Director/ Senior Director, Quality Assurance
Omniox, Inc. is an IND-stage biopharmaceutical company with a proprietary protein platform that will yield multiple drug candidates to treat diseases where hypoxia and ischemia drive poor clinical outcomes, such as cancer, stroke and critical care. We have strong science, strong leadership and strong financial backing.
At Omniox, we value:
- Scientific and operational excellence
- Open-mindedness and courage
We’re seeking an experienced, highly motivated, and adaptable leader in biologics Quality Assurance to become an integral part of our corporate team. As a member of our team, you’ll plan, coordinate, and drive Quality Assurance GxP (GMP, GCP and GLP) activities at a number of contract vendors, including cGMP manufacturing CMOs and vendors, GLP non-clinical vendors and studies as well as GCP clinical vendors and studies. In addition to oversight, you’ll be responsible for conducting troubleshooting and investigations and supporting cGMP, GLP and GCP related activities, to achieve timely delivery of therapeutics to support clinical trials. You’ll work as a part of a highly collaborative cross functional team to support IND filings and serve as a subject matter expert on these cross-functional teams. This is an opportunity to learn, to grow and to achieve at the leading edge of science and medicine. This role will report to the Vice President Manufacturing.
● Defines clear Quality objectives (cGXP) and ensures progress and cross-functional completion of responsibilities; uses judgment to develop solutions, and drives risk analysis and mitigation strategies
● Work with a diverse organization that may include both internal and external resources and be distributed over a wide geographic area. Responsible for operating all activities in a manner that complies with appropriate quality, safety, regulatory and legal requirements
● Provides expertise for product quality decisions and oversees the quality control testing program
● Manage CMO/CRO/CXO relationships, to include planning, coordination and Quality oversight of activities. Serve as primary Quality contact to support these activities.
- Run and document appropriate meetings, manage and ensure timely communication between the contract sites and Omniox management.
● Provide Quality leadership and direction to CMO/CROs/CXO and internal activities
● Implement a Quality Manual systems approach
● Responsible for documentation systems, Quality systems, compliance and auditing, as well as lot release and related activities.
● Support manufacturing campaigns with Person-in-Plant activities, deviation investigation and closure, and batch record review for batch release.
● Participate in preparation and review of regulatory filings
● Act as subject-matter expert on cross-functional teams; collaborate closely with manufacturing, QC, Regulatory Affairs, Biology, Clinical and other company team members.
● Present Quality information to diverse audiences in a clear and consistent manner
● Provide vision regarding evolution of the organization from Phase 1 to Commercial.
● Recruit for, manage and develop the QA organization
- BS/BA degree inChemistry, Biochemistry, Chemical Engineering or arelated discipline and at least twenty years of experience in a biopharmaceutical environment orrelated experience
- MS/MAdegree inChemistry, Biochemistry, Chemical Engineering or arelated discipline and at least fifteen years of experience in a biopharmaceutical environment orrelated experience
- Recent experience in implementing Quality systems in a small pharmaceutical/biotechnology company with early-phase clinical development assets is a major plus.
· Experience supporting cGMP manufacturing through all phases of development (pre-IND to commercial); must have experience with IND filings
· In depth experience with FDA, EMA and industry and international regulatory and safety standards and guidelines 21 CFR parts 11, 50, 54, 5658, 210, 211 etc., EUDRALEX, ISO, etc.
· Experience in writing of IND, NDA and BLA submissions and product launch a plus
· Hands on experience with all aspects of the start-up and implementation of Quality Systems in a pre-IPO biotechnology company
· Strong working knowledge of current Regulatory Guidelines
· Demonstratedability to multi-task in high pressure, changing conditions in a global development and manufacturing environment. Ability to prioritize competing activities and effectively present prioritized actions for others to execute.
· Demonstratedability to successfully manage and direct 3rd party vendors supplying products and services. Excellent communication, interpersonal skills, and people management skills through all levels of the organization.
· Frequent domestic and international travel is required to support manufacturing campaigns; must be able to work flexible working hours including weekends and holidays, as occasionally required
· Must have biologics experience.
We offer competitive compensation, including base salary and bonus, stock options, health benefits and paid time off.
Please send your resume and cover letter to firstname.lastname@example.org
Omniox is an equal opportunity employer. Wewill consider all qualified applicants without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.