We are looking for an experienced leader to help will develop and implement a robust ISO-compliant global EH&S program. This individual will play a key role in driving a culture of excellence in EH&S and will guide the organization towards becoming a leader in the Life Sciences industry.
location: Woburn, Massachusetts
job type: Contract
salary: $115 - 135 per hour
work hours: 8 to 4
•Understand the organization's business environment including staff expectations, functions, products and services, and applicable regulatory and industry requirements and standards.
•Develop and implement strategy, systems, policies and procedures, in alignment with regulatory requirements, industry standards, industry best practices and ISO 14001:2015 (Environmental) and ISO 45001:2018 (Health & Safety) Management Standards.
•Perform hazard identification, risk assessment and gap analysis of current processes and develop risk-based corrective action plans.
•Ensure compliance with federal, state and local regulatory requirements, as well as, conformance to industry requirements and standards.
•Create effective training & competency programs.
•Develop EH&S metric dashboard to monitor, measure and improve program.
•Conduct formal internal audit of EH&S program on an annual basis.
•Create reports and presentations to summarize results and industry trends and report to senior leadership.
•Apply best practices to identify and facilitate improvements to business processes, facilities and equipment, including capital projects and change management.
•Participate in the design of new facilities or major revisions of existing facilities to ensure proper EH&S considerations are in place.
•Proactively seek out and engage with stakeholders to determine explicit and implicit needs, expectations and current business environment.
•Collaborate with cross-disciplinary teams in order to meet project milestones and schedule.
•Promote EH&S awareness in a manner that encourages cooperation and improves enthusiasm and morale.
•Bachelor's degree in the EH&S field; Master's degree or MBA preferred.
•10-15 years of experience in the biotech, pharmaceutical or medical device industry.
•10 years of management experience in EH&S management roles; director-level preferred.
•Certified Safety and Health Manager (CSHM) or Certified Safety Management Practitioner (CSMP) required.
•Demonstrated knowledge and experience working with FDA cGMP, FMEA and Risk Analysis required.
•Working understanding of 21 CFR Part 11, 210, 211 and 820.
•Knowledge of federal, state and local regulatory requirements as well as industry requirements and standards.
•Strong verbal and written communication skills, specifically when communicating at the executive management level.
•Strong organizational and multitasking skills, necessary in a fast-paced work environment.
•Detail oriented with the ability to troubleshoot and resolve problems efficiently.
•Cooperative - You recognize personal strengths and know when to partner to round out any knowledge area shortcomings.
skills: Environmental Sampling
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.