To direct the day to day to day activities of the Grifols Diagnostic Solutions Manufacturing QA consisting of: QA Technical, QA Validation, QA Lot release. Ensures that his/her QA organization units coordinate with Manufacturing, Engineering, Validation and Manufacturing Sciences (MS) groups to investigate product quality issues and ensure Quality oversight for Validation. Direct the QA managers and associates to examine Quality processes that can be streamlined and improved.
This is a full time position located in San Diego, CA, reporting to the Director of Quality (Technical Director), Grifols Diagnostic Solutions.
Primary responsibilities for role:
- Direct the day to day activities of the Manufacturing QA – QA Technical, QA Validation and QA Lot release. Manage a staff of approximately fifteen (15) individualsresponsible for the designated QA functions. The individual will also beresponsible for being the Single Point Of Contact/Subject Matter Expert during all health authority (FDA, TUV)inspections for Manufacturing QA, ensuring that his/her QA team(s)investigates production non-conformities/deviations, ensuring that NCRs/DRs and CAPAs are reviewed and closed on time. Collaborate with Manufacturing,MS, 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
- Ensure that his/her QA teams conduct thorough investigations and product impact assessments in accordance with local procedures
- Cross-functional coordination with other Quality teams for deviations impacting multiple areas
- Ensures that his/her QA Validation staff reviews/approves validation documents that are in alignment with site validation master plans and procedures
- Ensure that his/her 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 (PQIs) 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 requiredschedule
- Coordinate with Engineering to assess changes to Facilities, Utilities and Equipment
- Coordinate with MS 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,
- Champions the risk assessement of Production and QA processes
- 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.
Key Performance Indicators / Measures for Success:
- Completion of PQI reports within the required times
- Completion of Product Quality Impact Assessments and Investigation and closure of NCRs/DRs and closure of CAPAs within the required time within his/her QA units
- QA Single Point Of Contact (SPOC) and Subject Matter Expert (SME) during FDA and other health authority inspections for matters related to QA Technical, QA Validation, QA Lot release
- The number of QA Validation/CPV and Facilities/Utilities/Equipment 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 QA Validation, CPV and Facilities/Utilities/Equipment QA.
- Efficiency of QA operations.
- No safety incidents or HSE related observations.
Bachelor’s degree in Biochemistry, Molecular Biology, Immunology or related science or MS/PhD degree in science related science or appropriate education and experience in Medical Device, IVD or biological/pharmaceutical manufacturing field
- At least 10 years experience in a regulated GMP/ISO/QSR environment (biotechnology, blood banking, diagnostics, medical device or biopharmaceutical industries) and a minimum of 7 years management experience
- Experience with Process, Cleaning, Facilities/Utilities/Equipment and Analytical Method Validation
- Experience with technical 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 for matters related to Technical QA, QA Validation.
- 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.
- Must meet the six (6) mission critical competencies listed below