The Quality Systems Director leads planning and execution of quality management systems and practices with an emphasis on GTP and GMP. The Quality Systems Director leads the Quality Unit (including Quality Assurance and Quality Control) and is also responsible for the day-to-day Quality operations at the Ossium Health production site. The QS Director will also be a key contributor to the implementation and execution of Ossium’s Quality Systems in preparation for commercialization of emerging Cell Therapy products. This includes but is not limited to the implementation of policies, practices, procedures, standards, and systems necessary to ensure the compliance of site operations to global GTP/GMP regulations. This individual will be a key leader in the Ossium Health production site and a champion for quality principles and compliance within the entire organization.
The Quality Systems Director must be a strong partner with Production Operations and Manufacturing Sciences and Technology (MSAT) teams, as well as a strong partner with Business Operations teams to ensure that expectations for product quality, GTP/GMP compliance, and timelines are met.
Collaborate with other leaders across the organization and assist in the continuous improvement and lifecycle management of GMP policies and quality management system.
Provide leadership and build an exceptional team to manage the Quality Unit (Quality Assurance, Quality Control), including hiring, mentoring and developing personnel.
Responsible for overseeing/managing batch record review, CA/PA, and change control systems.
Review and approval of site procedures related to production and manufacturing activities.
Provide Quality oversight of facility design, build and qualification as needed.
Work collaboratively with leaders from Facilities and Engineering, Manufacturing, IT, MSAT, and Business Operations to ensure process compliance, accuracy and efficiency.
Lead the management review of quality compliance and operational key performance indications (KPIs) at the Ossium production facility; ensure timely mitigation of unfavorable trends.
Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal procedures to assure continued compliance.
Lead internal audits of relevant systems and facility.
Lead and host compliance audits and regulatory inspections by competent regulatory authority.
Negotiate Quality Agreements and ensure compliance.
Oversee external supplier Auditing.
Develop departmental goals and ensure timely completion of all deliverables
Represent the Quality Unit in the development, planning and execution of corporate initiatives.
Other responsibilities may also be assigned
BS in relevant science (including life sciences, medical technology, engineering or equivalent) is required, MS is preferred. Bachelor’s degree and related experience including supervisory experience, or a combination of relevant education and experience will be considered
The ideal candidate will have 15+ years of industry experience in managing Quality functions
Experience with CLIA laboratories and/or FACT accreditation is a desired
Demonstrated Quality leadership through a partnership approach with production/manufacturing to enable high quality and compliant product distribution to patients is required
Demonstrated experience building and leading exceptional Quality Assurance and Quality Control teams is required
Background in Biologics or Cell Therapy Manufacturing is required
Experience in continuous improvement and operational excellence is desired
Experience in a lead role and interactions with federal agencies, i.e. FDA
Expert knowledge of Quality Assurance in cGMP environment
Knowledge of International Conference on Harmonization (ICH) standards
Experience in developing and implementing multifaceted projects
Excellent communication and organizational skills and superb attention to detail
Experience in clinical research management and oversight, including project management in a dynamic research setting
Knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice
Experience with electronic quality management systems and document control as well as MS Office products and database applications required
Strong written and verbal skills
Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
A strong ability to quickly assess facts and make the appropriate decision when process/product quality may be impacted is required
About Ossium Health
Ossium Health deploys cellular therapeutics, bioengineering, and other regenerative medical tools to drive lasting gains in the health, vitality and longevity of human beings. We develop, process, and bank cell therapy products that apply the power of stem cell science to revolutionize treatment for patients with blood and immune diseases. At Ossium, we empower our employees, maintain the highest standards of operational excellence, and are a force for good.