Director, Facility Risk Compliance

Company: Renaissance Pharmaceuticals
Location: Lakewood
Posted on: December 2, 2019

Job Description:

Overview

The Director of Ficility Risk Compliance will plan, manage, and provide team leadership to support EHS, Security and DEA Compliance activities at the manufacturing site level. Develop and authorize the implementation of site policies and procedures (SOPs) to assure compliance with government requirements at the Federal, State, and local levels (OSHA, EPA, DOT, NJDEP, OCUA, DEA), and corporate policies, and successfully implementing the same. Work with cross-functional teams to assure alignment of policies and procedures with regulatory, site and security requirements. Must be able to represent Renaissance with customers and regulatory agencies.

Responsibilities

• Site Compliance: ensure site compliance with applicable safety, environmental, wastewater, DEA, and transportation requirements for OSHA, EPA, and DOT regulations. Includes applicable state and local level regulations.
• Oversight of the DEA compliance program management system .
• Oversight of site Security Program management system with a focus on maintaining Security Industry standards, best practices and Controlled Substance Security controls.
• Oversee OSHA Regulatory areas including industrial hygiene, hazard communication, laboratory chemical hygiene plans, respiratory protection, general safety, confined spaces, lock-out tag-out (LOTO), ergonomics, forklift safety, hazardous chemical material handling and storage, behavioral base safety, recordkeeping management, workers compensation, and process safety management.
• Environmental Regulatory Expertise: Competencies to include Federal. State, and local regulations applicable to storm water, wastewater, solid waste, DEA waste, spill response, and transportation of hazardous materials.
• Audits: Manage OSHA, EPA, other regulatory bodies, insurance carrier, and Customer audits. This includes preparation for and managing responses to Agencies and Customers audit reports, managing CAPA, and tracking regulatory commitments for the Renaissance site.Budgets: Develop and maintain budgets for the EHS, DEA and Security functions in support of business initiatives and strategies.
• Customer Interface: Develop and maintain relationships with customers for current and future products.
• Internal EHS Audits: Develop plans for and manages the preparation of GAP analyses through the execution of internal audits and the development of best management practices (CAPA) to improve performance and compliance with internal policies and procedures.
• Agency Submissions: Manage or prepare all EPA and OSHA reporting requirements including, but not limited to, OSHA 300 Log, CAA, CWA, RCRA, SPCC, PSM/RMP, Storm water/waste water, Title V, SARA 311, 312, 313, and Hazardous Waste Generator and Air Emissions Inventory.
• Oversight of all security programs including, but not limited to, access control, security camera control and access, guard staffing/training.
  
  Qualifications
  
  Bachelor's Degree (BA or BS) required, preferable in Environmental Sciences, Natural Sciences (chemistry or microbiology) or Engineering. Four to ten years related experience and/or training; or equivalent combination of education and experience. Risk management experience preferred. Wide-ranging managerial and leadership skills, including compliance management, and a minimum of 15 years' experience and hands-on work. This experience should encompass applying safety and Environmental regulations and concepts on a pharmaceutical manufacturing operation, as well as DEA regulations and basic Facility Physical Security principles.
  
  Thorough knowledge of OSHA, EPA, DOT, and State regulations is required. PI115906978

Keywords: Renaissance Pharmaceuticals, Lakewood , Director, Facility Risk Compliance, Executive , Lakewood, New Jersey