TAD PGS, Inc. has a job for you.


Job Details


Quality Systems Manager  West Caldwell, NJ  Posted: 5/23/2023
Job Description

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Position Type:

Associate - W2



We have an outstanding career opportunity for a Quality Systems Manager to join a leading Company located in the West Caldwell, NJ surrounding area.

The Quality Systems Manager will work within the Quality team and play a vital role in the creation and evaluation of all company Quality systems. The Key Objective of the Quality Systems Manager is to ensure that all company Production Quality systems meet and are delivering against all regulatory requirements. They will provide support for product assurance from design effort to initial product qualification followed by the first phase of production. They will interact with production and engineering personnel to set up production test requirements and new product qualifications. 

  • This position supports the daily QA departmental operations and assists the Director of Quality in ensuring compliance in all areas
  • The Quality Assurance Manager is responsible for supporting the Quality System in conjunction with client needs and requirements to ensure compliance with FDA CFR 110, 111, 117, 210 & 211 and customer-specific requirements
  • Provide Quality support for all new client management and managing all product launches and new product SKU's as well as all special projects
  • Train all required personnel to ensure a successful launch and production run
  • Assists in evaluating all new client and product prospects to determine specific registration, certification, and license requirements; this will be completed alongside the Director and/or QA Specialist
  • Must attend all new product meetings to be aware of all documentation and specific quality requirements; including but not limited to, Master Batch Record requirements, and revisions, packaging and shipping requirements, sampling requirements, validation requirements, or registration requirements
  • Develop and oversee all Stabilities and Validation activities; IQ/OQ/PQs for equipment, cleaning, or other special project protocols
  • Oversee the calibration process
  • Update and create Standard Operating for Quality Assurance-related activities
  • Effectively monitor and enforce compliance with the company's SOPs and cGMPs
  • Oversee the HACCP (Hazard Analysis and Critical Control Points) Program
  • PCQI Representative (Preventative Controls Qualified Individual)
  • Manage activities related to external labs and consultants
  • Review and approve lab reports and ensure consistency with MP standards
  • Responsible for environmental program cleaning validation and pathogen detection 
  • Perform Risk Assessment for new products and Annual Review for Environmental Monitoring Programs, Cleaning Validation, and Pathogen Detection Programs
  • Oversee the CAPA process with emphasis on the timely completion of tasks
  • Deliver and update reports related to KPIs
  • Oversee the Pest Control Programs, providing monthly updates of any inconsistencies
  • Provide administrative/technical support to the Director of Quality and the Quality Team
  • Assist with FDA and other regulatory agency inspections
  • Assist the QA Specialist in drafting and/or writing change controls, complaints, deviation, and investigation reports
  • Maintain an organized workplace
  • Perform other related duties as assigned

Basic Hiring Criteria:
  • Bachelors' degree in a scientific field is strongly preferred
  • Minimum 5 years of experience in a pharmaceutical and/or nutritional supplement industry 
  • Minimum 5 years in pharmaceuticals 
  • Minimum 2 years of experience in management or supervising a team

Desired Qualifications:
  • Knowledge of FDA CFR 210-211 cGMP regulations and guidelines and QA best practices
  • Experience working with Contract Packaging and/or Manufacturing Organizations is a must
  • Validation experience is strongly preferred
  • Experience with new product launches is strongly preferred
  • Excellent technical writing skills are a must
  • Demonstrated experience with Quality Systems
  • Must be self-motivated and able to work independently but maintain a team-focused attitude
  • Excellent attention to detail and follow-through and organizational skills
  • Ability to advocate a quality environment
  • Excellent verbal, written, and interpersonal communication skills
  • Advanced Excel skills
  • Ability to motivate and build strong relationships with internal team members as well as with clients, when required
  • Proactive thinker
  • Ability to identify potential issues beforehand and raise them to management with possible solutions
  • Verbal interactive communication skills

Job Requirements

Minimum Security Clearance:

No Clearance


TAD PGS, Inc. is a Global Fortune 500 company with worldwide revenue of over $27 billion and more than 50 years of government contracting experience. We specialize in supporting U.S. Government Agencies and their prime vendors by delivering a full range of recruitment and workforce solutions. As part of the Adecco family, we have access to over 2.5 million active candidates supporting hundreds of locations across North America. On any given day, we have more than 70,000 professionals working at client sites across the United States.

 VEVRAA Federal Contractor / Request Priority Protected Veteran Referrals / Equal Opportunity Employer / Veterans / Disabled
The Company will consider qualified applicants with arrest and conviction records.
To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit http://www.tadpgs.com/candidate-privacy/


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