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).
165000.00 To 190000.00 (USD) Annually
