Sr. Director, Quality Systems

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. We are doers, thinkers and collaborators who embrace and live by our values:

Our innovation is rooted in the diversity of our teams and results are achieved through cooperation and the integration of multiple viewpoints. This is personal and we approach every challenge with radical care.

ABOUT US

We are seeking an experienced and strategic Sr. Director, Quality Systems to lead the commercial strategy and execution for our quality-focused biotech solutions. You will bridge the gap between product development, regulatory compliance, and customer engagement, driving growth for our quality systems portfolio in the biotech and life sciences sectors. You will bring a strong background in biotech or pharmaceutical quality systems (GMP, GCP, GLP), with proven commercial leadership experience in B2B environments. This is a full-time hybrid position (3 days a week) in our Somerville – Assembly Row, Massachusetts office.

RESPONSIBILITIES

• Commercial Strategy & Execution:
  • Maintain and monitor the company's overall QMS including KPIs / reporting for Management review responsibilities and risk management
  • Partner with IT on technology roadmap for eQMS and supporting systems (Oracle, Compliance Wire, Blue trace, etc)
  • Establish and maintain CI model for Quality processes

• Customer Engagement & Relationship Management:

• • Build strong relationships with key stakeholders, including quality, regulatory, and operations leaders within target organizations.
  • Partner with cross-functional teams to deliver tailored solutions that meet complex regulatory and quality compliance needs.
  • Collaborate with IT to ensure fit for purpose of all e-systems (CSV / CSA) and data governance
  • Lead direct team and matrix teams to execute on critical path process improvements in collaboration with business needs.

• Product & Portfolio Oversight:

• Collaborate with R&D and product management to ensure quality systems products meet market demands and regulatory standards.
• Champion VOC (voice of the customer) to guide development and improvements of quality systems tools and services.

• Regulatory & Compliance Expertise:

• Stay abreast of industry regulations (FDA, EMA, ISO, ICH, etc.) and ensure alignment in product offerings and customer guidance.
• Advise internal and client teams on compliance best practices related to quality systems (e.g., QMS, CAPA, audit readiness).

QUALIFICATIONS

• Bachelor's or Master’s degree in Life Sciences, Engineering, Business, or related field. Advanced degree (MBA, PhD) preferred.
• 10+ years of experience in biotechnology, pharmaceutical, or life sciences industry.
• Expertise in business process management and continuous improvement methodology
• Experience in computerized systems management. Direct expertise using Veeva Vault platform is preferred
• Proven track record in sales leadership, business development, or strategic partnerships.
• Exceptional communication, negotiation, and leadership skills.

Additional Information:

Base Salary Range: $236,000 - $295,000

The range provided 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 shutdown, tuition reimbursement & loan repayment assistance, paid parental leave, generous commuter subsidy, and much more.

Genetix is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment.  All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.