QA Manager

QA Manager I – Tri-Valley Career Center

As a QA Manager I, you will oversee 5–8 direct reports and lead the Quality Assurance function for instrument and regulated consumable manufacturing, service, and support operations. You will implement and maintain quality system processes, ensure regulatory compliance (ISO 13485 and FDA GMP), and provide quality oversight. Strong leadership, communication, critical thinking, and organizational skills are required. You will manage a high‑performing, flexible team in a matrix environment, translating the company’s quality strategy into SOPs and procedures to meet global standards across Northern California sites.

The role includes developing and executing both short‑term and long‑term strategies to improve and streamline quality processes.

• Ensure compliance & readiness across all Northern California sites, maintaining continuous compliance and inspection readiness.
• Analyze and present data to senior management to confirm resource adequacy and prioritize projects.
• Use data-driven insights to evaluate the effectiveness of Quality Operations processes and identify opportunities for improvement.
• Guide site teams on appropriate actions to address product performance issues and maintain quality standards.
• Evaluate and authorize product and process changes to ensure conformity with specifications and regulatory requirements.
• Oversee QA operations to uphold GMP, ISO, and regulatory standards.
• Collaborate with production teams to resolve quality issues, implement corrective actions, and drive continuous improvement.
• Ensure timely review and approval of batch records, SOPs, and quality documentation.
• Provide training and guidance to cross-functional teams, promoting proactive quality practices.
• Serve as the QA liaison for Northern California operations, aligning with corporate standards and supporting audits and inspections.
• Supervise daily operations, including team workload distribution, employee development, and training.
• Develop and improve Quality Management System (QMS) procedures and training materials.
• Support audits, inspections, and other quality and compliance activities.
• Make timely, effective decisions in a fast‑paced, sometimes stressful environment, while promoting a quality-driven culture.

• Bachelor’s degree in Life Sciences, Engineering, or a related field.
• Minimum 5 years of experience in quality systems, including supervisory responsibilities.
• Experience as a GMP and/or ISO trainer is highly desirable.
• Experience working in a global organization or with multiple manufacturing sites is a plus.
• Certifications such as Quality Engineer, Quality Manager, Six Sigma Green Belt or Black Belt are preferred.
• Strong knowledge of ISO 13485, GMP, and other regulatory requirements.
• Proven experience in audit planning and execution.
• Excellent communication and leadership skills.

• Competitive medical plans, free HSA funds, fertility stipend, group life and disability insurance, paid parental leave.
• 401(k) plus profit sharing, employee stock purchase program, upgraded mental health platform.
• Extensive learning and development opportunities, education benefits, student debt relief program, pet insurance, wellness challenges.
• Paid time off, Employee Resource Groups (ERGs), and more.

The estimated base salary range for this position is $105,000 to $144,500 at the time of posting. Actual compensation will be provided in writing at the time of offer, and may be adjusted based on geographic location, experience, and other factors. This position is eligible for a variable annual bonus, dependent upon achievement of individual objectives and company performance.

Mid‑Senior level

Full‑time

Quality Assurance

Professional Training and Coaching

Bio‑Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.