Summary:
The Director of Quality Assurance and Compliance is responsible for maintaining high standards of quality, compliance, and regulatory adherence across our GLP operations. This leadership role requires extensive experience in quality assurance, regulatory affairs, compliance management, and environmental health and safety (EHS) oversight. The position involves overseeing the development and maintenance of quality systems to support the organization's commitment to excellence and adherence to relevant regulations.
Major Duties & Responsibilities:
Leadership and Strategy – 25%
- Develop and implement strategic plans for quality assurance, compliance, and safety initiatives aligned with organizational goals and regulatory requirements.
- Serve as a key leader in safety program development, implementation, and management.
- Oversee EHS functions to ensure effective identification and mitigation of workplace hazards.
- Provide direction to quality assurance, compliance, and EHS teams, promoting a culture of excellence and continuous improvement.
- Collaborate with senior management to establish quality and safety objectives and performance indicators.
Quality Systems, EHS, and Safety Management – 30%
- Oversee the development and maintenance of quality and EHS systems, including document control and training programs.
- Ensure compliance with relevant regulatory requirements and industry standards.
- Manage the implementation of safety programs to promote a compliant work environment.
- Conduct regular audits and inspections to identify areas for improvement.
- Lead regulatory inspections and audits, ensuring timely responses to findings.
Compliance, EHS, and Safety Oversight – 20%
- Monitor changes in regulatory requirements, assessing their impact and implementing necessary compliance measures.
- Develop policies and procedures to ensure adherence to industry standards and EHS regulations.
- Provide guidance to cross-functional teams on compliance and safety-related matters.
- Oversee incident reporting and investigation processes to ensure corrective actions are implemented.
Training and Development – 15%
- Develop and deliver training programs on quality systems, compliance practices, and safety protocols.
- Foster a culture of ongoing training and adherence to procedures.
- Mentor staff in quality assurance, compliance, and EHS departments to support professional growth.
Other Duties and Responsibilities as Assigned – 5%
- Perform additional tasks as required.
Knowledge and Abilities:
- Expertise in relevant regulatory standards and EHS management.
- Strong organizational, analytical, and problem-solving skills.
- Ability to adapt to changing procedures and work environments.
- Proficient in Microsoft Office Suite and capable of effective communication.
- Ability to manage multiple tasks efficiently in a dynamic environment.
Job Requirements:
- Bachelor’s degree in a scientific or related field; advanced degree preferred.
- 8+ years of experience in quality assurance, regulatory affairs, compliance, and EHS program management.
- Demonstrated experience in leading quality management systems and safety programs.
