Senior Manager, Quality Assurance Vendor & Audit Management New Somerville, MA

Genetix Biotherapeutics Inc.; Somerville (MA); Hybrid; USD 160,000 - 180,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Disability insurance

Employer-matched 401(k) plan

Lifestyle spending account

Paid time off & holidays

Tuition reimbursement & loan repayment

Job summary

Genetix Biotherapeutics Inc. in Somerville, MA is hiring a Senior Manager of QA Compliance to lead vendor qualification, supplier oversight, and GxP audit programs in a fast-paced biotech setting.

You will develop risk-based audit strategies, manage audits of CMOs, CROs, labs, and distributors, and ensure inspection readiness while collaborating with Legal, Regulatory, and Operations. This hybrid role requires 8–10 years' QA leadership and a life sciences degree.

Qualifications

• Bachelor's degree in Life Sciences, Pharmacy, Biological Sciences, Engineering, or related discipline and 8–10 years in Quality Assurance is required.
• 8+ years of Quality Assurance, Compliance, Auditing, or Quality Systems experience within Biotechnology, Cell & Gene Therapy, Pharmaceuticals, Medical Devices, or related regulated industries.
• Prior experience managing personnel and compliance programs.
• Extensive experience conducting and managing GxP audits.
• Strong experience qualifying and overseeing CMOs, CROs, laboratories, suppliers, logistics providers, and other regulated vendors.
• Experience supporting regulatory inspections and responding to health authority observations.
• Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence

Responsibilities

• Lead the qualification, approval, requalification, and monitoring of GxP vendors, suppliers, CMOs, CROs, laboratories, distributors, and service providers.
• Develop and maintain risk-based vendor management processes and procedures.
• Perform supplier risk assessments to determine qualification requirements and audit frequency.
• Oversee vendor performance monitoring, including quality metrics, complaint trends, deviations, CAPAs, and service level performance.
• Maintain the Approved Vendor List (AVL) and ensure vendor records remain current.
• Review and approve vendor qualification packages, quality assessments, and associated documentation.
• Partner with Procurement and business stakeholders to ensure supplier selection aligns with company quality requirements.
• Develop and execute annual risk-based internal and external audit programs.
• Manage audits of CMOs, CROs, logistics providers, treatment centers, critical suppliers, and distributors.
• Lead or oversee onsite, remote, and hybrid audits.
• Manage Vendor Audit schedule
• Perform initial qualification audits and routine requalification
• Ensure audit observations are appropriately documented, classified, and communicated to stakeholders.
• Review and approve audit reports and monitor closure of audit-related CAPAs.
• Evaluate effectiveness of corrective and preventive actions resulting from audits.
• Present audit trends, metrics, and compliance risks to senior leadership.
• Support development and review of Quality Agreements.
• Ensure agreements clearly define GxP responsibilities between parties.
• Collaborate with Legal, Regulatory Affairs, Technical Operations, and business functions to negotiate quality requirements.
• Track Quality Agreement status and ensure timely renewals and updates.
• Ensure vendor management and audit programs comply with FDA, EMA, and other applicable regulations.
• Support regulatory inspections and client audits involving vendor qualification and supplier oversight activities.
• Maintain a state of inspection readiness through proactive compliance monitoring.
• Assess emerging regulatory expectations and implement process improvements as needed.
• Drive continuous improvement initiatives for supplier oversight and audit management processes.
• Develop and monitor KPIs and quality metrics.
• Identify systemic compliance risks and elevate significant issues to leadership.
• Support investigations, change controls, deviations, and CAPAs related to suppliers and audit findings.
• Ensure procedures remain current with evolving regulations and industry best practices.
• Lead, mentor, and develop QA Compliance professionals responsible for vendor management and audit activities.
• Establish departmental objectives aligned with corporate quality goals.
• Manage resource planning, budget forecasting, and departmental performance metrics.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

Skills

Vendor management

GxP audits

Auditing leadership

Regulatory compliance

Quality metrics

Education

Bachelor's degree in Life Sciences / related

Job description

Senior Manager, Quality Assurance Vendor & Audit Management

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.

This is a full-time hybrid position based in our Somerville, Massachusetts (Assembly Row) office, with an onsite presence required three days per week. Candidates must reside within a commutable distance of the office to be considered.

Position Description

The Senior Manager, QA Compliance - Vendor & Audit Management is responsible for leading the Genetix's vendor qualification, supplier oversight, and GxP audit programs to ensure compliance with applicable regulatory requirements, industry standards, and company procedures. This role oversees the lifecycle management of suppliers, contract manufacturing organizations (CMOs), contract research organizations (CROs), laboratories, treatment centers, and other GxP service providers. The individual develops and maintains a risk-based audit strategy, drives supplier quality improvements, and supports inspection readiness across the organization.

Job Duties and Responsibilities

• Lead the qualification, approval, requalification, and monitoring of GxP vendors, suppliers, CMOs, CROs, laboratories, distributors, and service providers.
• Develop and maintain risk-based vendor management processes and procedures.
• Perform supplier risk assessments to determine qualification requirements and audit frequency.
• Oversee vendor performance monitoring, including quality metrics, complaint trends, deviations, CAPAs, and service level performance.
• Maintain the Approved Vendor List (AVL) and ensure vendor records remain current.
• Review and approve vendor qualification packages, quality assessments, and associated documentation.
• Partner with Procurement and business stakeholders to ensure supplier selection aligns with company quality requirements.

Audit Program Management

• Develop and execute annual risk-based internal and external audit programs.
• Manage audits of CMOs, CROs, logistics providers, treatment centers, critical suppliers, and distributors.
• Lead or oversee onsite, remote, and hybrid audits.
• Manage Vendor Audit schedule
• Perform initial qualification audits and routine requalification
• Ensure audit observations are appropriately documented, classified, and communicated to stakeholders.
• Review and approve audit reports and monitor closure of audit-related CAPAs.
• Evaluate effectiveness of corrective and preventive actions resulting from audits.
• Present audit trends, metrics, and compliance risks to senior leadership.

Quality Agreements Management

• Support development and review of Quality Agreements.
• Ensure agreements clearly define GxP responsibilities between parties.
• Collaborate with Legal, Regulatory Affairs, Technical Operations, and business functions to negotiate quality requirements.
• Track Quality Agreement status and ensure timely renewals and updates.

Regulatory Compliance & Inspection Readiness

• Ensure vendor management and audit programs comply with FDA, EMA, and other applicable regulations.
• Support regulatory inspections and client audits involving vendor qualification and supplier oversight activities.
• Maintain a state of inspection readiness through proactive compliance monitoring.
• Assess emerging regulatory expectations and implement process improvements as needed.

Quality Systems & Continuous Improvement

• Drive continuous improvement initiatives for supplier oversight and audit management processes.
• Develop and monitor key performance indicators (KPIs) and quality metrics.
• Identify systemic compliance risks and elevate significant issues to leadership.
• Support investigations, change controls, deviations, and CAPAs related to suppliers and audit findings.
• Ensure procedures remain current with evolving regulations and industry best practices.

Leadership & People Management

• Lead, mentor, and develop QA Compliance professionals responsible for vendor management and audit activities.
• Establish departmental objectives aligned with corporate quality goals.
• Manage resource planning, budget forecasting, and departmental performance metrics.
• Foster a culture of quality, compliance, accountability, and continuous improvement.

Required Education, Experience, or Qualifications (or equivalent)

Education

• Bachelor's degree in Life Sciences, Pharmacy, Biological Sciences, Engineering, or related discipline and a minimum of 8 -10 years in Quality Assurance is required

Experience

• 8+ years of Quality Assurance, Compliance, Auditing, or Quality Systems experience within Biotechnology, Cell & Gene Therapy, Pharmaceuticals, Medical Devices, or related regulated industries.
• Prior experience managing personnel and compliance programs.
• Extensive experience conducting and managing GxP audits.
• Strong experience qualifying and overseeing CMOs, CROs, laboratories, suppliers, logistics providers, and other regulated vendors.
• Experience supporting regulatory inspections and responding to health authority observations.
• Demonstrated success engaging teams and stakeholders for collaboration in advancing quality outcomes and operational excellence

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

$160,000 - $180,000 USD

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.