Associate Director Quality

Monitor projects, resolve issues, or escalate appropriately to ensure on-time delivery of client projects with effective risk mitigation and stakeholder communication.,Collaborate with manufacturing and technical teams to identify root causes of problems and determine appropriate corrective and preventive actions for investigations.,Manage the review (audit) of batch production records, EM test reports, cleaning records, material release documentation, and quality control test reports.,Prepare BPR audit reports and follow up on identified deficiencies.,Ensure QA batch record review and lot release deliverables are client-focused, results-oriented, performance-driven, and compliant with internal and external requirements.,Responsible for lot disposition and release of products.,Review and approve batch production and development records for GMP regulated operations.,Review and approve ancillary facility and equipment records for GMP regulated operations.,Review and approve assay qualification, equipment, and stability protocols and reports.,Provide technical expertise for investigations and recommend data collection for quality events.,Contribute to data and information collection.,Alert management of critical issues impacting manufacturing objectives and timelines, offering achievable solutions.,Manage the walkthrough program in GMP Manufacturing, quality control testing, storage, and material receiving areas for procedural compliance.,Oversee the revision, issuance, and tracking of controlled documents supporting bulk and sterile fill biologic products.,Drive continuous improvement and operational excellence through self-detecting and self-correcting processes, fostering ownership and accountability.,Actively participate in recruiting, onboarding, and developing new staff members.,Perform Quality Control data and audit trail review.,Willingness to cross-train and support other functional Quality areas (e.g., Quality Systems, Training, Document Control, Supplier Quality).

BS/BA required; MS preferred in scientific/technical discipline.,Minimum of 8 years of experience in a Quality department leadership role within the biological and/or pharmaceutical industry.,Experience preferred with CDMO business and/or gene-modification modalities, cell-based gene therapies.,Experience in reviewing quality control test reports and batch production records for clinical and commercial pharmaceutical/biopharmaceutical manufacturing.,Excellent working knowledge and practical implementation of FDA, EMA, and ICH regulations and guidelines.,Experience in TrackWise is preferrable.,Exceptional interpersonal skills, including ability to influence behaviors and negotiate/resolve challenges with poise, tact, and diplomacy.,Exceptional verbal and written communication skills to all organization levels and clients.,Strong organizational skills; able to prioritize and manage complex processes/projects.,Ability to define problems, collect data, and draw valid conclusions.,Extensive experience with writing and managing investigations and risk assessments.,Previous experience as an auditor for internal and vendor audits.,Ability to be hands-on and detail oriented.

Bachelor's Degree (required), Master's Degree (preferred)