Director of Quality

Immediate Opening for a
Quality Director, Hagerstown, MD

SNAPSHOT!

In this role you will demonstrate a passion and aptitude for making the people around them better to achieve a mission. Candidates will be in a key leadership role responsible for overseeing all aspects of the company's quality management system (QMS) and corporate compliance program. This includes developing, implementing, and maintaining policies and procedures to ensure compliance with relevant industry standards and regulatory requirements.

The Director will drive a culture of quality and continuous improvement across the organization while minimizing risks associated with non-compliance.

• Develop, implement, and maintain a robust Quality Management System (QMS) that meets or exceeds relevant industry and regulatory requirements.
• Serve as the primary authority on quality and compliance matters and act as the main point of contact for internal and external audits and regulatory inspections.
• Develop, implement, and review compliance policies, procedures, and standards of conduct to identify and mitigate risk.
• Lead and manage the Quality Assurance team, providing mentorship, training, and performance management.
• Oversee the company's audit program, including internal, vendor, and third-party audits, to assess compliance with regulations and company procedures.
• Direct all compliance activities, ensuring all processes and record-keeping are fully compliant with applicable regulatory requirements.
• Conduct investigations into quality incidents, non‑compliance issues, and customer complaints, and ensure effective corrective and preventive actions (CAPAs) are implemented.
• Monitor changes in regulatory requirements and industry standards and assess their potential impact on the organization.
• Utilize data and metrics to report on quality and compliance performance to senior management, identifying trends and opportunities for improvement.
• Promote a company‑wide culture of quality and integrity through training programs and collaboration with cross‑functional teams.
• Manage supplier quality, ensuring that vendors and contract service providers meet all quality and compliance requirements.

• Bachelor's degree in a relevant field (e.g., Quality Management, Engineering, or a scientific discipline)
• 10 years of experience in a quality and compliance role within a relevant industry, with [specify number] years in a leadership position.
• In‑depth knowledge of [relevant industry regulations, e.g., FDA, GMP, ISO, etc.] and related guidelines.
• Proven experience managing regulatory inspections and audits.
• Strong leadership, management, and process improvement skills.
• Excellent verbal and written communication skills, with the ability to influence and build consensus.
• Exceptional analytical, problem‑solving, and critical‑thinking skills.
• Experience with risk management principles and corrective and preventive action (CAPA) systems.