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Manager, Quality Complaints

Company: Allergan
Location: Waco
Posted on: January 14, 2019

Job Description:

Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma.?Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective?therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.?Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. ?Power your future & join our bold team.?Position OverviewThe Manager, Complaints Dept., leads, coordinates activities and provides oversight of customer complaints at the Waco facility. ?Main Areas of Responsibilities

  • Lead the Customer Complaint response group in Waco facility.
  • Define priorities and responsibilities among his team.
  • Oversees customer complaints and ensures emerging issues are elevated appropriately to protect patient safety
  • Evaluate and approve consumer complaints by preparing written investigations, evaluations, and responses to customer complaints to identify root causes, develop mitigation, and remediation plans.
  • Ensure that complaint trends and statistical evaluations relating to customer complaints from sources (e.g., the complaint database, non-conformances, and preventative maintenance data) are performed according to procedures and industry standards.
  • Evaluate preventative and proactive identification of variables to provide data for decisions and preventing customer complaints.
  • Collaborate with Production and Engineering to ensure regarding complaint trends and serve as the QA representative to implement corrective and preventative actions.
  • Serve as the QA liaison for Global Safety to initiate HHE?s.
  • Responsible to keep ongoing communications with different global and regional areas regarding complaint investigations, corrective, and preventative actions for customer complaints.
  • Serve as the QA representative on Validation and Technical Services projects as required to ensure aspects of Patient Safety are considered and addressed.
  • Generate appropriate CAPA?s and/or provide guidance regarding Quality Defects or Patient Safety
  • Support change control activities associated with processes and equipment regarding Quality Defects or Patient Safety? ?Incumbent has full authority to make decisions and/or take action that is required to carry out job duties.? Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, cGMP procedures, general business policies, requirements and objectives. The incumbent must be willing to take temporary assignments as required.Incumbent will work to ensure that the company is in compliance with all environmental, health and safety requirements and assure our business practices enhance the welfare of our customers, employees and the community in which we operate. The following listed requirements need to be met at a minimum level to be considered for the job:
    • Minimum B.S. Engineering, statistics, or sciences degree from an accredited institution; Graduate degree is preferred
    • CQE is highly desirable
    • Five (5) years minimum experience with a minimum of three (3) years working in relevant areas such in a Manufacturing or Quality.
    • Experience in Pharmaceutical and/ or Medical Device industry preferred.?
    • Previous experience leading Customer Complaint system.
    • Strong user of Excel and Statistical programs like Minitab
    • Prefer experience in a GMP regulated environment
    • Prefer experience in an aseptic environment
    • Demonstrated ability to apply analytical and statistical methods
    • Critical thinking, problem solving abilities, strong detail orientation
    • Ability to organize, develop and prepare written investigations
    • Broad understanding of Quality Engineering activities
    • Ability to interface with all levels of personnel
    • Demonstrate leadership and ability to delegate and prioritize tasks.

      Keywords: Allergan, Waco , Manager, Quality Complaints, Executive , Waco, Texas

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