Director, Quality Assurance

Overview

The Director, Quality Assurance at Celldex Therapeutics will lead and oversee all GMP Quality Assurance operations for the Fall River site, ensuring compliance with FDA, cGMP, and international regulatory requirements across manufacturing, testing, product disposition, training, audits, and quality systems. This role calls for an experienced biotech quality leader with a strong background in managing QA teams, improving quality processes, overseeing compliance programs and metrics, and working cross-functionally to support the successful production and release of biologic products.

Responsibilities

• Oversee and maintain Quality Assurance systems: Deviations, CAPA, Change Control, OOS, raw material and product disposition, vendor qualification, the nonconformance program, training, equipment maintenance and validation and related activities. Ensure adherence to QA systems, policies, programs and procedures for manufacture, testing and release of product at Celldex Fall River. Oversee Material Review Board, Label Control and Product Complaint programs.
• Direct the sites GMP Quality Assurance (QA) Department and oversee the QA Documentation team
• Evaluate complex site-based, CMO and CTL issues and provide compliance guidance as needed
• Responsible for Cell bank, formulated drug substance and drug product disposition
• Develop and oversee a competency-based QA training program including but not limited to employee QS training, cGMP, Document Control, deviation reporting and documentation guidelines; assist other area managers in the development of competency-based department specific training programs; oversee all training documentation for the facility including employee training files and training modules
• Trend and report QA Metrics to executive team
• Ensure site preparation for and support external audits.
• Originate or implement improvements to Quality procedures and databases as necessary. Track and evaluate Quality metrics
• Form strong relationships with Manufacturing, Quality Control, Facilities, Materials Management and Validation HODs and teams in support of operation.

Qualifications

• Bachelor Science or MS degree in biological sciences or related discipline Bachelor Science or MS degree in biological sciences or related discipline
• 15+ years experience in a Quality Assurance (some Quality Control and Manufacturing experience also acceptable) preferably in the biologics/biotech industry
• 6+ years of previous management experience of Quality Assurance Personnel
• Extensive knowledge of governing body regulations
• Well-rounded QS experience, including product disposition
• EDMS and Medical Device experience highly desirable but not required.
• Strong knowledge of MS Word, and Excel
• Knowledge of FDA (CBER) regulations, European Directives, ICH guidelines, and cGMP regulations
• Excellent communication, management and technical writing skills
• Strong written and interpersonal communication skills
• The ability to take initiative, to maintain confidentiality, to meet deadlines, and to work independently and as part of a team

Compensation

The expected base salary range for this position is $176,659 to $229,427

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach