A Snapshot of Your Day as Quality Supervisor As a Quality Supervisor, your day is defined by a balance of strategic leadership and technical rigor, serving as the primary guardian of our product integrity and regulatory excellence. You will provide essential direction to the quality control team, fostering an environment where high performance meets uncompromising standards. Much of your time will be dedicated to developing and implementing sophisticated programs for testing and trend analysis, ensuring that every facet of our operation remains in strict alignment with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP).

Whether you are spearheading ISO initiatives or driving facility-wide quality goals, your expertise ensures that our compliance framework is both robust and forward-thinking. You will spend your day planning staff strategies to guarantee that testing and releases are completed on schedule, taking personal responsibility for the evaluation and release of highly regulated, critical products. As a pillar of our Quality Management System (QMS), you will actively manage and provide vital inputs for core processes including design control, risk management, and corrective actions.

You serve as a key advisor to Management, translating complex process data into clear, actionable insights. By providing the rationale behind critical decisions—always prioritizing regulatory compliance—you ensure that our leadership team is fully informed and that our commitment to quality remains our competitive advantage.

Strategic Leadership: Lead and develop a high-performing QA specialist team, ensuring technical competency and resource allocation are aligned with both regulatory requirements and operational priorities.

Regulatory & Sanitary Alignment: Act as a vital link to the Responsible Sanitary , ensuring all data-driven decisions, cold chain compliance,



and stability programs are fully aligned and transparently communicated. Optimize quality control systems and continuous improvement initiatives to enhance process efficiency and commercial impact without disrupting business continuity.

Quality System Oversight: Manage the full lifecycle of quality processes, from reviewing engineering designs and change requests to overseeing IQ/OQ/PQ validation plans and maintaining the validated state.

Risk & Issue Resolution: Lead critical investigations and corrective actions (CAPA), ensuring rapid closure of quality issues and the precise execution of ship holds, FSCAs, or recalls.

Provide

Management and the Responsible Sanitary with continuous, trend-based reporting to enable informed, joint decision-making and full visibility of process health.

Audit Readiness & Training: Drive a culture of compliance by coordinating cGMP/ISO training and leading internal and external audits to ensure the facility remains inspection-ready at all times. A Bachelor’s degree (BA/BS) or equivalent in a science, engineering, or a related technical field.

Proven Leadership: 5+ years of relevant experience in Quality Systems, including a strong track record in a supervisory or people-management role.

Risk Management Mastery: A solid understanding of risk management regulations and the ability to apply these principles to complex operational challenges.

Training Excellence: Proven experience acting as a GMP and/or ISO trainer , with the ability to build technical competencies and foster a culture of compliance across the team.

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a general leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products.

📌 Head of Quality Assurance (Cuautitlán Izcalli)
🏢 Bio-Rad LAM
📍 Cuautitlán Izcalli