About Revalia:
We're a moonshot company pushing the boundaries of biotech and drug discovery. Born out of Yale, we aim to radically rethink the traditional R&D model—and we’re backed by some of the most forward-thinking institutions out there.
We won the ARPA-H award (think DARPA for health), the same kind of program that gave rise to Siri, the Internet (ARPANET), and GPS.
Backing our mission:
$20M in VC funding
$30M in government contracts
We’re just getting started—and we’d love for you to be part of it.
About the role
Revalia is pioneering Human Data Trials — a new paradigm for accelerating translational medicine by linking donated human organs to cutting-edge research. Our platform provides biotech, pharma, and medtech innovators with unparalleled access to human biology at scale, reducing reliance on animal models and speeding the path to patients.
Location
This position is hybrid with the expectation to travel weekly to our office in New Haven, CT.
Culture Requirements
- Role model the Revalia Bio’s Company Values of world class collaboration, cultivating deep trust, relentless adaptability, and to persevere with uncommon grit.
- Display high levels of personal integrity and be able to express opinions or concerns directly and without triangulation, demonstrating honesty, openness, and a positive outlook at all times.
- Seek to promote collaboration and be curious (and not judgmental) about opposing opinions.
- Ability to adapt to changing business needs or to personal development opportunities. Able to fully embrace feedback and training to continuously improve performance and relationships.
- Display determination and perseverance to problem solve, create, innovate, and develop.
- Demonstrate commitment to own personal growth and development. Be “all -in” when participating in Company activities and programs related to personal and professional development and training.
- Commitment to the growth and development of their team including participation in 360 reviews where requested.
Soft Skill Requirements
- Excellent communication and collaboration abilities, with a proven track record of working effectively in team environments
- Strong problem-solving skills
- Attention to detail and commitment to quality
- Strong time management and ability to balance multiple priorities in a fast-paced environment
Technical Skill Requirements
- Basic understanding of risk management and quality systems.
- General familiarity with document control and learning management systems or software is expected.
- Familiarity with Title 21 CFR Parts 11 or 820, various ISO standards, and regulatory submission processes is a plus.
- Knowledge of GMP, GLP, or GDP (e.g., GxP) guidelines is a plus.
Responsibilities
- Assist in the creation, revision, and management of quality documentation, including Standard Operating Procedures (SOPs), work instructions (Wis), and forms to ensure compliance with internal policies and regulatory requirements.
- Participate in maintaining records for audits and inspections.
- Support the implementation and maintenance of the company’s QMS and eQMS, ensuring processes adhere to regulatory and quality standards, and electronic records are maintained and up-to-date.
- Assist in identifying, investigating, and documenting non-conformances, including root cause analysis, corrective and preventive actions (CAPA), and tracking the resolution of issues.
- Support the evaluation and qualification of suppliers.
- Participate in product testing and verification activities, ensuring proper documentation and reporting of test results.
- Assist in organizing and documenting internal training programs related to quality and regulatory compliance.
- Assist in conducting internal quality audits to assess compliance with SOPs and regulatory standards and help prepare for external audits.
Qualifications
Preferred: B.S. Degree in life science, quality assurance, business or related field and 1+ years of experience in quality assurance, preferably within the medical device, biotech, or pharmaceutical industries.
Accepted: A.S. Degree in life science, quality assurance, business or related field and 3+ years of experience in quality assurance, preferably within the medical device, biotech, or pharmaceutical industries.
Internship experience or academic projects related to quality control or regulatory compliance may be considered.
Compensation, Benefits, and Diversity Commitment
Revalia Bio acknowledges and celebrates the diversity of our workforce, is dedicated to creating an equitable workplace, is committed to fostering an inclusive environment, and aims to create a workplace culture where every individual feels a sense of belonging. We are an equal opportunity employer and do not discriminate on the basis of race, religion, color, national origin, sex, sexual orientation, gender, gender identity or expression, age, disability, or genetic makeup. For individuals with disabilities who would like to request accommodations, please email culture@revaliabio.com.