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Director Of Quality Assurance
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At Proclinical, we are seeking a dynamic individual to fill the role of Director of Quality Assurance, based in Fargo, ND. The successful individual will establish and maintain continuous improvement of all aspects of cGMP Quality Operation functions through all phases of product development. Additionally, the role will include managing QA responsibilities to support the manufacturing, testing and release of finished product under FDA/EU regulations, standards and internal procedures, as well as investigating into GMP-related issues.
Responsibilities
- Oversee the internal and external audit program.
- Manage documentation, reporting, and closure of compliance issues.
- Develop, support and/or administer GMP training regularly to the facility.
- Plan, direct and manage the work of assigned Quality group(s).
- Serve as primary internal and external QA/regulatory contact.
- Manage QA relationships with GMP service providers.
- Manage audit program against relevant standards, requirements and regulations.
- Oversee and manage all aspects of quality functions for Quality Systems.
- Conduct and chair the Quality Management Review meetings.
- Identify, assess and communicate QA strategies, metrics, gaps and compliance risks to senior management.
- Tracking, trending all KPIs and design action plans to address trends.
- Monitor the regulatory environment globally and provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to provide assessments of the impact of new and changing regulations.
- Lead and implement cross-functional corporate quality audit program to monitor organization's compliance.
- Lead regulatory inspections and work directly with clients before, during and after facility audits.
- Responsible for the disposition of both incoming and final materials.
- Chair MRB meetings to disposition nonconforming products.
- Report relevant information to the General Manager on a regular and consistent basis.
- Maintain high level of awareness, expertise in applicable domestic and international regulations.
- Ensure training and cross-training of the employees of the Quality Assurance department. Perform regular performance appraisals of the employees.
- Track department metrics and provide monthly progress reports.
- Direct the generation and implementation of performance and training programs.
- Hire, train, motivate, lead, develop and evaluate staff assigned to the department, facilitating and assisting in their growth.
- Establish goals, objectives and measures to drive continuous improvement of the Validation department.
- Ensure that departmental performance adheres to established performance metrics. Ensures departmental tasks are completed by their established target dates.
Skills And Qualifications
- BA in life sciences required.
- 10+ years of relevant experience in a Quality position required.
- Direct experience with regulatory audits, including direct interface with inspectors.
- Strong knowledge foundation of FDA and EU regulations regarding the manufacture of biologics.
- Excellent written, verbal, and interpersonal communication skills.
To Apply:
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sam Milam at (+1) 3475898643 or upload your resume on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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