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Quality Director, Supply Chain Systems & Programs

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Dublin, County Dublin

  1. Operations
  2. Quality Assurance
  1. Full-time
R00107125

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on XFacebookInstagramYouTube and LinkedIn.


Job Description

We are currently looking for a Quality Director to join global team in Dublin. This person will have Ssrategic responsibility for the development of the Global Supply Chain Quality Systems & Programs including governance and process support via Abbvie’s center of excellence. This role will drive strategy development and deployment for distribution quality, including the development of corporate standards in GDP and Distributor/Customer Engagement. Proactively driving and engaging in mechanisms for maintaining, benchmarking and enhancing distribution oversight, governance and improvement programs. This position requires a thorough knowledge of international pharmaceutical distribution practices and is accountable for developing a proactive compliance plan to ensure regulatory compliance of distribution activities. This includes being up to date on all global regulatory requirements and development action plans to anticipate changes and take corrective actions to ensure compliance and assurance of our global supply chain to ensure that there is no disruption to our products on the market.

  • Strategic management of the Global Quality systems and programs for Supply Chain Operations as part of the Global Quality system, compliant to relevant GxP’s, Medical Device directives and the relevant in-country local legislation and MAH requirements.
  • Drive innovation through the implementation of tools and programs via the Abbvie QMS that create value and ensure robust governance, oversight and compliance with latest regulation and technology.
  • Provide quality and regulatory guidance and support for Abbvie Product Development Science and teams in relation to distribution, storage and stability requirements maintaining robust distribution lanes.
  • Provide quality and regulatory compliance review and approvals of product development technical services study protocols and reports in support of submissions for new product and existing product and submission and regulatory questions as it relates to distribution including, Storage and containment and lane qualification and verification.
  • Ensure that Supply Chain’s distribution network is well understood and mapped and, changes are communicated to the relevant stakeholders for awareness and appropriate assessment.
  • Establish and maintain quality risk assessments to ensure that marketed products and their related systems are of an acceptable level of compliance to ensure product is distributed to patient as intended minimizing the potential for product recalls and market action.
  • Assure timely notification of significant issues and execution of necessary regulatory actions.
  • Strategic development of key partnerships with external vendor and integration into AbbVie global quality management systems including packaging and service providers.
  • Develop and improve transportation risk & compliance from manufacturing to end user.

Qualifications

  • The equivalent of 4 years college education in a medical/scientific related field. Education needs must meet QP requirements.
  • At least 10 years’ experience in quality related or production in the pharmaceutical or medical device industry.
  • Preferable experience within the Supply Chain in the area of distribution or transportation.
  • Supervisory management and proven experience managing & developing multi-site, multi country and multi-functional teams.

Please note, salary and grade will vary depending on location of the role.


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.