Director, Quality Position Available In Sarasota, Florida

Job Description:

Akron Bio is continuing to transform and further its rapidlygrowing capabilities and is now seeking highly motivatedprofessionals to join our expanding team. This is an excitingopportunity to play a critical role within our organization that isdriving advanced therapy development and commercialization withhigh quality industrial scale solutions. We manufacture anddistribute components and raw materials for cell therapy discovery,development, and commercialization to meet industry needsworldwide. We offer an array of highly competitive benefits andperks to our valued associates.

The Director of Quality,BioManufacturing, is responsible for oversight of Quality Assuranceand Quality Control at Akron’s BioManufacturing facility inSarasota, FL. The position has a matrix reporting structure intothe GM, BioManufacturing and the CEO of Akron Bio. The responsibleindividual will partner with the Head of Quality, BioProducts onQuality/Regulatory issues impacting the broader Akron Biobusiness.

Responsibilities include: Ensure that GMP activities performed in BioManufacturing are incompliance with applicable phase/stage appropriate regulations andguidance. Oversee and approve all lot disposition decisions forBioManufacturing. Being an engaged member of the BioManufacturing leadershipteam- participating in business management processes and partneringwith leaders at the site to drive performance andimprovements. Manage the Quality Assurance and Quality Control teams inBioManufacturing- delivering timely performance evaluations,development planning and hiring of qualified talent in alignmentwith the BioManufacturing resource plan. Maintenance of an effective Quality Management System (QMS)which includes, but is not limited to, batch disposition, audits,change control, deviation, investigations, and corrective actions.

Ensures that the BioManufacturing QMS is maintained in compliancewith all applicable regulatory requirements. Establish and manage a periodic Quality Council forBioManufacturing- provide periodic updates to senior management inAkron regarding Quality risks/issues. Implement and manage new Quality management applications andsystems (e.g. LIMS). Review and approve stability and validation protocols. Design and implement Quality Assurance training programs.

Deliver training to employees as required. Lead audits and regulatory inspections at the site and overseeresponse and action plan to inspection findings. Work withcustomers to resolve quality issues. Conduct compliance inspections and audit of contractmanufacturers and vendors/suppliers of products utilized by AkronBioManufacturing. In partnership with the GM, BioManufacturing, contributes tothe development and management of the annual operating plan(budget) for BioManufacturing Quality. Ensure a safe working environment for all Quality Assurance andQuality Control colleagues.

Requirements:

BS in a life science or related discipline. At least 15 years of industry related (biotechnology/advancedtherapies) Quality experience with at least 5 years of managingteams/people. Expertise with

CFR, GMP, GLP, ISO-9001, ISO 13485

regulationsand standards. Expertise in aseptic manufacturing is required. Experience leading or participating in cross functionalteams. Strong collaborative leader who can be decisive on quality andregulatory compliance issues. Inspirational communication and interpersonal skills; abilityto serve as a mentor to direct reports.

EOE/DFW #J-18808-Ljbffr