Director, Quality Assurance
Akron Biotech is continuing to transform and further its rapidly growing capabilities and is now seeking highly motivated professionals to join our expanding team. This is an exciting opportunity to play a critical role within our organization that is driving advanced therapy development and commercialization with high quality industrial scale solutions. We manufacture and distribute components and raw materials for cell therapy discovery, development, and commercialization to meet industry needs worldwide. We offer an array of highly competitive benefits and perks to our valued associates.
- Establishes quality standards, policies and procedures, performs needed organizational assessments, and manages projects in support of organizational goals and strategic objectives.
- Maintains a robust Quality Assurance Program which addresses batch disposition, deviation, investigation and corrective action.
- Responsible for the development, implementation and maintenance of the site Quality Management System (QMS) transition, and periodically provides reports on the performance of the QMS along with recommendations for improvement to senior managment.
- Develops and maintains a current Quality Manual System Manual and current Standard Operating Procedures (SOPs), guidelines, standards and records.
- Responsible for controlling new and revised documents required for the operation of the QMS pursuant to the Quality Management System Manual. Please see Manual for detailed outline of responsibilities.
- Develops staff and drives new approaches to Quality Assurance and Quality Management principles, theories, concepts and techniques.
- Develops a system for management of technical product complaints.
- Reviews and approves SOPs, protocols, reports, and production batch records.
- Leads and manages the day to day activities of all quality assurance personnel and ensures the efficiency and effectiveness of all on-site quality system activities maintaining compliance with the Quality System Regulations, cGMP and industry standards
- Designs and implements Quality Assurance training programs for key relevant personnel. Provides quality “on the floor” support for all Operations.
- Manages and coordinates all aspects of the lot review process. Ensures timely disposition of final drug product lots.
- Manages Corrective and Preventive Action System, Document Review/Traceability Release function, Final Product Disposition, and Labels.
- Represents Quality Assurance on cross-functional teams participating in various operational programs such as process development, risk management activities, validation planning, LEAN improvements, and other continuous improvement activities.
- Reviews and Approves deviations / non-conformances. Establishes effective Corrective Action Plans of all the Operations department non-conformances. Drive towards timely closure and effectiveness
- Leads, supports, and participates with the Operations functions to proactively investigate, identify, and implement best-in-class quality manufacturing practices
- Provides support to audits and regulatory inspections and ensures the execution of Corrective Action and compliance with internal quality procedures and external standards. Generates audit reports, opportunities for improvement and other QA documents as required.
- Manages the document control function.
- Conducts investigations and internal audits of procedures, forms and all associated documents consistent with cGMP, cGLP and EHS practices and guidelines.
- Initiates CAR’s or PAR’s as needed.
- Oversees the CAPA Corrective and Preventive Action Program.
- Conducts compliance inspections and audits of contract manufacturers and vendors/suppliers of products utilized by Akron Biotechnology. Prepare reports of investigations or audits findings of contract manufacturers and vendors/suppliers.
- Conducts cGMP and cGLP training, as needed.
- Evaluates employee competence and issues training certificates as applicable.
- Participates in Management Reviews.
- Exercises sound judgment in addressing and proactively managing business issues with minimal direction and supervision.
- Performs other duties as assigned.
- BS in science or a related discipline.
- 7-10 years of Quality Assurance management experience within the life sciences industry.
- Knowledge of FDA, CFR, GMP, ISO-9001, ISO 13485 regulations and standards.
- Minimum of 7 years working in the biopharmaceutical, cellular therapy, or gene therapy industries.
- Direct experience supporting the manufacturing, testing, disposition, and distribution of cGMP products in the Manufacturing or Quality organizations. Prior supervisory experience required.
- Experience in the implementation and execution of Quality Systems.
- Excellent communication, trouble shooting, and problem-solving skills.
- Strong team player, highly motivated and able to work independently while maintaining open communication with supervisor, staff and others within the Company.
- Demonstrated ability to work collaboratively with employees in other cross functional groups using a proactive approach to problem solving.
- Able to think strategically and participate in business planning meetings.
- Possesses the judgment level needed to execute plans and accomplish goals.
- Shows a high degree of initiative and is resourceful and results oriented.
- Possesses outstanding technical writing skills and is capable of generating SOP’s, protocols, procedures, policies and a variety of technical documents and reports.
- Possesses knowledge of Quality Management techniques.
- Ability to meet important deadlines.
- Strong computer skills are required – knowledge of advanced software functions such as MS Word, Excel and Power Point an ability to work well with Internet Explorer and Outlook.