Quality Operations Director

Location: Buena, NJ

Reporting Relationships:  Multiple direct reports

Core Relationships:

  • Executive Management
  • Site Leadership
  • Group Quality US and Canada
  • Medical and Regulatory Affairs
  • Internal and External Customers
  • Production Operations
  • Supply Chain
  • Other company divisions as needed and required by position

Essential Responsibilities:

  • Manage the daily tasks associated with Quality Assurance Operations.
  • Support Operations by ensuring that all GMP documentation is accurate, complete, and prepared in a timely manner.
  • Provide leadership and ensure the operational success of quality functions with an emphasis on product quality, prevention, and continuous improvement.
  • Coach, mentor, train, and develop the Quality Operation’s staff.
  • Continuously evaluate effectiveness of quality functions to determine gaps or areas for improvement; convey results of assessments with appropriate actions to management.  Conform to expectations around metrics and KPIs that demonstrate the effectiveness, timeliness and the accuracy this Quality function.
  • Optimize systems and processes in order to put us in a state of permanent inspection readiness.
  • Ensure all Quality Operation’s activities are performed in compliance with local, state, federal, and international regulations and laws.
  • Collect and reporting of metrics and data to management per defined schedules
  • Continually and proactively enhances and streamlines the processes around CAPAs, change controls, deviations, customer complaints, annual product reviews, annual product reviews, and any controlled job aid.
  • Develops a vision for, and implements, innovative and approaches to organizational operations that continuously improve processes, outputs, and outcomes.
  • Ensure that all deviations are comprehensively investigated, the appropriate corrective and preventive actions are installed, and the investigation is closed out on time.
  • Participates, present and provide rationale for the Quality operations during periodic audits and regulatory inspection and customer visits/conference calls as required.
  • Other duties as assigned by management.

Qualifications:

  • Education: Bachelor’s degree in Chemistry, Engineering or other Physical Sciences
  • Minimum 8 – 10 years of experience in medical device and/or pharmaceutical QA or QC role
  • Working knowledge in the quality systems for the medical device and/or pharmaceutical industry
  • Working knowledge in FDA 21 CFR Parts 11, 210, 211 and 820 and ICH quality system requirements
  • Ability to work collaboratively in a professional and effective manner across all Teligent departments
  • Strong project management skills and problem-solving skills
  • Working knowledge of risk management
  • Strong leadership skills:
    • Ability to delegate and verify
    • Ability to manage and prioritize multiple tasks
    • Ability to guide and motivate personnel
    • Ability to plan and organize available resources and activities in-order to reach predefined goals
    • Awareness of inter-personnel relationships in the company
  • Experience in using computer programs (MS Word, Excel, and Access)
  • Strong verbal and written communication skills
  • Willingness to travel – up to 30% (Nationally and internationally)

Physical Demands/Factors:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

  • While performing the duties of this job, the employee is regularly required to talk or hear.
  • The employee frequently is required to stand; walk; use hands to handle or feel; and reach with hands and arms.
  • The employee is occasionally required to sit; climb or balance; and stoop, kneel, crouch or crawl.
  • Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
  • The employee must be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs.

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