Medical Science & Computing (MSC) is an exciting growth oriented company, dedicated to providing mission critical scientific and technical services to the Federal Government. We have a distinguished history of supporting the National Institutes of Health (NIH) and other government agencies. MSC offers a dynamic and upbeat work environment, excellent benefits and career growth opportunities.
We attract the best people in the business with our competitive benefits package that includes medical, dental and vision coverage, 401k plan with employer contribution, paid holidays, vacation, Medical and Flexible Spending Accounts, Pre-Tax Transit Assistance and tuition reimbursement. If you enjoy being a part of a high performing, professional service and technology focused organization, please apply today!
Medical Science & Computing is searching for a Quality Assurance Manager to support the National Institutes of Health (NIH). This opportunity is full-time, and it is on site in Bethesda, MD.
Duties and Responsibilities:
- Develop, improve and manage comprehensive Quality Assurance systems. Elements include policies, procedures, electronic document management system, training, controls, measurements, corrective actions, training, change control, event management, reporting and continuous improvement. The scope covers all suppliers, manufacturing and distribution.
- Develop, maintain and improve metrics for Quality Assurance. Scope includes all supplier, internal and customer measurements of compliance and performance across the entire center.
- Provide leadership and direction to the Quality Unit; grows and develops the team to meet evolving regulatory needs; is accountable for Quality Assurance and Quality Control.
- Ensure that a robust training cGMP training program is developed and administered.
- Ensure that all products processed at the site are produced, tested, and released in compliance with SOPs, cGMP’s, and FDA requirements for Good Tissue Practices.
- Improve, develop, establish and drive contemporary Quality Systems and processes.
- Lead a Quality metrics program to enable a strong Management Review.
- Collaborate and facilitate interactions between Quality, Pharmacy and Operations teams to meet customer requirements and timelines, while maintaining compliance.
- Ensure that systems, resources, and action plans are consistently reviewed and decisions made to enable sustainable compliance.
- Manage customer complaints. Make batch rejection decisions and manage recall decisions in conjunction with the Site Leadership Team.
- Establish procedures and specifications affecting product quality and oversee the development of batch records, SOPs, and validation protocols.
- Act as the primary contact with the FDA District Office staffs and lead FDA inspections at the site.
- Direct continuous improvement initiatives to accomplish compliance, productivity, cost effectiveness and enhanced efficiencies of processes and procedures as they pertain to Quality.
- Provide for the management of customer and third party audits at the site.
- Communicate to management of critical cGMP and/or non-compliance issues.
- Be responsible for Vendor Qualification and Management, including Contract Manufacturing and Testing, pre-clinical and clinical CROs. Conduct on-site audits, and participate in regulatory inspections at contractor sites, as required.
- Provide expert technical knowledge in quality assurance in support of group, departmental and cross functional project objectives.
- Ensure that all activities are conducted in compliance with any pertinent regulatory requirements, and in accordance with scientific standards, ethical and professional values, management philosophy, established priorities, safety policies and practices of the company.
- Manage internal and/or external resources to accomplish the responsibilities of the role.
- BS, MS, or PhD in a related discipline, with a minimum of 10 years’ experience in a quality assurance or related role.
- Progressive experience in the cell processing industry required; experience working in a fast paced biotech environment preferred.
- Track record in developing and managing GxP Quality Systems through clinical phases of development to product approval.
- Thorough knowledge of ICH Guidelines, GxP and related regulatory guidances.
- Proven track record of building and maintaining strong relationships with internal and external stakeholders.
- Ability to manage deadlines and prioritize effectively, while maintaining flexibility.
- Track record of effective business process improvements and systems implementation, including strong change management skills.
- Excellent communication and interpersonal skills; able to communicate with variety of audiences and collaborate effectively with a variety of internal and external stakeholders.
- Pragmatic and strategic thinker who meets objectives and leads by example.
- Quality professional certification preferred, especially CQA.
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Medical Science & Computing is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected Veteran status.