Quality DirectorReq # JR - 022250 Location Hayward, California, United States Job Category Quality Control Date posted 06/10/2020
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Site Quality Director (QMR)
Responsible for Quality Assurance and Quality Control for the site. Guarantee the quality of services and products according to Baxter Procedures and Regulatory requirements. Achieve quality targets and systemic improvement projects.
Main Activities and Responsibilities:
- Drive and Cultivate a culture of Quality and Compliance.
- Establishes strategy for ensuring Quality Management Systems are implemented and maintained in accordance with applicable Baxter Global Quality guidelines, procedures, and strategy as well as external regulatory agency requirements.
- Set strategic direction for quality within that area, maintaining quality oversight and assurance of appropriate standards, and driving continuous improvement.
- Responsible for QA review, approval, and Quality operational oversight of internal manufacturing documentation, defining and agreeing on the follow up of corrective and preventative actions from changes and deviations during manufacture.
- Be responsible for the delivery of QA activities for their assigned portfolio of projects. Accountable for aligning all QA activities across a project and empowered to resolve any project quality issues across the QA sections.
- Partner with Business to plan and execute product launches, bringing visibility of Quality requirements, costs, timelines and investments needed.
- Support a strong lean culture that promotes standardization, simplification and continuous improvement.
- Preparation of Executive summaries as required;
- Responsible for planning and execute any Remediation or implementation of new GQP or Regulations.
- Accountable for Budget and CAPEX within Quality Organization and related KPIs.
- B.S. in Chemistry, Microbiology, or Pharmacy (or related)
- Quality Assurance, Pharmacy Quality Systems, Management Experience
- Min. 10 years within Quality Systems, 5 years in a Quality Management Position within a healthcare (regulated) environment
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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