Associate Director, Quality Management Systems

The Role:

Generate:Biomedicines is seeking a dynamic and experiencedAssociate Director Quality Systems and GxP Compliance to lead our Quality Systems and Compliance operations across the organization. This role will oversee core quality management functionsincluding training documentation change control deviations CAPAs audits complaints and supplier managementensuring GxP compliance and inspection readiness. Reporting to the Vice President Quality this individual will manage and develop the Quality Systems while collaborating with site stakeholders to uphold GBs commitment to regulatory excellence and operational efficiency.

This is a unique opportunity to shape and strengthen Quality systems in a fast-paced biotech environment supporting innovative therapies from development through commercialization.

Heres how youll contribute:

• Quality Systems Leadership: Serve as the Quality Lead for Quality Systems and Compliance providing strategic oversight and guidance across the company
• Collaboration with other Quality functions
• This role will be focused on Quality Systems Quality Operations and GxP compliance across the enterprise. Subject matter expertise in the other GxP disciplines (e.g. GLP GMP GDP GVP etc.) is particularly valuable.
• QMS Operations: Oversee GxP operations including change controls deviations CAPAs complaints audits and supplier management ensuring timely and accurate documentation and closure.
• Implementation validation training and maintenance of Veeva Quality Management System
• Complaint Handling: Ensure efficient intake documentation triage escalation and reconciliation of product complaints with related systems and departments.
• GxP Training: Manage training assignments through GBs training system monitor compliance and generate training completion metrics.
• System Validation: Support validation efforts for new or updated QMS systems including document review execution of test scripts and change control support. This area is also particularly important.
• Metrics & Reporting: Compile and present Quality and supplier metrics for periodic Quality Management Review meetings.
• Audit Program: Implement and oversee GBs internal audit program to ensure continuous compliance and readiness for regulatory inspections.
• Continuous Improvement: Lead initiatives to enhance QMS efficiency and effectiveness embedding a culture of continuous improvement.
• Regulatory Support: Support regulatory submissions (e.g. annual reports IND/CTA updates marketing authorizations) by providing quality documentation and input.
• Leadership & People Management: Manage and develop the Quality Systems and Compliance team fostering accountability growth and engagement.
• Collaboration: Partner with Quality Regulatory Clinical Operations IT Manufacturing and site leadership to ensure alignment with corporate goals customer expectations and global regulatory obligations (FDA EMA and other agencies)

The Ideal Candidate will have:

• B.S. with significant relevant experience is required; advanced degree in a scientific or technical discipline preferred.
• 10 years of Quality experience in biotech/pharma with a strong background in GxP compliance and Quality Systems.
• Proven track record in leading QMS operations and managing audits complaints and regulatory submissions. Prior experience partnering closely with key stakeholders in Technical Operations Regulatory Clinical Operations Biometrics etc.
• Experience implementing Veeva or other Quality Management Systems
• Experience working with global regulatory agencies (FDA EMA and other authorities).
• Demonstrated success in building and managing high-performing teams.
• Excellent project management organizational and communication skills.
• Strong problem-solving mindset with the ability to navigate ambiguity and drive continuous improvement.

Location / Work Type

Hybrid- 2-3 days a week onsite in Somerville MA. Local candidates only- no relocation provided. This is not a fully remote role.

About Generate:Biomedicines

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creationone grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation this approach aims to reduce the uncertainty time and cost associated with developing protein-based medicines.

Founded in 2018 we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need faster guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race color ancestry religion sex national origin sexual orientation age citizenship marital status disability gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Companys internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.