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