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Quality Assurance Validation Manager

Location : Mahwah NJ US 07430
Job Type : Direct
Reference Code : 20557-AB1
Compensation : 120000.00 - 150000.00 USD/YEAR
Start Date : 04/27/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Science or Engineering
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Quality Assurance Validation Manager to manage the development and implementation of QA validation activities and their continuous improvement initiatives at a biotech manufacturing facility in Northern NJ.

  • Ensure that quality standards are enforced.

  • Build, enhance, harmonize, and manage quality assurance validation across additional sites. Find solutions and coordinate change initiatives.

  • Provide leadership and direction to oversee and manage all validation activities by planning and allocating resources to ensure goals are met.

  • Work closely with quality training staff to develop training curriculum driven by compliance standards.

  • Coordinate investigations and closures of deviations with root cause analysis.

  • Ensure appropriate Corrective and Preventive Actions (CAPA) are initiated and implemented.

  • Manage end-to-end delivery of quality document assuring compliance of company's quality standards.

  • Review and approve GMP documents such as investigation reports, CAPA, validation protocols and reports, SOPs, change controls, etc.

  • Review and propose changes to quality agreements.

  • Participates in ongoing quality system improvement programs and initiatives.

  • Establish Quality Validation KPI Reporting and Continuous Improvement metrics.

  • Participate in internal audits, regulatory agencies, and client audits.

  • Provide technical information during tech transfer activities to ensure all quality requirements are met according to current industry standards.

  • Represent Quality Compliance in internal and external audits which may include interaction with regulatory health authorities and clients

  • Review and approve validation protocols, reports, investigation reports, assignment of CAPA's, SOP development and revisions.

  • Develop and revise policies and procedures, as well as, support operational excellence initiatives.

Required Qualifications :

  • BS Science or Engineering

  • Minimum 5 years of experience executing, developing, and administrating GMP quality programs in clinical and commercial manufacturing for biotech or pharmaceutical.

  • Minimum 3 years of recent supervisory experience, organizing and leading teams.

  • Knowledge of FDA and EMEA regulation.

  • Working knowledge of root cause analysis.

  • Knowledge of quality system applications, including the use of electronic system for training, deviation, CAPA management etc.

  • Experience in authoring, reviewing, and approving GMP documents.

  • Experience in participating in health authority inspection and client audits.

  • Up to a 20% bonus on top of salary is possible.

Contact: Allan Berman

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