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Quality Assurance Manager

Company: KORE1
Location: New Brunswick
Posted on: June 23, 2022

Job Description:

Reports to: VP of Quality# of Direct Reports: up to 10 (once fully staffed)Annual Bonus: 10%Work Schedule: 8 am - 5 pm, M-F *Pharmaceutical Industry experience requiredEssential Functions:

  • Act as the Subject matter expert on all FDA regulations and requirements as well as the advisor to the senior management team; in addition to acting as the liaison for all regulatory agencies
  • Spearhead the company's Quality Assurance functions while building a team of likeminded individuals
  • Demonstrate a strong partnership with cross-functional teams, mainly Operations and QC
  • Act as the "go to" for audits and inspections (including readiness), as appropriate.
  • Maintain SCM's compliance with cGMPs
  • Manage Out of Specification investigations reports
  • Review product and process deviations
  • Review New product set up
  • Participate in the evaluation, selection service providers
  • Provide GMP, ISO, GDP training to the team
  • Manage ISO 9001 certification for SCM
  • Manage Quality Documentation process
  • Negotiate and maintain vendor Quality Agreements
  • Provides guidance to peers regarding Quality and regulatory issues.
  • Prepares and reviews annual reports and supplements for marketed products.
  • Accountable for Raw Material Change control program
  • Support SCM's Vendor Management initiative
  • Supervises the identification and compilation of required documentation for submissions.
  • Function as the quality lead for any assigned projects; providing support to the Operation, Quality Assurance units as needed.
  • Write/review and update Standard Operating Procedures
  • Independently prepare and submit meeting requests and meeting packages, leading all company quality and regulatory meetings.
  • Provides expert opinion, advice, and recommendations to the organization regarding quality processes.
  • Problem-solve quality issues to preserve original timeline for various projects; track progress while being accountable for quality system deliverables.
  • Accountable for maintaining the organizations adherence to all relevant Quality requirements.
  • Perform other duties as required, interfacing with other departments, customers and external vendors as needed.
  • Help drive a LEAN culture by mentoring and creating training opportunities. Internal quality system audit and remediation skills required.
  • Collect data, analyze outputs, and determine corrective courses of action to promote safety, quality, and efficiency
  • Identify ways to eliminate waste in production processes.
  • Analyze and identify opportunities to reduce process variation, improve process capabilities and optimize process performance.
  • Work with management to identify new process improvement opportunities in the areas of quality, cost, performance, and preventive and predictive maintenance.
  • In-depth experience implementing Lean, 5S, Value Stream Map and KaizenRequirements:
    • Candidate must have a bachelor's degree from a four-year college, strong preference for a background in Chemistry
    • Minimum of 5 years' experience managing teams, building and managing a dynamic team
    • Minimum of 5 years' experience leading and managing Customer & Supplier Audits
    • Minimum of 5 years' experience leading and managing FDA/DEA/Regulatory inspection experience
    • Minimum of 5 years' experience in a GMP, GDP environment
    • Experienced in the investigation of OOS, Complaints, CAPAs, SCARs, Deviations
    • Experience in Change Control, Process Improvement, Lean, Project Management
    • LEAN Six Sigma Certification
    • ISO 9001:2015 Lead-Auditor Accreditation
    • GMP auditor
    • Board of Pharmacy Accreditation
    • Ability to read, analyze, and interpret common regulatory regulations, and legal documents.
    • Ability to respond to common inquiries or complaints from customers, regulatory agencies, or internal team members.
    • Ability to effectively present information and perform training to internal team members

Keywords: KORE1, New Brunswick , Quality Assurance Manager, Executive , New Brunswick, New Jersey

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