Ohana Biosciences is seeking a Senior Director of Quality to support the development of cutting-edge medical products in the field of reproductive biology.
What You’ll Do
Build and improve upon the quality system of a dynamic, growing, platform-based company with the potential to develop multiple medical product types (devices, biologics, drugs)
Establish appropriate quality organization using an optimized combination of key full-time quality associates and part-time consultants
Collaborate with Ohana leadership and staff and be a strong, practical voice for quality
Lead Ohana’s quality activities in the US and oversee to enable Ohana’s global development and commercialization strategy
Manage quality assurance functions for products in development and marketed products, including conducting or arranging audits of vendors
Serve as senior quality management representative in determining Ohana’s quality policy and ensuring overall compliance with FDA and international GxP quality requirements
Ensure procedures are practical, written in a way that is easy to understand, and compliant with applicable laws and international standards
Ensure that all personnel are trained on appropriate procedures and comply with them
Ensure effective and productive working relationship between quality organization and other functional groups, development, clinical, and manufacturing
Provide key leadership in representing Ohana during GxP compliance audits and inspections
Develop annual budget for quality activities
What Skills You’ll Bring
Bachelor’s of Science and 10+ years quality experience in quality compliance aspects of manufacturing for medical devices, biologics, and/or drugs
Expertise in establishing quality systems that comply with FDA’s 21 CFR Part 820 QSR, ISO 13485, FDA’s 21 CFR Part 211 drug GMPs, FDA’s 21 CFR Part 610 biologic GMPs, FDA Good Clinical Practice regulations, related FDA and international GxP regulations and guidance
Prior successful leadership in similar quality organization implementation and ongoing excellent performance
Ability to travel domestically and internationally as required to support Ohana’s quality system execution and compliance related tasks
Ability to thrive in an entrepreneurial and multidisciplinary environment
High level of adaptability and responsiveness to technical and business opportunities and needs
Collaborative attitude with a strong work ethic and self-motivation
Ability to think critically and creatively, and comfort asking questions and seeking clarity
Strong oral and written communication skills a plus
What We’ll Offer You
A dynamic early-stage work environment, with encouragement at all levels to be creative regarding new projects and product ideas
An opportunity to build a quality system and team, from its beginnings
Ability to support development of projects that stem from cutting-edge basic research in sperm biology and will improve the lives of patients
Generous paid family leave
Opportunities for career development and advancement, including trainings, classes, and conferences
Daily on-site snacks, coffee, Bevi, and monthly catered lunches
Comprehensive, competitive healthcare (PPO) and dental coverage through Blue Cross Blue Shield, and vision coverage through VSP
15 vacation days and 10+ company-paid holidays
401k retirement plan, disability and life insurance
Who We Are
Ohana Biosciences is an early-stage biotechnology company founded in 2016 by Flagship Pioneering, which has founded over 40+ breakthrough companies, including Seres Therapeutics, Agios, Rubius, Moderna, Editas, Denali, and Codiak, since 2000.
Ohana is pioneering a new approach to reproductive health with a novel platform of sperm-based technologies. We have created a best-in-class proprietary platform with field-defining applications including:
Developing life-changing products that will increase the success rate of assisted reproductive technologies (ARTs);
Decreasing the risk of disease transmission from father to offspring; and
Delivering a non-hormonal, reversible, long-lasting male contraception.
Our mission is to provide individuals struggling with infertility the freedom to decide when to have a family and empower them to have healthy children. Join us in transforming the field of reproductive medicine and creating technologies with the power to benefit our customers and transform the lives of their patients.
For more information please check out our website ohanabio.com.
Ohana Biosciences is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.
Note to External Recruiters: Our Human Resources department manages all open positions and candidate recruitment. We kindly ask that recruiters not contact employees or hiring managers directly to present candidates or solicit business. Please note that we will consider failure to comply with this request when determining whether to enter into a professional relationship with a recruiting agency. Please also note that submission of unsolicited resumes does not create any obligations for Ohana, implied or otherwise. If you would like to develop a recruiting relationship with us, contact email@example.com.