Responsible for leading GMP compliance, occupational safety, and health (EHS) and risk management programs, aligned with corporate goals and objectives.

This position directly reports to the Executive Vice President.

This position will be focused on QUALITY AND TRAINING COMPLIANCE

DAILY JOB FUNCTIONS AND RESPONSIBILITIES:

• Develop, implement, and communicate policies, procedures and standards while ensuring conformance with regulatory requirements, corporate policies, and organizational customer process
• Ensure all work processes follow OSHA and EPA rules and regulations in sensitive environments such as GMP and Life Sciences.
• Cultivate a one-team approach by emphasizing group-level goals and by creating an environment where all team members are valued and appreciated.
• Support the customer’s environmental policies and procedures
• Identify EHS regulatory requirements applicable to the operations scope of work. Establish a regulatory calendar to assist in complying with the identified regulatory obligations.
• Assist with training activities to include but not limited to new employee safety orientation, implementation of GMP procedures such as proper gowning, sanitation, contamination prevention and good documentation practices.
• Ensure training records are monitored, complete and easily accessible based on client’s SOP
• Assess training activities and train-the-trainers to ensure the delivery of quality and relevant training is met per applicable SOP
• Manage training matrix and ensure all employees are in compliance with training per client’s SOP
• Manage and audit training recordkeeping to ensure all documentation is completed accurately as per the site/GMP requirements.

• Conduct Quality Assurance audits to ensure service agreement is being enforced and operating in compliance with the applicable quality program and regulations and customer’s SOP
• Manage Bravo Performance Management (BPM) system and generate reports, metrics and other deliverables required by Merck and regulatory agencies.
• Track and trend metrics and identify areas of concern, using BPM.
• Implement a culture of continuous improvement amongst the staff to identify potential flaws in contract operations and improve performance consistently.
• Assist with Deviation/Event management including corrective action and preventative action (CAPA) management and root cause analysis (RCA).
• Ensure SDS are maintained and readily accessible for all employees.
• Ensure the management team is following the system for auditing the use and handling of chemicals, and report expired solutions as needed.
• Continually maintain an appropriate level of awareness, knowledge, and preparedness to create a culture that prioritizes compliance, quality, and safety

KNOWLEDGE, SKILLS AND ABILITIES:

• Knowledge of US EHS regulations, OSHA standards, EPA compliance, quality and safety and other applicable regulations
• Knowledge of Good Documentation Practices GMP.Good Documenting practices may change by pharmaceutical company and GMP is the FDA standard for everything.
• Knowledge of ergonomics and how to conduct evaluations
• Strong presentation skills and the ability to provide effective training.
• Excellent analytical and problem-solving skills.
• Proficient in technology and equipment used in inspections.
• Knowledge of worker’s compensation
• Excellent written and verbal communication skills.
• Good judgment in Risk Management and integrity
• Proficient in Microsoft Office Suite
• Ability to work on a flexible schedule.

EDUCATION AND EXPERIENCE:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8 years’) or equivalent combination of education, training and 3-5 years of compliance/quality experience.
• Experience with GMP environment and Life Sciences settings highly preferred.

BRAVO! Building Services, a KBS company, is one of the largest, privately held facility support companies in the country. BRAVO! provides fully-integrated facility support solutions including janitorial, healthcare EVS, mechanical maintenance, electrical contracting, mailroom support and additional facility support and outsourcing activities. The Company is headquartered in Bridgewater, NJ and operates branch offices in Arlington, VA, Raleigh, NC, Bentonville, AR and New Castle, DE.