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Senior Manager Quality Assurance

Cambridge, MA
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, 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.

Vor Biopharma is thrilled to have been chosen as the 2019 Xconomy Cell Therapy Platform of the year. We are well-funded by 5AM Ventures and RA Capital, among others. Please visit our website at https://www.vorbiopharma.com/ for more information.

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

As an equal opportunity employer, we at Vor Biopharma 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.

Who we are looking for
The successful candidate will be responsible for supporting continuous improvement initiatives for Vor Quality Systems by prioritizing and coordinating batch release activities in conjunction with Contract Manufacturing Organizations (CMOs). As a team member, the candidate will work cross-functionally in a collaborative environment with department managers and personnel to support corporate strategic objectives.

Key areas of responsibility:
  • Manage the Quality Systems operations to ensure ICHQ7A and cGMP compliance and validation activities. Responsibilities include:
    • Assist in the collaborative selection/qualification and management of vendors for raw material, drug substance, and drug product manufacturing
    • Management of product disposition, including raw materials, intermediates, drug substance, drug product, packaging, and transport of drug product
    • Review batch records, quality control data, analytical methods transfer and validation, and oversee resolution of quality assurance activities, including OOS and OOT investigations, and CAPAs and product complaints
    • Ensure drug substance and drug product stability programs are initiated, reviewed, and approved at appropriate time points. Prepare quality agreements with vendors and CMOs
  • Participate in the review and approval of critical documentation such as analytical methods, specifications, reports, and protocols, including comparability and compatibility
  • Manage document control systems that are Part 11 compliant to accurately capture all documentation, revisions, justifications, and decisions
  • Develop and write quality assurance department standard operating procedures (SOPs)
  • Review and approve SOPs assuring consistency of policies and practices across technical disciplines
  • Manage the internal and external audit programs
  • Participate and represent Quality Assurance on development project teams
  • Organize and manage employee training programs, including specific GxP training, maintain training records, and initiate training sessions
  • Support compliance for GLP studies. To include assay qualification, validation, and characterization of product used for GLP studies
  • BSc, MSc, or equivalent life sciences degree with a minimum of 10 years of pharmaceutical industry experience, including 4 years in Quality Assurance, Biologics experience preferred
  • Experience with cell and gene therapy products, a ‘plus’
  • Knowledge of cGMP and ICH requirements for pharmaceutical development and manufacturing, including technical knowledge of analytical and standard compendial physical, chemical, and microbiological methods
  • Experience in regulatory inspections, including dealing with compliance issues identified by regulatory authorities
  • Ability to independently assess R&D and manufacturing activities for compliance with regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions
  • Demonstrated history of helping develop a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives
  • Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines
  • Open, available, transparent communicator with strong leadership, presentation and influencing skills, and problem-solving ability
  • Experience in managing relationships with internal departments, external vendors, and partners in a collaborative, constructive manner
  • Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively,
  • Proficiency with MS Office, MS Word, MS Project, PowerPoint, and eCTD format
  • Estimated 25% travel required
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