Grifols Shared Services North America, Inc Senior Manager, Quality Assurance in Emeryville, California
The Sr. Manager will manage their own activities related to their area of expertise. They will schedule, oversee and evaluate the work of others. Key point of contact to ensure compliance with and demonstrate knowledge of site level policies.
Primary responsibilities for role:
Ensures governing documents for their area of expertise are in accordance with HA regulations and company policies/standards.
Cross-functional coordination with others as it relates to area of expertise.
Provide direct support for all regulatory Health Authority inspections, responses and follow-up actions.
Representation of QA interests on special, often complex, projects related to area of expertise within the global organization. May lead project teams.
Manages operations within departmental budget.
May make decisions that have high potential to impact company finances and reputation
Manage the Self-Inspection program for the site including audit execution, audit reports, schedule, CAPA responses, follow-up, audit closure, CAPA databases and track Self Inspection Key Performance Indicators
Manage (drive timely closure, act as QA Approver) all non-deviation sourced CAPAs (audit CAPAs, continuous improvement CAPAs, gap assessment CAPAs) and report associated KPIs.
Manage the Document Control and Records programs including EDMS Administration, Logbooks, Records archival, and associated program audits.
Manage direct reports (Document Control and Records). Performs annual performance reviews, mentoring activities and scheduling the daily activities of department staff.
Collect and analyze site Quality metrics for Site Quality Committee to determine state of Site Compliance.
Oversees the Standards review process and chairs the Standards Committee.
Provide guidance in remediating compliance deficiencies.
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.
- Minimum of 10 years in a regulated (GMP/ISO/QSR) industry and minimum of 6 years supervisory experience. QA experience a must.
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.
- May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.
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: 213527