Genetix Biotherapeutics

Genetix Biotherapeutics

Sr. Manager, Quality CSV

Somerville, MA · Senior · Full-time

Sponsorship not specified$170k-$180kDetected 61 days ago
FDA RegulatoryCollaborationCritical ThinkingGxP

About the role

  • This is personal and we approach every challenge with radical care.
  • This is a full-time hybrid position (3 days a week) in our Somerville - Assembly Row, Massachusetts office.
  • Additional Information The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.

Responsibilities

  • Collaborate with IT to ensure internal CSV processes and procedures are aligned to GAMP 5, 21 CFR Part 11, EU Annex 11, ICH Q9 (risk management), ICH Q10 (PQS), and FDA's Computer Software Assurance (CSA) guidance.
  • Drive the shift from documentation‑heavy CSV to risk‑focused CSA, maximizing testing on features that impact patient safety, product quality, and data integrity.
  • Support internal/external audits and inspections.

Requirements

  • Bachelors' and/or master's degree in computer systems, engineering or related field required.
  • A minimum of 7 years of experience in the industry with 5 years of direct CSV experience in GxP environment.
  • Thorough knowledge and experience with change control process.
  • Ability to work independently and handle multiple projects in a fast-paced environment.
  • Prior involvement in regulatory inspections with strong inspection-readiness skills.
  • Strong analytical and critical thinking skills.
  • High attention to detail and commitment to data integrity.
  • Collaboration and relationship-building across functional areas.
  • Additional Information
  • The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. We may ultimately pay more or less than the posted range, and the range may be modified in the future. This role is eligible for an annual bonus and long-term incentive. Actual base salary pay will be based on several factors, including but not limited to experience, skills, relevant education/qualifications, external market, internal equity, and other job-related factors permitted by law.
  • Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs. These benefits include comprehensive health, life and disability insurance, employer-matched 401(k) plan, lifestyle spending account, flexible time-off + paid holidays and winter holiday period, tuition reimbursement & loan repayment assistance, paid parental leave, paid onsite parking, commuter subsidy, and much more.
  • Pay Transparency
  • $170,000 - $180,000 USD

Nice to have

  • Hands-on experience with Veeva Vaults preferred.

Compensation

  • $170,000 - $180,000 USD
  • Additional Information The pay transparency range provided below is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.

Benefits

  • Approve validation deliverables (validation/assurance planning, testing strategy, traceability, UAT, periodic review, and retirement/archival plan, risk assessments, protocols, reports).
  • This role is eligible for an annual bonus and long-term incentive.
  • Genetix's total rewards package also provides employees with a comprehensive and competitive benefits suite to support a variety of employee needs.

Company info

  • Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints.
  • About Genetix Biotherapeutics
  • At Genetix Biotherapeutics every role has meaning, every team member is respected, and every day is a chance to make a difference.
  • When you join Genetix, you're not just landing a new role, you become part of a company that's pursuing curative gene therapies to give patients and their families more days.

Equal opportunity

  • Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.
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This listing is sourced directly from Genetix Biotherapeutics's careers page and normalized into a canonical job model.