Quality Head, Sarasota

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 rewards to our valued associates.
 
The Quality Head, Sarasota is responsible for Quality Assurance and Quality Control at Akron Biotech’s Sarasota operation. She/he will oversee quality at the plant through direct/indirect reporting and is responsible for quality on all Akron bioproducts. The ideal candidate will be a strong collaborator and communicator She/he will report directly to the VP, Quality of Akron Biotech

Responsibilities:

•    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 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 management.
•    Reviews and approves SOPs, protocols, reports, and production batch records.
•    Leads and manages the day-to-day activities of all quality 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.
•    Leads audits and regulatory inspections at the Sarasota site and oversees response and action plan to inspection findings.
•    Conducts compliance inspections and audits of contract manufacturers and vendors/suppliers of products utilized by Akron Biotechnology.
•    Works directly with Akron customers on quality audits and issues
•    Ensures implementation of and adherence to Quality agreements with Akron customers.
•    Oversees and adheres to the Quality budget at the Sarasota site.
  
Requirements:

•    BS in science or a related discipline.
•    At least 7 years of Quality Assurance management experience within the biotech/pharma industry.
•    Travel up to 20% of the time

Preferred Experience:

•    Expertise with CFR, GMP, GLP, ISO-9001, ISO 13485 regulations and standards.
•    Experience with product licensing approval (PLA) or other regulatory inspections (e.g. FDA, EMA)
•    Experience working on advanced therapies (e.g. cell therapy, gene therapy)
•    Experience in the implementation and execution of Quality Systems.
•    Excellent communication, trouble shooting, and critical thinking skills.
•    Experience with enterprise Quality management systems (e.g. Trackwise)

EOE/DFW