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Director, Product Quality (Aseptic Manufacturing)
Client: AbbVie
Location: Ireland
Job Category: Other
EU work permit required: Yes
Job Reference:
1313fbe5dc71
Job Views:
18
Posted:
03.03.2025
Expiry Date:
17.04.2025
Job Description:
*Please note that job level/grading may differ from country to country*
Purpose: Responsible for overall quality of AbbVie products which may include small molecule pharmaceuticals and/or biologics, combination products to ensure business objectives are met with regards to on-time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Scope of responsibility can also include business processes required to support new product introduction, product monitoring or post-market quality systems.
Responsibilities:
* Lead a team of Quality professionals responsible for assigned products and/or business processes required for on-market product support (e.g. quality monitoring, supplier quality, and/or post-marketing quality assurance).
* Core team member or lead of strategic programs; including Brand Teams, Product Transfers, Global Strategic Sourcing, Post-Market commitments, Due Diligence, Site Selection, and Approvals and Continuous Improvement.
* Develop and implement a global Product Quality Assurance strategy to support pharmaceutical, biologics, and combination products manufactured at AbbVie plants or third-party manufacturing (TPM) facilities.
* Support development of legal supply agreements, contracts, and letters of intent to ensure compliance and regulatory aspects are met for the products and services covered.
* Ensure business objectives are met regarding on-time delivery of product and budget while assuring compliance to local and divisional and corporate policies.
* Key decision maker on product quality and regulatory conformance issues; reviews and approves plant Quality Assurance performance reports and financial plans.
* Review and approve budgets; interface with internal audit teams to develop audit plans, review audit observations, and maintain a corrective action timetable.
* Monitor manufacturing operations for conformance with established procedures and requirements of corporate and governmental good manufacturing practices.
* Develop and execute global strategies related to product complaints management and stability assessment for all products globally.
Qualifications:
* Graduate Degree in Life Science or other technical discipline required.
* 15+ years of total combined relevant experience; at least 2 years Plant experience; at least 5 years in Operations, Research and Development or Technical experience.
* Expert knowledge and a comprehensive understanding of biological and/or pharmaceutical technologies.
* Capable of understanding and overcoming differing cultural and language obstacles to provide solutions that satisfy both functional and local objectives.
* Capable of analyzing data facts and informed opinion to direct the developments of effective action plans.
* Credible working relationship with plants.
Key Stakeholders:
External Mfg. Business Relationships, Third Party Manufacturers Business Alliance, Operations or Commercial Brand Teams, Commercial, Global Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs, R&D, Regulatory agencies.
Additional Information:
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
* Salary range may vary by location (U.S. and OUS).
* The compensation range described is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting.
* We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
* This job is eligible to participate in our short-term incentive programs.
* This job is eligible to participate in our long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
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