Director of Quality Management Systems
1 month ago
Scope of Position
The Director of Quality Management Systems ensures compliance with CGMPs and internal policies, procedures, and specifications. This position is responsible for performing leading the following functions: Quality Management Systems (Change Controls, Complaints, CAPAs, Investigations, OOS/OOTs, EQMS, Document Control) and responsible for ensuring these systems operate in compliance with global CGMPs, applicable company SOP's, state, federal and local laws, as applicable.
Responsibilities
- To execute and drive the site's quality culture, policies, and procedures. Continuously evaluate, and where needed, contribute to its continuous improvements to Quality Management Systems.
- To lead Quality Assurance oversight of operations performed within the site.
- To lead or contribute to the preparation, review, and approval of QA-related documentation per approved SOPs or applicable standards.
- 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 (e.g., Investigations, CAPAs, Complaints, Change Controls, Trends, etc.).
- To drive change to ensure that the site's quality standards, practices, procedures, and documentation are per regulatory, pharmacopeia, industry standards / best practices and adopted as deemed appropriate to company requirements.
- To support regulatory and customer inspections to maintain a state of inspection readiness.
- To lead, monitor, manage, and drive continuous improvement of site Quality Assurance 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
- Bachelors degree, or equivalent combination of education, training, and professional experience that provides the individual with the required knowledge, skills, and abilities.
- Preferred: Masters degree or higher, Life Sciences, Pharmacy, Engineering, Industrial Management, Business Administration or Operations.
- Minimum of 10 year's of relevant work experience in Quality Assurance or combination with relevant education/experience in GMP-related industries
- Minimum of 5 years of leadership experience, leading/creating high-performing teams.
- 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 and metrics.
- Demonstrates great leadership skills that include the ability to establish and maintain good working relationships with other departments, including vendors/clients, 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 (preferred: MasterControl and/or TrackWise Digital).
- Demonstrate the ability to effectively train others on concepts, programs, and procedures.
- Demonstrate a solid understanding of the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
- Fundamental understanding of CGMPs, industry, and regulatory standards, and applicable guidelines.
- Demonstrate familiarity with Microsoft Office programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
- Demonstrate the ability to maintain an 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.
- Creative and open-minded individual 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.
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