Associate Director, Quality Systems and Compliance
$185,000–$225,000 year
On-siteCambridge, Massachusetts, United States
Job Summary
Lead and manage the end-to-end onboarding and qualification process for commercial treatment centers and transportation providers, including pre-classifications, quality system evaluations, and risk mitigation strategy development. Conduct on-site and remote audits, manage reportings and findings, and track Corrective and Preventive Actions to closure. Draft, negotiate, and maintain Quality and Technical Agreements while overseeing the Qualified Supplier List and ensuring adherence to FDA 21 CFR regulations and internal Quality Management Systems. Drive continuous improvement initiatives through SOP development, training delivery, and gap analysis to strengthen treatment center capabilities and support long-term commercial growth. Ensure organizational readiness for regulatory inspections by maintaining documentation, training, and compliance with GxP areas. Collaborate cross-functionally with Commercial, Procurement, and Quality teams to optimize compliant strategies and drive performance metrics. Based in Beam NC with up to 25% potential travel.
Required Qualifications
- 12+ years' experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality
- 4+ years' experience working with Veeva
- Direct experience with managing commercial treatment centers and executing audits
- Working knowledge of US and EU cGMP regulations and guidance including knowledge of FACT and JACIE accreditation
- Experience interacting with regulatory health authorities' inspections
- Excellent verbal and written communication skills (technical writing)
- Detail-oriented personality
- Ability to work collaboratively across functions
- Attention to detail and adherence to timelines
- Experience with Lean Manufacturing and/or Continuous Improvement efforts
- Ability to communicate throughout all levels of the organization
- Independently troubleshoots problems and issues
- Called upon to train or assist others for a large portion of the job
- Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, and analytical testing
- B.S. in science, engineering, biochemistry, or related discipline, or its equivalent
Desired Qualifications
- ASQ CQA audit certification
- Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry, or related discipline, or its equivalent, is preferred
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