Senior Director of Quality

Ohana Biosciences is seeking a Senior Director of Quality to support the development of cutting-edge medical products in the field of reproductive biology.

Company Overview

Ohana is an early-stage biotechnology company founded in 2015 by Flagship Pioneering, which has founded over 40+ breakthrough companies, including Seres Therapeutics, Agios, Rubius, Moderna, Editas, Denali, and Codiak, since 2000.

At Ohana Biosciences, we are pioneering a new frontier in reproductive medicine. Built upon a world-leading understanding of sperm biology, Ohana has 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);

  • Delivering a non-hormonal, reversible, long-lasting male contraception; and

  • Decreasing the risk of disease transmission from father to offspring.

Our mission is to provide men and women 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.

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

  • Commuter benefits

  • 15 vacation days and 10+ company-paid holidays

  • 401k retirement plan, disability and life insurance

Our Culture

We are a collaborative, innovative, and enthusiastic team of 30+ employees and growing. We are highly interdisciplinary, with most scientists participating in a wide range of research projects, and creativity encouraged at all levels regarding new projects and product ideas. Our work defines the cutting edge of basic research in sperm biology.

We are located in Cambridge near the heart of America’s biotech hub. We offer an open workspace just a few blocks from the Charles River, fun perks like on-site snacks, monthly catered lunches, off-site get-togethers and other social opportunities, comprehensive, competitive health care, and more.

If you are collaborative, hard-working, and excited by the opportunity to pursue transformational science in the field of reproductive medicine, we want to talk to you.

Please email your CV or resume to careers@ohanabio.com.

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 hr@ohanabio.com.

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