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Compliance and Environmental Health & Safety Manager

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Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Compliance and Environmental Health & Safety Manager to support the commercialization of its novel biomarker products.

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If you have any questions you may contact the Talent Acquisition Manager, Renee Daniels at renee.daniels@biomerieux.com


JOB TITLE: Compliance and Environmental Health & Safety Manager
REPORTS TO: Vice President Clinical & Regulatory Strategy

Astute Medical, Inc. is an in-vitro diagnostics company dedicated to improving  the diagnosis of high-risk medical conditions through the identification and validation of protein biomarkers that can serve as the basis for novel in-vitro diagnostic tests. To support the commercialization of its novel biomarker products, Astute Medical is seeking an energetic, self-motivated individual who can fill the role of Compliance and Environmental Health & Safety Manager.

 

JOB SUMMARY:

The Compliance and Environmental Health & Safety Manager has direct responsibility for Compliance (including ethics and privacy) and Environmental Health & Safety Manager programs for Astute Medical, including their development, implementation, strategy, management, and oversight. This individual will be responsible for leading the operational efforts of the Compliance and Environmental Health & Safety Programs which includes implementing and maintaining programs and infrastructure designed to ensure that Astute Medical, Inc. meets statutory and regulatory requirements relating to ethics, data privacy, and environmental health and safety activities. This role is also responsible for drafting and obtaining approval for policies; establishing and executing internal controls; and establishing procedures to promote compliance with those policies.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

This position is responsible for leading and reinforcing compliance and creating a culture of safety by providing strategy and leadership through 2 key roles:

Environmental Health and Safety

  • Reviews applicable Cal/OSHA General Industrial Safety Orders (“GISO”) and other Safety Orders.
  • Develops, initiates, maintains, and revises policies and procedures for the general operation of the Environmental Health and Safety Program and its related activities and, with the support of Senior Management, ensures practices are followed.
  • Monitors safety policies, procedures and practices to ensure alignment with current State/Federal regulations; identify impact of required changes and develop response strategies.
  • Works with scientific staff to build and maintain up-to-date chemical inventories and supporting documentation (e.g., Safety Data Sheets (SDSs)).
  • Investigates, documents and reports (as needed) all accidents, injuries, illnesses, and unusual events.
  • Provides leadership and oversight to company safety team.
  • Develops, tracks, and communicates safety metrics to managers, employees and Senior Leadership Team.
  • Conducts periodic and scheduled internal inspections and host external inspections.
  • Partners with operating divisions, ensuring a collaborative approach to positively influence safety requirements and best practices within the organization.
  • Documents corrective actions related to safety violations and workplace injuries.
  • Maintain records in compliance with all company, industry, and regulatory requirements.
  • Schedules and facilitates annual occupational safety training.

Compliance Ethics (Privacy and Ethics)

  • Develops, initiates, maintains, and revises policies and procedures for the general operation of the Compliance/Ethics and Privacy Program(s) and its related activities; manages day to day activities and, with the support of Senior Management, ensures practices are followed.
  • Develops and coordinates annual compliance and audit with external parties.
  • Provides guidance to stakeholders when specific compliance issues arise and facilitates communications with external resources.
  • Partners with Corporate operating divisions, ensuring a collaborative approach to positively influence compliance requirements and best practices within the organization.
  • Serves as GDPR (General Data Protection Regulation) Business Representative.
  • Prepares documents, data flows, and other materials related to new data sourcing activities for Data Protection Impact Assessments (DPIAs). Work with various Corporate business units to develop business and technology solutions to ensure products and services meet corporate privacy and compliance requirements.
  • Stays abreast of relevant legislation, regulatory requirements, guidelines, and industry developments relating to data protection, privacy, security, and data governance. Provide analysis of impacts to key stakeholders.
  • Ensures ongoing education and training of internal business partners on risk and compliance related topics in response to ongoing or new legal and compliance requirements and in remediation of compliance issues.
  • Monitors the performance of the Compliance Program and relates activities on a continuing basis, taking appropriate steps to improve its effectiveness.

KNOWLEDGE/SKILLS/ABILITIES REQUIRED:

  • Bachelor’s degree, minimum qualification.
  • 3 – 5 years’ EH&S/compliance-related experience (e.g., Cal/OSHA, EPA, CERS, permiting, HIPAA, GDPR, etc) in healthcare, specifically in diagnostic, medical device, or biotech industry. Prior experience with State and Local governments preferred.
  • Demonstrated experience identifying and resolving compliance and safety issues.
  • Ability to work independently, exercise sound judgment, manage diverse and conflicting priorities and projects in an effective manner, and meet deadlines.
  • Strong communication skills (verbal & written) including ability to interact positively with all levels of the organization.
  • Ability to work cohesively with multi-disciplinary scientific working groups.
  • Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups.
  • Ability to research, obtain, coordinate, and integrate feedback and directions from diverse operational groups and organizations into a written product or presentation.
  • Ability to maintain the confidentiality of sensitive or private matters while performing job duties and interacting with colleagues.
  • Ensure compliance with Company’s Quality Management System and ensure that all individuals reporting to him/her comply with the Company’s Quality Management System.
  • Proficient with Microsoft Office suite.

PHYSICAL DEMANDS:

While performing the duties the employee is:

  • Constantly required to reach computers and other office equipment
  • Constantly required to view objects at close and distant ranges
  • Frequently required to communicate with others
  • Frequently required to sit
  • Frequently required to stand
  • Frequently required to use fine manipulation and simple grasping in order to handle laboratory equipment and to utilize the computer and other standard office equipment such as telephone, fax machines, copiers, etc.
  • Frequently required to lift and transport items weighing up to 25 lbs.
  • May occasionally be required to travel to meetings, trainings etc.

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

WORK ENVIRONMENT:

Employee frequently works in an office environment with a moderate amount of noise and activity. The work environment is fast-paced and demanding. Work weeks exceeding 40 hours are required as necessary.

Primary Location: AMER-AMER-US-CA-San Diego, CA
Schedule: Full-time
Job Posting: Aug 22, 2018, 2:12:42 PM
Shift: Day Job
Employee Status: Regular

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