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.