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Celldex · 16 hours ago

Vice-President, Quality

Hampton, NJ

Full-time

Onsite

Director/Executive

$269K/yr - $349K/yr

15+ years exp

Celldex is a biotech company focused on quality management in the development and manufacturing of biologics. The Vice-President, Quality will lead quality assurance, quality control, and validation efforts to ensure compliance with GMP and GLP standards, while fostering a quality culture centered on patient safety and product quality.

BiotechnologyHealth CareOncologyPharmaceutical

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

Qualification

Quality Assurance (QA)Quality Control (QC)GMP knowledgeGLP knowledgeBiologics/biotech experienceFDA regulations knowledgeAnalytical testing oversightValidation programs expertiseInterpersonal skillsCommunication skillsCreative thinkingAttention to detail

Required

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