The Manager, Quality-Distribution will work closely with the rest of the Quality–Distribution team to ensure Good Distribution Practices (GDP) compliance as it relates to the supply of drug products from client, to end customers via Affiliates, commercial distributors and Access Operations & Emerging Markets (AOEM) distributors.
• Support initial due diligence checks of potential new AOEM distributors
• Provide routine support to partners in the area of GDP compliance
• Generate and maintain Quality Agreements between client and Affiliates/ 3rd party Distributors
• Documentation review & approval for in-market GMP/GDP activities performed by 3rd parties
• Generate and update controlled documents (e.g., procedures, forms, reports) as needed, to ensure compliance with applicable quality objectives and regulatory requirements.
• Perform & Support gap analysis and risk assessments on processes within Cork and Dublin, Affiliates and Distributors or wherever they may be required, to evaluate compliance to relevant GDP regulations/guidelines & implement/support the implementation of corrective actions
• Lead and/or participate in small cross-functional working groups to deliver processes & procedures under the Corporate Support Model initiative for the EU and ROW Affiliates
• Maintains programs and processes to ensure high quality products delivered to customers and compliance with current Good Distribution Practices (GDPs).
• Collaborate cross-functionally with local and global colleagues (Supply Chain, Commercial Operations, Corporate Quality, Customer Service) to identify and implement process improvements in distribution of raw materials and finished products
• Participate in developing & delivering training as it pertains to GDP
• Participate in internal and external compliance audits as required, including audits of potential new distributors and on-site visits.
• Lead or co-ordinate investigations and corrective and preventative action recommendations related to product supply chain
• Participate in inter-site global projects in the area of distribution of APIs and Finished Products
• Support regulatory inspections of (Cork and Dublin facilities) as required
• Support the annual product recall challenge & participate in product recall, as required
Knowledge, Experience & Skills:
• Demonstrates proficiency in Good Distribution Practices (GDP) and Good Manufacturing Practices (GMP)
• Familiar with the concepts of supply chain dynamics between freight forwarders, carriers and handlers related to the supply and delivery of pharmaceutical materials.
• Understands the time & temperature sensitivity of pharmaceutical material and concepts related to product stability, product labelling and risk management.
• Demonstrates excellent knowledge of regulations and guidelines associated with distribution supply chain of medicinal products and APIs
• Demonstrates proficiency in application of QA principles, concepts, industry practices, and standards.
• Demonstrates understanding of international quality systems regulations to adopt best in class systems/processes
• Demonstrates working knowledge with good proficiency in Microsoft Office applications.
• Working knowledge of Risk Management tools (e.g., Failure Mode Effects Analysis (FMEA) is beneficial.
• Knowledge of Six Sigma, Define-Measure-Analyse-Improve-Control (DMAIC) methodology, performance measures and quality improvement statistical methods is beneficial.
Typical Educational Experience & Competencies
• 3+ years of relevant experience in the pharmaceutical industry and a BS or BA.
• Ability to work on own initiative as well as display strong teamwork skills
• Eager to learn and develop within the role and the organisation
• Demonstrates excellent verbal communication, technical writing and interpersonal skills.
• Demonstrates ability to effectively manage multiple projects/priorities and to work to tight deadlines.
• Demonstrates clear personal responsibility for own work, in terms of both the quality of the work and the manner in which it is performed
• Ability to initiate and support change and respond to change requirements by continually striving to improve working processes and systems, consistent with the organisational strategy
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