Quality Assurance Systems Lead

2 weeks ago

New Brunswick, New Jersey, United States Synectics Inc Full time
Job Overview

The Quality Assurance Systems Lead plays a pivotal role in establishing, supporting, and evaluating the efficiency of Quality Systems and Training within the Global External Manufacturing (ExM) sector.

Key Responsibilities:

  • Serve as the Local Process Owner for various Quality Systems utilized in Global External Manufacturing.
  • Foster and maintain effective communication and relationships with Global Process Owners and Leads regarding pertinent systems.
  • Represent ExM at Global Community of Practice meetings, ensuring stakeholder input is collected and relayed back to the Global Network.
  • Oversee all aspects of the process, including relevant procedures, training materials, SharePoint content, and applicable metrics.
  • Demonstrate technical expertise in processes, identifying risks and weaknesses within the system.
  • Ensure compliance with Regulatory requirements, Health Authority expectations, and global procedures.
  • Conduct regular reviews of processes, analyzing trends and metrics to provide actionable feedback to the Quality management team.
  • Address relevant process issues, discussing trends and exceptions at External Manufacturing Quality Councils.
  • Develop and implement proactive continuous improvement strategies, such as Value Stream Mapping and regulatory surveillance.
  • Manage processes including Deviation Investigations, CAPA, Complaints, Change Control, Quality Risk Management, Documentation, Training, Audits, and Inspections.
  • Provide daily support to ExM Operations regarding Quality Systems to achieve business objectives.
  • Process Customer Complaint records and escalate expedited complaints as necessary.
  • Assist in deviation investigations, CAPAs, and change controls.
  • Participate in Virtual Plant Team meetings and support risk assessment and mitigation plans for Contract Manufacturing Organizations.
  • Track CMO Health Authority inspection observations and CAPAs, escalating emerging trends or issues to relevant teams.
  • Collect and report Quality data and metrics for management review and organizational forums.
  • Utilize data analysis skills to enhance existing tools for improving quality system processes.
  • Compile statistical data for reports, ensuring database accuracy and creating management reports.
  • Lead coordination of work related to complaints, change control, deviation, CAPA, and document management.
  • Author, review, and approve Quality Management System documents, processing them in the electronic document management system.
  • Engage in Permanent Inspection Readiness activities and maintain the Quality Risk Register for ExM.
  • Monitor periodic reviews of Quality Systems documents and manage record-keeping systems.
  • Act as the ExM Quality Systems representative on various projects.
  • Support the scheduling and execution of self-inspection audits and participate in Quality Council meetings.
  • Identify and implement continuous improvement opportunities for Quality Systems processes.
  • Provide training for Quality Systems processes as required.

Qualifications:

  • A degree in Chemistry, Engineering, Biotechnology, or a related field.
  • Experience in managing product complaints, change control, and documentation within the pharmaceutical or medical industry.
  • A minimum of four years in a pharmaceutical Quality-related role, ideally within a Quality Systems team.
  • Strong knowledge of GxP regulations in the EU, US, and other global markets.
  • Experience leading or participating in project teams.
  • Experience in a GxP Manufacturing environment.
  • Ability to work independently with a positive attitude and high productivity.
  • Detail-oriented with excellent verbal and written communication skills.
  • Adaptable to fast-paced environments with dynamic timelines.
  • Strong interpersonal skills and ability to collaborate across diverse functional groups.
  • Proficient in Microsoft Office programs, including OneNote and SharePoint.
  • Fluent in English.
  • Preferred experience with infinity/Veeva Vault.

Benefits:

Healthcare Insurance: Eligible employees and their dependents receive healthcare coverage through BlueCross BlueShield of Illinois.

Dental Insurance: Employees and their dependents can enroll in a dental plan through MetLife.

Vision Insurance: Vision insurance is provided through VSP for eligible employees and their dependents.

401(k) Plan: Employees aged 21 and older can participate in the Synectics Inc. Investment Savings Retirement Plan.

Technical Certification Bonus: Employees may receive a bonus for approved professional certifications related to their position.

Synectics is an equal opportunity employer.

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