- Ensurethat GMP activities performed in BioManufacturing are in compliance with applicable phase/stage appropriate regulations and guidance . Oversee and approve all lot disposition decisions for BioManufacturing.
- Being an engaged member of the BioManufacturing leadership team- participating in business management processes and partnering with leaders at the site to drive performance and improvements.
- Manage the Quality Assurance and Quality Control teams in BioManufacturing- delivering timely performance evaluations, development planning and hiring of qualified talent in alignment with 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 compliance with all applicable regulatory requirements.
- Establish and manage a periodic Quality Council for BioManufacturing- provide periodic updates to senior management in Akron regarding Quality risks/issues
- Implement and manage new Quality management applications and systems (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 oversee response and action plan to inspection findings. Work with customers to resolve quality issues.
- Conduct compliance inspections and audit of contract manufacturers and vendors/suppliers of products utilized by Akron BioManufacturing.
- In partnership with the GM, BioManufacturing, contributes to the development and management of the annual operating plan (budget) for BioManufacturing Quality
- Ensure a safe working environment for all Quality Assurance and Quality Control colleagues.
- BS in a life science or related discipline.
- At least 15 years of industry related (biotechnology/advanced therapies) Quality experience with at least 5 years of managing teams/people
- Expertise with CFR, GMP, GLP, ISO-9001, ISO 13485 regulations and standards.
- Expertise in aseptic manufacturing is required.
- Experience leading or participating in cross functional teams.
- Strong collaborative leader who can be decisive on quality and regulatory compliance issues.
- Inspirational communication and interpersonal skills; ability to serve as a mentor to direct reports.
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Director, Quality - Sarasota, United States - Akron Bio
5 days ago
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.
The Director of Quality, BioManufacturing, is responsible for oversight of Quality Assurance and Quality Control at Akron's BioManufacturing facility in Sarasota, FL. The position has a matrix reporting structure into the GM, BioManufacturing and the CEO of Akron Bio. The responsible individual will partner with the Head of Quality, BioProducts on Quality/Regulatory issues impacting the broader Akron Bio business.
Responsibilities include:
