Grifols Shared Services North America, Inc Sr Manager QA New Product Development and System Validation 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.
The Sr. Manager manages their own activities related to their area of expertise. They schedule, oversee and evaluate the work of others related to new product development, design controls, and system validation projects. Recruits, interviews and makes hiring decisions for own department and may participate in hiring process for others. Key point of contact to ensure compliance with and demonstrate knowledge of site level policies related to area of expertise. Provides significant guidance to others regarding their area of expertise. This position is a Quality leader in providing guidance and strategic development for new products, performing systems verification and validation, and is the main Quality contact for providing guidance on any issue associated with the Procleix product lines.
Primary responsibilities for role:
● Leads the quality new product development and system validation team, ensures that quality engineering principles are applied to new product development and sustaining systems engineering projects for hardware, software and reagents.
●Oversee all quality aspects of the design control process: quality planning; verification and validation planning and execution; risk management; regulatory and compliance support.
●Independently performs complex tasks in support of their area of expertise including new product development, systems validation, design controls, as needed.
●Provides investigational support for Quality notifications, CAPAs, customer complaints and lead completion of system verification and validation activities for resolution.
●Ensures governing documents for their area of expertise are in accordance with existing regulations and company policies/standards.
●Cross-functional coordination with others as it relates to area of expertise.
●Interaction with regulatory and partner auditors/inspectors.
●Representation of QA interests on special, often complex, projects to support sustaining systems engineering projects.
●Serves as QA Approver (in EDMS) in workflows for documents related to area of responsibility, including documents associated with or generated from deviations/CAPAs, but which may be authored by other departments, such as MS&T, Manufacturing or QC.
●Area representative during health authority audits, partner audits and self-inspections.
●Manages direct reports, annual performance reviews, mentoring activities and scheduling the daily activities of the QA team members.
Knowledge, Skills, and Abilities:
● Ability to quickly and logically evaluate and solve complex problems on a daily basis, and guide others to do the same.
● Ability to clearly and concisely document results of complex projects, evaluations or investigations.
● Ability to develop project charters and timelines
Bachelor’s Degree, in life or physical sciences.
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.
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: 240611