Celldex
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Vice-President, Quality
role at
Celldex
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
Compensation The expected base salary range for this position is $268,676 to $348,929. 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.
Seniority level Executive
Employment type Full‑time
Job function Quality Assurance
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.
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Vice-President, Quality
role at
Celldex
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
Compensation The expected base salary range for this position is $268,676 to $348,929. 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.
Seniority level Executive
Employment type Full‑time
Job function Quality Assurance
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.
#J-18808-Ljbffr