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Quality Systems Manager (Pharma-Change Control Process)

Lynkx Staffing

Quality Systems Manager (Pharma-Change Control Process)

Princeton, NJ
Full Time
Paid
  • Responsibilities

    Our Client is a fast-growing global specialty pharmaceutical firm that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four areas of unmet need: oncology, nephrology, immunology and CNS/movement disorders.

    The Quality Systems Change Control Manager is responsible for performance and/or oversight of the Quality Systems function for the North America region. The Manager will assure compliance with laws and regulations and in a manner consistent with best practices and applicable guidance.

    The Quality Systems Change Control Manager will be responsible for Change Control oversight, execution, and facilitation of the Regional Change Control Review Board. Other Quality Systems responsibilities are listed and will be secondary responsibilities if needed.

    Responsibilities include performance GxP and at third-party contractors related to quality management systems, document management and control, annual product reviews, and training.

    Quality Management Systems

    • Provide effective oversight of the Change Control process for the N. America Region including the Change Review Board.
    • Provide expertise and guidance for Change Control execution.
    • Support the implementation and management of the eQMS system including the Change Control module for the N. America region as needed.
    • Execute strategies for continual process improvement of quality systems as needed.
    • Assist/lead during regulatory inspections of facilities and GxP contractor sites.
    • Track performance of deviations, CAPA, Change controls, and report to department/regional management.
    • Develop and support internal quality management systems; e.g., systems for batch release and control, audits, policies and procedures, investigations and CAPAs, change controls, document management, and training management.
    • Schedule and manage the QA Orientation and on-boarding process for all new hires at Princeton/Bedminster locations.
    • Maintain regulated training records of SOPs/ Work Instructions. Create and manage training materials.
    • Track compliance with regulated training requirements for Development and Commercial Operations personnel at Princeton and Bedminster locations.
      – Manage training records for N. America region employees. Develop and maintain training curricula.
    • Participate in developing and revising SOPs.
    • Post all new procedures after performing Quality checks facilitate review/approval process and assign effective dates.
    • Track document revision due dates, notify authors, issue draft documents for revision, and track completion. Notify management of any delays.
    • Manage document files, including SOPs, validation documentation, and manufacturing documentation.
    • Act as Subject Matter Expert for systems validation, change control and periodic review.
    • Act as business administrator/super user.
    • Maintain and track all GxP records for Development and Commercial Operations on-site and/or off-site contract storage facilities.
    • Compile required information from both internal and external stakeholders to complete Annual Product Review reports for all N. America products.
    • Perform additional activities related to the Quality function as needed.
    • Benchmark other quality and industry organizations to remain current with industry regulations and compliance trends.
    • Support budget oversight for functional area.

    REUIREMENTS

    • Bachelor’s Degree in a life science-related discipline
    • 5+ years of GxP related experience in the Pharmaceutical or Bio-pharmaceutical industry.
    • Prior experience in the following areas:
      – Change Control, Deviations, and CAPA
      – Training
      – Document Management
      – Quality Metrics
      – VEEVA or other electronic quality management systems
      – Learning Management Systems
      – Document Management Systems
      – System Administration of a 21CFR Part 11 Compliant System
      – Computer System Validation
      – Operational Excellence, including Lean and Six Sigma methodologies
    • Experience in demonstrating strong interpersonal skills, a flexible, collaborative and team-oriented approach to problem solving, and an ability to work in a fast-paced, rapidly changing environment.
    • Ability to exercise strong business judgment.
    • Ability to interact collaboratively across diverse functions, operate independently and build strong networks throughout the corporate organization.
    • Ability to prioritize and align the organization with goals and objectives, and ensure rigor in operational excellence.
    • Ability to lead high performing teams.
    • Attention to detail for documentation and processes is essential.