SHE Lead BPD

AstraZeneca • Gaithersburg, MD

3d • Onsite

About The Position

Seeking a seasoned SHE Professional to serve as the primary SHE business partner for aligned functional areas while leading comprehensive safety, health, and environmental programs across multiple AstraZeneca functions. The SHE Lead BPD is a strategic leadership role developing and implementing mid to long-term SHE strategies aligned with business objectives. This position will lead the partnership support for Manufacturing Sciences and Biopharmaceutical Development Laboratories at our Gaithersburg campus. This role would also mentors junior SHE Advisors and promotes a culture of safety excellence based on Human and Organizational Performance (HOP) principles while ensuring regulatory compliance and supporting continuous improvement initiatives. SHE Policy Development and Implementation : Develop, implement, and maintain comprehensive SHE policies and procedures aligned with regulatory requirements and company standards while ensuring site compliance with local, state, federal, and international regulations through detailed understanding and execution of compliance calendars and regulatory reporting requirements. Event Investigation and Trend Analysis : Lead all potential Serious Injury and Fatality (pSIF) or SIF event investigations while ensuring robust event descriptions, thorough root cause analysis, and implementation of effective corrective actions. Evaluate trends in event and observation reporting to implement appropriate preventive measures and drive continuous improvement across laboratory operations. Regulatory Compliance and Agency Relations : Serve as a secondary point of contact for SHE-related regulatory agencies including CDC, USDA , OSHA, and other relevant authorities while leading audits and inspections, tracking compliance trends, and ensuring timely preparation and submission of all regulatory documentation and reports. Training Program Development and Management : Develop and implement comprehensive training programs for employees at all levels to ensure compliance with laboratory and animal safety protocols and sustainability practices while ensuring training effectiveness through regular assessment and continuous improvement initiatives. Site SHE Program Management : Lead and supervise comprehensive site SHE programs including, but not limited to, process safety, management of change, pressure safety, and event investigation and learning while ensuring effective License to Operate maintenance and compliance calendar execution. Team Leadership and Development : Champion and implement HOP-based safety culture initiatives through therapeutic area meetings, one-point safety lessons, targeted training programs, and proactive engagement strategies that promote safety awareness and behavioral change across Manufacturing Sciences and Biopharmaceutical Development organizations. Provide expert consultation to project teams regarding process hazards, communicate complex technical information to diverse audiences through reports, presentations, and meetings, and mentor and assist junior team members in professional development. On-call coverage is required for this role. Employees may be scheduled to participate in an on-call rotation and must be available outside standard working hours, including evenings, weekends, and holidays, as needed to support business-critical activities.

Requirements

• Master’s degree in scientific, or SHE related field
• 8+ years in Occupational Safety, Health, Environmental role
• 3+ years of experience in biopharma R&D/Clinical Manufacturing
• Demonstrated experience with conducting risk assessments and implementing action plans, accident investigation techniques, and safety management systems.
• Strong computer/technology skills.
• Prior experience with Enablon platforms.
• Excellent written and verbal communication skills with ability to present to senior leadership and influence decision-making across all organizational levels
• Demonstrated ability to analyze data, identify trends, and provide recommendations based on analysis
• Demonstrated ability to develop vision independently and drive complex changes within processes or functions while managing high levels of change and uncertainty
• Leading cross-functional safety initiatives
• Previous experience mentoring junior staff
• Comfort with providing presentations to varying levels of the organization (ex. Scientist to VP level)

Nice To Haves

• Experience in pharmaceuticals/biotechnology industry operations and regulatory
• Prior experience in clean rooms (GMP) facilities
• CSP (Certified Safety Professional) or desire to obtain
• Expertise in areas such as process safety, environmental management, industrial hygiene, occupational health, or emergency management
• Expertise of SharePoint, Enablon, or other SHE management systems

Responsibilities

• Develop, implement, and maintain comprehensive SHE policies and procedures aligned with regulatory requirements and company standards while ensuring site compliance with local, state, federal, and international regulations through detailed understanding and execution of compliance calendars and regulatory reporting requirements.
• Lead all potential Serious Injury and Fatality (pSIF) or SIF event investigations while ensuring robust event descriptions, thorough root cause analysis, and implementation of effective corrective actions.
• Evaluate trends in event and observation reporting to implement appropriate preventive measures and drive continuous improvement across laboratory operations.
• Serve as a secondary point of contact for SHE-related regulatory agencies including CDC, USDA , OSHA, and other relevant authorities while leading audits and inspections, tracking compliance trends, and ensuring timely preparation and submission of all regulatory documentation and reports.
• Develop and implement comprehensive training programs for employees at all levels to ensure compliance with laboratory and animal safety protocols and sustainability practices while ensuring training effectiveness through regular assessment and continuous improvement initiatives.
• Lead and supervise comprehensive site SHE programs including, but not limited to, process safety, management of change, pressure safety, and event investigation and learning while ensuring effective License to Operate maintenance and compliance calendar execution.
• Champion and implement HOP-based safety culture initiatives through therapeutic area meetings, one-point safety lessons, targeted training programs, and proactive engagement strategies that promote safety awareness and behavioral change across Manufacturing Sciences and Biopharmaceutical Development organizations.
• Provide expert consultation to project teams regarding process hazards, communicate complex technical information to diverse audiences through reports, presentations, and meetings, and mentor and assist junior team members in professional development.
• On-call coverage is required for this role. Employees may be scheduled to participate in an on-call rotation and must be available outside standard working hours, including evenings, weekends, and holidays, as needed to support business-critical activities.

Benefits

• qualified retirement program [401(k) plan]
• paid vacation and holidays
• paid leaves
• health benefits including medical, prescription drug, dental, and vision coverage

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level