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Celldex · 4 months ago

Director, Clinical Quality Assurance

US-CT-New Haven

Full-time

Onsite

Director/Executive

$177K/yr - $229K/yr

7+ years exp

Celldex is a clinical-stage biotechnology company dedicated to developing novel antibody-based treatments that improve the lives of patients with allergic, inflammatory, and autoimmune disorders. The Director, Clinical Quality Assurance will provide thorough knowledge of GCP Quality, strong leadership and clinical development experience to support Celldex’s expanding portfolio.

BiotechnologyHealth CareOncologyPharmaceutical

Responsibilities

Execute and oversee the clinical development oversight program across Clinical, Medical and Regulatory, and implement quality practices throughout clinical trial execution

Participate in the establishment, maintenance and improvement of the Clinical Quality Management System and associated practices

Determines, evaluates and investigates GCP Quality Events, adequacy of reporting and the potential impact on the study

Lead Celldex GCP Inspection Readiness activities

Provide leadership in GCP inspections performed by FDA and international regulatory agencies; also, audits performed by partners

Proactively identify analyses and leverage quality indicators and data for potential trends and risks to address and complete risk-based QA assessments and to support the implementation of associated risk mitigation strategies

Provides business-level leadership, fosters best practices, and mentors and consults on GCP compliance techniques across the development and operations organizations

Manages the process for documenting Process Deviations, Quality Issues, and CAPAs

Develop and support the issuance of Controlled Documents (e.g., Policy, SOPs, KPIs)

Provide suggestions for continuous quality improvement in GxP and, specifically, GCP

Maintain expert up-to-date knowledge on GCP legislation and relevant parts of GxP guidelines and practices and ensure that the information is distributed and acknowledged by relevant departments within Celldex

Responsible for QA review of key study documentation, SOPs, Vendor documentation, and relevant submission documentation

Qualification

GCP Quality ManagementClinical Quality LeadershipFDAICH GuidelinesQuality Risk ManagementGCP Audits ManagementOrganizedInterpersonal SkillsLeadership SkillsProblem-Solving AbilitiesDetail-OrientedAdaptability

Required

Bachelor's degree (or higher) in relevant field. Concentration in a scientific or health care field preferred

7-10 years of experience in the pharmaceutical or life sciences industry, with a strong focus on GCP Quality Management and clinical quality leadership roles

In-depth knowledge of FDA, EU and ICH guidelines for clinical research

Proven track record managing GCP audits, health authority inspections, and inspection readiness

Experience in Quality Risk Management for clinical trials and implementation of quality plans

Excellent interpersonal and communication skills with the ability to work in a fast-paced, collaborative environment

Strong leadership skills

Ability to work both independently and within a matrix organization

Strategic mindset with strong problem-solving abilities

Organized and detail-oriented, with excellent planning capabilities

Adaptability to changing priorities and deadlines