We make healthy cells invisible to targeted therapies
Targeted therapies work by attacking cells that express particular proteins on their surface. Unfortunately, both diseased and healthy cells often express the same proteins, resulting in collateral damage to healthy cells.
At Vor Bio, we engineer hematopoietic stem cells (HSCs) to lack a biologically redundant target protein, then transplant these cells into the patient.
These eHSCs give rise to generations of new healthy blood cells that are effectively invisible to targeted therapies. Diseased cells displaying the target protein and are then vulnerable to attack. This process potentially broadens the therapeutic window and improves the utility of complementary targeted therapies.
What we value in our fellow Voracians
Passion: Enthusiastically driving our science toward innovative medicines
Fellowship: Fostering genuine bonds of collaboration and mentorship
Humility: Acting selflessly by putting the collective mission first
Who we are looking for:
Vor Bio is seeking a Senior Quality Assurance Specialist who will ensure deviations, change controls, and CAPAs are reviewed, approved, and closed in a timely manner. The successful candidate will support start-up activities for a new manufacturing facility and provide ongoing support for GMP activities, both internally and at CDMO. This ideal candidate will also interface closely with other cross-functional groups, including Facilities, Engineering, Quality Control, Manufacturing, Manufacturing Sciences and Technology (MSAT), and Supply Chain. This is an onsite position.
Key areas of responsibilities:
- Support management and facilitation of site review boards for CAPA, change control, and deviation
- Lead and/or support thorough investigations of internal and external deviations
- Review and approve all internal and external deviations, CAPA and Change Controls
- Provide quality oversight of CDMO QMS-related deviations, change control, and CAPA
- Ensure robust and compliant documentation aligns with regulatory standards and Vor expectations
- Initiate and own deviations, CAPA, and change controls related to quality systems
- Support the development and implementation of phase appropriate Quality Management Systems and an enterprise Quality Management System (eQMS)
- Create and facilitate training on Quality Management Systems, including but not limited to Deviation, change control, and CAPA
- Develop tools and compile metrics for reporting to management
- Participate in Quality Management Reviews and ensure departments focus on continuous improvement
- Collaborate with cross-functional teams to support continuous improvement activities
Qualifications:
- BS in Life Sciences with a minimum of 6 years of experience in a CGMP environment, with a strong knowledge of FDA and EU regulations
- Experience setting up GMP operations and systems in a new facility is beneficial
- Proficient in writing and approving Quality Systems, including but not limited to deviations, change controls, and CAPA
- Skilled in the use of root cause analysis tools
- Excellent organizational skills
- Ability to manage multiple tasks within a GxP environment
- Experience with cell and gene therapy products is a plus
- Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
- Skilled in managing relationships with internal departments and external vendors in a collaborative, constructive manner
- Solid written and verbal skills and the ability to communicate clearly, concisely, and effectively
- Must be able to work onsite at our Cambridge facility on a regular basis.
By becoming a team member here at Vor, you’ll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, parental leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. We are conveniently located in
Cambridge with easy access to public transportation and ample parking.
As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
In an effort to protect our coworkers and communities from COVID-19, where permitted by law Vor Biopharma Inc. requires all employees to be fully vaccinated against COVID-19 and up to date with their vaccination unless they receive an approved reasonable accommodation for medical or religious reasons.
Please visit our website at https://www.vorbio.com/ for more information.
