Senior Quality Specialist/ Quality Manager @ Vor Bio

We engineer stem cell transplants that shield healthy cells from 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 shielded from targeted therapies so that only the remaining cancer cells are killed. We are also developing our own CAR-T cell therapy using T cells from the same healthy donor who could potentially provide HSCs for our shielded stem cell transplant and thereby, avoid issues of donor-mismatch. We believe our CAR-T cell therapy may enable more potent and durable responses post-transplant.

Vor Bio is aiming to cure blood cancers through our novel platform combining HSC biology, genome engineering, and targeted therapies to unlock treatment options previously unavailable to patients. Come be a part of a passionate team striving to collaboratively develop a groundbreaking approach to cancer treatment, one of medicine’s greatest challenges.

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 Specialist/ Quality Manager who can work cross functionally to provide quality oversight and support to various groups for the purpose of maintaining validated state of the facility, equipment and/or systems as well as quality compliance support.

Key areas of responsibility:

Provide quality oversight of facility/utility and equipment for qualification activities.
Provide quality oversight of validation program which includes but is not limited to Commissioning, Qualification, Validation, Analytical Instruments Validation, Method Validation, and Process Validation.
Quality support for IT, Computer/Enterprise Systems Validation activities
Review of lifecycle documents such as URS, DQ, SAT, FAT, design documents, qualification protocols (IQ, OQ & PPQ) generated for the qualification and validation of equipment and systems.
Review equipment and automation qualification and validation protocols.
Carries out duties in compliance with all local, state, and federal laws and guidelines including the FDA, EU.
Provide technical support on change controls, assessing new change controls for process equipment, utilities and automation systems that are proposed and all the requirements vital to maintain a validated status. Supports process, and method validation efforts.
Provide quality oversight of engineering and validation studies, as well as data analysis and compilation of data and results into summary and final reports.
Support review and approval of generation of quality assurance policies and procedures.
Support interpret and implement quality assurance standards.
Quality expert responsible for maintaining change control system. Provide QAV support and assessments on change controls. Review for execution approval of change controls per change control SOP and client agreement.
Provides quality support for change control, deviations and CAPA’s.
Provides support for internal/external audit program
Provides quality compliance support to MFG, QC, Facilities, PD/PAD groups.
Supports continuous improvement of Vor Quality Systems
Quality support for CMMS work orders, NCRs, Change Requests
Support deviation investigations, OOS investigations, root-cause analysis and CAPA generation.
Assure ongoing compliance with quality and industry regulatory requirements.
Participate in client audits and regulatory inspections by escorting auditors and securing requested documents and data.

Qualifications:

Bachelor’s degree in sciences/engineering, minimum 8 years of biotech/pharmaceutical industry experience or 12 years of biotech/pharmaceutical industry experience in lieu of degree.

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.

Please visit our website at https://www.vorbio.com/ for more information.

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