Vice-President, Quality

Role Summary

The Vice-President, Quality serves as the strategic leader and operational manager to direct, oversee, and manage quality activities specific to GMP and GLP. This role will be a visionary champion for building the right quality culture for Celldex, with focus on patient safety, product quality and continuous improvement.

Responsibilities

• Provide strategic direction for Quality Assurance (QA), Quality Control (QC) and Validation to ensure compliance across all in-house and contract manufacturing
• Build a scalable corporate quality system to support late-stage development, regulatory inspections, and commercial readiness
• Build effective cross functional partnership with Manufacturing, Clinical Development, Regulatory, and Commercial teams, to ensure quality is built into every stage of clinical and commercial processes.
• Oversee Contract Development Manufacturing Organization (CDMO) quality management, including audits, change controls, complaints, supplier corrective actions, and vendor qualification.
• Responsible for the QA, QC & Validation departments overseeing Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) operations in manufacturing and testing facilities.
• Direct the development, improvement, validation, and troubleshooting for QC analytical testing and raw material release, batch release, and environmental monitoring
• Drive the development of a Commercial Quality System in collaboration with relevant peers
• Oversee internal auditing including internal inspection readiness for GMP and GLP preapproval inspections
• Coordinate inspection and audit follow-up and corrective action planning and ensure facility inspection readiness
• Direct the company's internal and external quality system audits
• Coordinate and recommend improvement initiatives and quality policy
• Remain current in and manage the Quality Organization in accordance with the evolving regulatory environment as it relates to our business

Qualifications

• Graduate degree (MA/MS, PhD, J.D., Pharm.D. or equivalent) in basic or applied science (Chemistry, Biological Sciences, Pharmacology or Pharmaceutical Science or closely related areas)
• 15+ years of experience in a Quality Department in the biologics/biotech industry with a minimum of 10+ years managing QA/QC operations in a development and manufacturing environment
• Significant experience in biologic drug manufacturing as well as drug delivery required
• Knowledge of Combination Product/Device QA is required
• Ability to think creatively while taking a broad systemic view and maintaining a meticulous eye for detail
• Strong management, interpersonal and communication skills
• Advanced knowledge in areas of pharmaceutical industry-related practices, 21 CFR Part II and GMPs
• Experience with current GMP's, vendor audits, FDA regulations, quality system regulations, and team development
• Knowledge of FDA regulations, European Directives, ICH guidelines, and cGMP regulations
• FDA/regulatory inspection experience required
• Hands-on expertise with validation programs, analytical testing oversight and quality management systems
• Knowledge of/Experience in GCP QA strategy and GCP QA operations a plus