to date
Ensure that internal trending reports and Product Quality Indicators (QPIs) are completed and reported on time in Site Quality Committee (SQC) and Management Review (MR) meetings
Coordinate with the Engineering group to ensure that equipment utilized at the site is calibrated and maintained per the required schedule
Coordinate with TD to ensure release testing methods are transferred per the approved SOP/protocols
Champions the continuous improvement of QA processes, defines process improvement/efficiency projects for QA
Select, train and develop staff so that they realize their full potential and work in conformance to company policies relating to environmental protection, health and safety at work.
Work with Site Environmental Health & Safety (EH&S) representatives to ensure that the Process QA organization adheres to Grifols EH&S standards, requirements and best practices while working in the plant.
Completion of PQI reports within the required times
Completion of Product Quality Impact Assessments and Investigation and closure of DRs and closure of CAPAs within the required time
QA Single Point Of Contact (SPOC) and Subject Matter Expert (SME) during FDA and other health authority inspections
The number of Product Quality related DRs defended to regulatory agencies during product review or site inspections.
The number and severity of GMP issues identified during internal and external audits related to Quality Assurance oversight of Fermentation QA, Purification/Fill/Finished Product QA, Facilities/Utilities/Equipment QA, QA Validation and Development QA units.
Efficiency of QA operations.
No safety incidents or HSE related observations
- Bachelor’s degree in Biochemistry, Molecular Biology, Immunology with 15 years or MS/PhD degree in science with 10 plus years.
At least 15 years experience in a regulated GMP testing laboratory with 10 years in a manager or higher-level position.
Experience with investigation of deviations and performing product impact assessments and product complaints
Strong scientific analytical and writing skills, proficient in MS Word, MS Powerpoint and MS Excel software
Must be familiar with GMP's and Quality System Regulations (QS Regs) and practical judgment in the interpretation and application of regulations and standards specific to Quality Assurance
Experience working with FDA licensed biologics and performing as Quality Single Point Of Contact (SPOC) and Subject Matter Expert (SME) during FDA inspections.
Must be able to think abstractly about data and be able to work with a team toward shared goals.
Must have good planning and organizing skills, manage time effectively by prioritizing tasks, taking the initiative to solve problems quickly, and knowing when to obtain assistance.
Individual must work in an ethical manner and ensure employees follow Grifols ethics and compliance guidelines.
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 2years of experience
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.
Req ID: 352528