Director of Quality Management Systems - Baltimore

Location: Maryland, US

Job Overview:

The Director will lead the continuous improvement of quality systems, manage QA-related projects, and oversee the preparation and approval of QA documentation. This role requires strong leadership, project management, and the ability to drive quality excellence across operations.

Key Responsibilities:

• Lead the execution and continuous improvement of quality policies and procedures at the site.
• Oversee quality assurance of operations, including quality systems and compliance within the site.
• Lead or contribute to the preparation, review, and approval of QA-related documentation, ensuring compliance with SOPs.
• Manage and drive the timely closure of quality tasks, track timelines, and report on quality metrics.
• Ensure that quality standards, practices, and documentation comply with regulatory, and company requirements.
• Support regulatory and customer inspections, maintaining a state of inspection readiness.
• Lead, monitor, and manage continuous improvement of site quality KPIs.
• Sponsor and manage QA-related projects, ensuring successful outcomes.
• Review and approve quality system documents for GMP compliance and regulatory adherence.
• Address compliance issues effectively when identified and resolve them appropriately.
• Lead or participate in meetings to direct, report on, and resolve quality matters.
• Represent QA expertise in internal and external meetings.
• Ensure completion of training and maintain current personal and departmental training status.
• Lead and guide team members in respective areas of responsibility.
• Perform other duties as assigned.

Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Engineering, Industrial Management, or a related field. Master’s degree preferred.
• Minimum of 10+ years of relevant experience in Quality Assurance or a combination of education and experience.
• At least 5 years of leadership experience.
• Strong experience in managing complex technical issues with clear direction to operations staff.
• Proven track record in project and people management, with the ability to evaluate personnel performance.
• Demonstrated ability to write and understand technical documentation and produce detailed reports.
• Excellent leadership skills with the ability to establish strong working relationships across departments.
• Strong technical knowledge to make informed decisions with minimal supervision.
• Ability to analyze data, resolve complex problems, and make sound decisions.
• Familiarity with electronic Quality Management Systems such as MasterControl and Trackwise.
• Experience with federal, local, and international regulations concerning the production, testing, and release of drug substances/products.
• Knowledge of cGMPs, regulatory standards, and industry guidelines.
• Proficiency in Microsoft Office programs (Word, Excel, PowerPoint, Project, Teams, Outlook).
• Fluent in English with legible handwriting.