Director of Quality Management Systems

Job Overview:

The Director of Quality Management Systems ensures compliance with cGMP and internal policies, procedures, and specifications. This position is responsible for performing a role in any one or more of the following functions: Quality Systems (Change Controls, Complaints, CAPAs, Investigations and Supplier Quality) and Compliance in accordance with cGMP and related company SOP's, state, federal and local laws as applicable.

Responsibilities:

• To execute and drive the site's quality policies and procedures, evaluate and where needed contribute to its continuous improvement.
• To lead quality assurance oversight of operations performed within the site, such as quality systems & compliance.
• To lead, support or contribute to the preparation, review, and approval of QA-related documentation in accordance with approved SOPs.
• To drive the timely closure of general organizational tasks including oversight and escalation of open tasks and timelines, tracking of tasks, and reporting of quality metrics.
• To ensure that the site's quality standards, practices, procedures, and documentation are in accordance with regulatory, pharmacopoeia! and company requirements as well as industry standards and best practices.
• To support regulatory and customer inspections and to maintain a state of inspection readiness.
• To lead, monitor, manage and drive continuous improvement of site Quality KPl's.
• To sponsor and manage QA related projects.
• To review and approve quality system documents to ensure that they comply with relevant SOPs, are GMP compliant and meet regulatory requirements.
• To help remedy compliance issues appropriately when identified.
• Respond to external customers.
• To lead or participate in meetings to direct others, or to report on, contribute to and/or resolve quality related matters.
• To represent QA and provide QA related expertise in various internal/external meetings.
• To monitor training completion and ensure both personal and departmental training status remains current.
• Lead team members and activities in respective areas as required.
• Perform other duties as assigned.

Qualifications:

• Bachelor's degree, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Master's degree or higher, in Life Sciences, Pharmacy, Engineering, Industrial Management, Operations, Quality is preferred.
• Minimum of 1O+ years relevant work experience in Quality Assurance or in combination with relevant education/experience.
• 5+ years of leadership experience
• Experience in successfully managing complex technical issues using structured analysis and methodology and articulating clear and concise direction to other operations staff.
• Strong experience with project and people management.
• Able to administer personnel performance evaluations.
• Demonstrate the ability to write and understand technical information and produce detailed reports.
• Demonstrates good leadership skills and the ability to establish and maintain good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate the ability to effectively train others on programs and procedures.
• Demonstrate solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.

Physical Demands:

• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary).