Director of Quality Management Systems
Diffusion Pharmaceuticals Inc. (DFFN: Nasdaq) is an innovative biopharmaceutical company developing novel therapies to improve the body’s ability to deliver oxygen to the areas where it is needed most, offering new hope for the treatment of life-threatening medical conditions.
Our lead drug candidate, trans sodium crocetinate (“TSC”), was originally developed in conjunction with the United States (“U.S.”) Office of Naval Research to treat multiple organ failure and its resulting mortality caused by low oxygen levels due to blood loss on the battlefield. Evolutions in research have led the Company to focus on addressing some of medicine’s most intractable and difficult-to-treat conditions involving cellular oxygen deficiency, or hypoxia, such as COVID-19, stroke, glioblastoma multiforme (“GBM”) brain cancer, and other conditions and diseases in which hypoxia is a critical factor which presents a significant obstacle for medical providers and is the target for TSC’s novel mechanism.
The Company is currently partnering with a German Clinical Research Organization, Arensia Exploratory Medicine, and the Romanian National Institute of Infectious Diseases to evaluate the safety and tolerability of TSC as a treatment for the low oxygen levels in COVID-19 patients.
In addition to TSC, our product candidate DFN-529 is a novel PI3K/Akt/mTOR pathway inhibitor which has completed two Phase 1 clinical trials for age-related macular degeneration and was previously in preclinical development in oncology, specifically for GBM. RES-529 has shown activity in both in vitro and in vivo glioblastoma animal models and has been demonstrated to be orally bioavailable and capable of crossing the blood brain barrier.
Diffusion Pharmaceuticals is a small, public company that works primarily through strategic outsource partners to execute product development-related activities, including Chemistry/Manufacturing/Control (CMC), clinical operations, and data management. Ultimate responsibility for all of these activities resides with Diffusion, so Diffusion seeks a Director of Quality Management Systems to evaluate, adapt and maintain a compliant and efficient Quality Management System (QMS) for the Company.
- The Director of Quality Management Systems will report directly to the Company’s Chief Executive Officer and is responsible for the strategy, administration, and direction of the Quality Assurance organization and Quality Management System, across the range of GxP activities conducted by the Company.
- This position requires a broad range of knowledge and experience with the development and manufacturing of small molecule medicinal products.
- The incumbent is expected to be a hands-on member of a cross-functional organization, with excellent leadership and interpersonal skills, in addition to demonstrated technical expertise in the areas of responsibility.
The physical demands of this job are representative of those that must be met by an employee to successfully perform the essential functions of this job, including the ability to travel as required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above job description is not intended to be an all-inclusive list of duties and standards of the position. Incumbents will follow any other instructions, and perform any other related duties, as assigned by their supervisor.
Diffusion Pharmaceuticals is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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- Ownership of the Diffusion Pharmaceuticals Quality Management System, including development and implementation of the corporate Quality strategy and all relevant policies and procedures (e.g., Change Control, Deviation Management, Corrective and Preventive Action, Document Management).
- Responsible for ensuring the QMS drives compliance to all applicable regulations while being scalable and appropriate for the organization and product portfolio.
- Responsible for continuous improvement of the QMS to ensure compliance with evolving regulatory requirements.
- Close collaboration with representatives of all Company functional areas, contractors and vendors to ensure adherence and alignment to policies.
- Work closely with the Company’s Senior Leadership to drive adoption and implementation of the QMS system and risk management process across the organization, including contractors and vendors.
- Responsible for the oversight of all product acceptance and release activities preformed on behalf of the company to ensure compliance with internal control procedures and external quality system standards.
- Responsible for the timely documentation and resolution of deviations, and Corrective and Preventative Actions (CAPA) commitments.
- Implement and oversee a process to manage internal and external audits and inspections, including resolution of any relevant findings. Activities would include sourcing, selecting and managing internal and external resources required for audit preparedness.
- Lead all QMS, data and facility inspections including preparation and management.
- Keep abreast of new regulations and Quality trends within the Pharmaceutical industry through literature review, professional conferences, and benchmarking organizations.
Experience and Qualifications
- Minimum 10 years of experience in the pharmaceutical, biotechnology or related industry.
- Minimum of 5 years of previous people management experience, including contractor and/or vendor management.
- Demonstrated knowledge and experience with cGxPs, Health Authority Regulations, Quality Management Systems and technical expertise in manufacturing processes. Working knowledge of and experience with GCP and GLP processes and systems is desirable.
- International/global experience and regulatory knowledge preferred.
- Proven leadership, organizational and management skills to coordinate cross functional decision making with executive leadership.
- Effective communication skills, including a demonstrated ability to defend an appropriate plan or position to various audiences including Health Authority inspectors.
- Ability to comprehend technical information related to analytical methods, processes, and regulatory expectations.
- Understanding and familiarity with FDA, European and other international regulatory requirements, guidelines, and recommendations for quality system implementation including but not limited ICH 10 and ISO 13485.
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- Benefits include participation in the company’s Health and Dental Care
- life insurance and paid time off plans.