OM1 is a leading healthcare technology company focused on providing outcomes measurement and predictive analytics for value-based and personalized healthcare. Leveraging big clinical data, standardized outcomes measures, and artificial intelligence technology, OM1 delivers a scientifically robust and clinically meaningful approach to enable stakeholders across the healthcare ecosystem to improve clinical and financial outcomes with more precise information for better decision-making.
As our Director of Quality Assurance / Regulatory Affairs, you will lead cross-functional teams on quality and regulatory requirements which will include devising and implementing strategies to meet business needs for the implementation and management of our programs and ensure ongoing commitment to continuous improvement. You'll report to the Chief Business Officer and will play a key role in implementing strategies, controls, processes, and systems to enable OM1 success and growth.
- Function as the subject matter expert for relevant Regulatory requirements, domestic and international, stay abreast of changes in regulations, and provide interpretive guidance.
- Define and implement a Quality Management System strategy that supports the business vision and strategic plan
- Execute a robust regulatory strategy that guides product development and launch throughout the product life cycle
- Support customers regulatory needs through effective collaboration with Client Services, Research, Product Management, and Engineering
- Analyze, evaluate, and present information concerning quality assurance and regulatory affairs related to current and possible future products to members of the executive management team
- Formulate and establish company policies, procedures, objectives and goals regarding Quality Assurance and Regulatory Affairs
- Responsible for the CAPA and complaint handling systems, ensuring timely reporting, adequate root cause investigations and compliance while ensuring timely resolution of resulting action items
- Host external audits by FDA, customers, or other appropriate agencies
- Evaluate and strengthen the strategic partnerships with external vendors from a Quality and Regulatory perspective
- Author, review, and critique documents that will be included in regulatory submissions and interactions
- Responsible for the Quality Management System, including development of new documents, updates to existing documents and ensuring training records for all employees are up-to-date.
- Provide oversight for necessary updates to the Quality Management System,
- Take additional responsibilities consistent with the entrepreneurial spirit of OM1 as appropriate and time permitting
- Other duties as assigned
- Bachelors degree required; scientific discipline preferred
- 5+ years of regulatory/quality assurance experience in a life sciences / biotechnology company
- Prior experience implementing regulatory strategy in small companies is preferred
- Strong communication skills to both scientific and non-scientific audiences
- Process-oriented leadership abilities that will develop and champion initiatives to continuously improve the performance of areas under their leadership, including bringing people to a new place regarding the standard for Quality
- Ability to think creatively and strategically, while managing a number of projects simultaneously
- Demonstrated capacity for understanding how to take appropriate regulatory risk to drive projects to success
- Experience working within and perpetuating a strong QMS. Direct management of a QMS strongly preferred.
- Proven management experience with strong cross-functional relationship building skills
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