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Company Description

The Supply Chain QA Distribution Quality Manager (Manager, QA) is responsible for providing leadership to the Global SCQA Responsible Persons Team and ensures the integrity and compliance of our distribution and logistics operations and partners in alignment with national and international regulations.

This position is responsible for safeguarding patients against potential hazards resulting from poor distribution practices, through compliance to licensing provisions, operational performance, maintenance of the quality system, and deciding on the final disposition of returned, rejected, recalled, or falsified products.

The QA Manager primary responsibilities include: management of authorized activities, accuracy and quality of records, effective management of complaints, ensuring supplier and customers are approved, initiating quality event records, approving returns to saleable stock, and assuring that any additional requirements imposed on certain products by regulators are adhered to.

Job Description

  • 3rd Party Logistics and Distribution Center Operations Management: day to day first point of contact and support.
  • Acts as an internal local consultant on the principles of quality assurance and GDP.
  • Regularly conducts and participates in quality business reviews with partners and stakeholders.
  • Ensures operational audit readiness for 3PLs, company distribution and logistics operations.
  • Responsible for facility validations and qualifications for storage of AbbVie products.
  • Ensures that required licenses are available and current.
  • Ensures Customer Distributors are set-up and implemented.
  • Review Metrics with 3PLs and Distribution Centers (DCs) for trends and corrective actions
  • Lead quality event triage and exception investigations.
  • Responsible for corrective and preventative actions associated with events in the distribution and logistics network.
  • Responsible for 3rd party logistic (3PL) partner SOPs review and approval.
  • Responsible Quality Technical Agreement (QTA) review and approval.
  • Provide input to SCQA Management Review.
  • Managing of team of Responsible Persons and QA officers

Qualifications

  • University degree is required (Life Sciences, Pharmacy) or a course recognized as equivalent.
  • 3+ years’ experience in pharmaceutical industry and/or pharmaceutical distribution environment including supervisory or management experience and experience or certification as a Responsible Person.
  • Demonstrated experience managing a global professional quality organization.
  • Knowledge and experience of applicable regulations, quality systems, and principles of quality assurance.
  • Experience with Quality systems and Quality Assurance in an operational setting with demonstrated knowledge of techniques for assessing the quality of processes.
  • Knowledge of regulations, guidelines and standards related to manufacturing and distribution of medicinal products and medical devices.
  • Technical experience in the following areas is desired: logistics, materials management, production, engineering, computer science, quality control/assurance, and compliance/regulatory.
  • Proven process improvement and/or product development experience in an industrial setting with demonstration of effective communication, teamwork, problem solving, negotiations and conflict resolution skills.
  • Ability to interact successfully in a diverse global environment and with senior level management to effectively influence and manage change and proven capability to manage and implement change management programs.
  • Team player with focus on improvement and a strong drive for results, excellent helicopter view,
  • analytical skills and organizational skills.
  • Excellent written English communication skills (must).

Key Stakeholders:

  • Global Distribution and Logistics
  • Global Supply Chain Planning
  • Third Party Logistics providers
  • Manufacturing sites
  • TPM manufacturing sites
  • Affiliates and distributors
  • Relevant professional societies
  • Global MOH (Ministry of Health, FDA)
  • Local Staff
  • Consultants

Additional Information

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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Confirmed 22 hours ago. Posted a day ago.

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