Director of Critical Environmental Programs (GxP): Fremont, CA (60925)

The Director of Critical Environment Programs (GxP) is responsible for the regional oversight, implementation, and continuous improvement of Critical Environment Cleaning Programs supporting regulated, controlled, and high-compliance facilities. This role serves as the company's subject matter expert for cleaning within GMP/GxP environments and ensures adherence to all site-specific, regulatory, and quality standard operating procedures.

Working closely with operations leadership, unit managers, clients, and Corporate Quality teams, this position drives compliance, audit readiness, training, and standardized program execution across the region. The Director provides technical guidance, supports mobilizations, and partners with customers to maintain contamination control and regulatory expectations in critical environments.

Responsibilities

• Lead and govern the Critical Environment Cleaning Program across the region to ensure consistent, compliant execution.
• Serve as the technical subject matter expert (SME) for GMP/GxP and other controlled environment cleaning standards.
• Establish and maintain a regional audit program to monitor cleaning compliance, documentation practices, and SOP adherence.
• Support client audits, regulatory inspections, and qualification processes as needed.
• Partner with operations teams and clients to develop customized cleaning solutions for regulated and quality-controlled spaces.
• Support Root Cause Analysis (RCA) and Corrective and Preventive Action (CAPA) processes related to cleaning non-conformities.
• Coordinate with Corporate Quality Assurance on GxP initiatives, updates, and program enhancements.
• Develop and deliver training for new and existing associates on GMP cleaning SOPs, cleanroom behavior, and contamination control practices.
• Incorporate industry best practices and evolving regulatory expectations into program standards and procedures.
• Support regional mobilization of Critical Environment Cleaning programs for new or transitioning accounts.
• Develop standardized client-facing materials and contribute to Monthly and Quarterly Business Reviews (MBR/QBR).
• Evaluate existing critical environment programs, make improvement recommendations, and guide implementation of revised systems or procedures.
• Ensure program compliance with company Health, Safety, Security, and Environmental requirements and all authorities having jurisdiction.
• Utilize company systems and technology tools accurately for reporting, communication, and program management.
• Prepare and maintain required reports, records, and documentation.
• Other tasks and projects consistent with the role as requested by leadership.

Qualifications

• Extensive experience in GMP/GxP, cleanroom, pharmaceutical, biotech, medical device, or other regulated critical environments.
• Strong knowledge of contamination control principles, cleanroom behavior, and critical environment cleaning methodologies.
• Experience supporting audits, inspections, and compliance programs.
• Demonstrated leadership and ability to influence cross-functional operations teams.
• Strong written and verbal communication skills, including client-facing presentations.
• Ability to multitask, prioritize, and operate effectively in dynamic environments.
• Analytical and problem-solving capability with a structured approach to compliance issues.
• Experience developing SOPs, training materials, and technical documentation.
• Proficiency with standard business and reporting systems.
• Ability to travel extensively (50-70%) as required.
• Bachelor's degree in a related field preferred; relevant industry experience may substitute.

Health Screenings & Other Requirements

• Background checks will be conducted in accordance with applicable law

• Required vaccinations and immunizations per site or client standards

Physical Demands

• The physical demands described here are representative of those required to perform essential job functions. Reasonable accommodation may be provided where appropriate.

• Employees may occasionally lift and/or move up to 25 pounds.

• Employees may be required to stand, walk sites, and access operational areas for extended periods.

Benefits

• Competitive salary based on experience.

• Health and Wellness benefits for eligible employees.

• Retirement savings plan available.

• Paid time off and sick leave.

• Opportunities for professional growth and development.

• Positive and collaborative work environment.