West-Ward Pharmaceuticals

  • SUPV QUALITY COMPLIANCE

    Job Location US-NJ-Cherry Hill
    Posted Date 1 week ago(4/13/2018 11:22 AM)
    Job ID
    2018-4457
    Job Function
    Quality
    Shift
    1st
  • Overview

    Supervises all activities related to providing required documentation and all updates of all documentation systems. Ensures that projects are completed on schedule, following established procedures and schedules. Lead and participate on cross-divisional/functional product development, special project and training teams. Able and willing to perform all activities associated with the QA Compliance Group including word processing to support operations and other departments.

    Responsibilities

    1. Supervise the functional activities and employees associated with the creation, revision, issuance, review and storage of controlled quality records in compliance with GDP's.
    2. Assist other areas in successfully meeting objectives and milestones.
    3. Maintain the technical and non-technical documentation change system.
    4. Handle internal and external customer related issues.
    5. Interpret and enforce all documentation standards, policies, and operating procedures.
    6. Interface with development and technical support groups in the management of information.
    7. Assist in budget preparation for the department.
    8. Provide training, guidance and coaching in the areas of responsibility for direct reports, internal and external customers.
    9. Perform and maintain performance reviews with direct reports.
    10. Suggest other options to improve efficiency, reduce operating cost and assist with moving products to market in a timely manner
    11. Perform the responsibilities of the Manager on an as needed basis.
    12. Assist with vendor audits/assessments, training and provides ongoing feedback related to quality issues.
    13. Perform any job responsibility of direct reports, as needed.

    Qualifications

    1. Collaboration and influencing skills.
    2. Excellent interpersonal skills.
    3. Ability to resolve conflict in a positive, proactive manner.
    4. Excellent project management skills.
    5. Frequent interaction with equivalent level managers and customers concerning projects, operational decisions, scheduling requirements or contractual clarification.
    6. Lead cross divisional cross functional teams.
    7. Working knowledge of FDA Regulations.

    A minimum of bachelor degree in science related field. Minimum of 6-8 years of pharmaceutical industry experience is required. Experience in QA/QC is desirable. Supervisory experience preferred.

     

    Understanding of cGMPs and regulatory requirements, company procedures and policies. Excellent interpersonal, communication and technical writing skills.

    Experience leading cross-functional and cross-divisional teams.

    In-depth knowledge of product/document management.

    Must be capable of operating in a computing environment that consists of Windows, Microsoft Office tools, LIMS, SAP, SmartSolve.

    Must be self-motivated, have good interpersonal skills and capable of analyzing and solving complex problems.

    Requires excellent formal and informal communications skills.

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