Job Description

Akron Bio 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.

Responsibilities:

• Responsible for the development, implementation and maintenance of the Quality Management System (QMS) and periodically provides reports on the performance of the QMS along with recommendations for improvement.
• 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.
• Establishes quality standards and policies, 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.
• 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. 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 Quality Review Board activities, 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 FMEA development, Risk Management activities, Master 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
• Formulates and maintains quality assurance objectives complementary to corporate policies and goals
• Manages QA personnel to meet QA objectives. Designs and implements Quality Assurance training programs for key relevant personnel
• Ensures compliance with the Quality System Regulations, cGMP and industry standards
• Writes/revises quality procedures or Work Instructions or other department operating procedures
• Provides support to audits and regulatory inspections and ensures the execution of corrective action and compliance with internal quality procedures and external standards
• 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.
• Generates audit reports, opportunities for improvement and other QA documents as required.
• Initiates CAR’s or PAR’s as needed.
• Oversees the CAPA Corrective and Preventive Action Program.
• Provides feedback and advice related to Customer Complaints.
• Hosts internal regulatory and accrediting agency compliance inspections and audits.
• Prepares responses to regulatory and accrediting agency compliance inspection and audit reports.
• 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.
• Conduct s internal investigations and audits and provides reports of investigation or audit findings to appropriate entities.
• Establishes and conducts a training program for employees on all pertinent SOPs, industry regulations and standards.
• Conducts Environmental, Health & Safety (EHS) training for employees engaged in handling biological products or potentially bio-hazardous materials.
• Conducts cGMP and cGLP training, as needed.
• Evaluates employee competence and issues training certificates as applicable.
• Oversees laboratories’ production schedule.
• Interacts with Shipping and Receiving, Operations Director and other internal groups to facilitate order processing and fulfillment.
• Participates in Management Reviews.
• Exercises sound judgment in addressing and proactively managing business issues with minimal direction and supervision.
• Performs other duties as assigned.

Requirements:

• Quality Assurance management experience.
• Knowledge of FDA, CFR, GMP, ISO-9001 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 that can also work independently to achieve objectives
• Must be 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.
• Energetic team player with strong organizational, analytical and problem-solving skills with a fundamental knowledge of marketing concepts, practices and procedures.
• Superior interpersonal and team building skills.
• Superior verbal communication and presentation skills.
• Superior English writing skills and is able to clearly convey ideas in writing.
• Possesses outstanding technical writing skills and is capable of generating SOP’s, protocols, 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.
• General understanding of Biotech industry preferred.

EOE/DFW

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