Associate Director QA

Overview The Primary QP role involves acting as the main Qualified Person (QP) on the Amgen Technology Ireland (ATI) manufacturing license. This position provides scientific, quality, compliance, and patient-centered support to the ATI manufacturing site. It includes supporting daily Quality activities related to technical issues with Amgen products and material suppliers, adhering to all applicable GxP standards.
Management This role includes managing the ATI QP team, and also involves managing projects within the Quality team and reporting to the Director of Quality Operations.
Essential Functions Responsibilities include, but are not limited to:
Serving as the primary QP at ATI for aseptically manufactured, parenteral products
Offering advice, guidance, and support to Amgen QPs and other functions based on past experiences and knowledge
Coaching and mentoring quality colleagues to develop problem-solving, decision-making, and critical-thinking skills
Evaluating multiple data sources and perspectives to accurately characterize problems and opportunities; solving complex problems with little precedent
Aligning views and reaching decisions by bringing together stakeholders with divergent views
Contributing to Product Quality Technical Agreements within the Quality Department as needed
Supporting inspection readiness, including developing playbooks and reviewing responses to GMP inspections
Providing technical support for successful outcomes of all regulatory inspections
Conducting vendor audits and site visits as required
Overseeing the evaluation of quality and distribution complaints
Leading projects and improvement efforts, including product launches
Maintaining close contact and familiarity with Amgen Quality systems and programs used at other Amgen sites
Acting as the primary liaison to HPRA
Required Knowledge, Skills, and Abilities Highly organized with good time management and prioritization skills
Critical thinking and evaluation of process problems
Excellent verbal and written communication skills, with the ability to communicate with a diverse audience
Patient and results-focused
Good leadership skills and highly motivated
Collaborative team player
Strong work ethic with a flexible and adaptable approach
Thorough understanding of Quality Systems and cGMPs
Interpersonal and professional skills to interact at all levels, including senior executives, contractors, and colleagues
Experience interfacing with regulatory bodies
Specific Responsibilities (Directive 2001/83/EC, Article 51) In the case of medicinal product manufactured within EU member states, ensure that each batch of medicinal product has been manufactured and checked in compliance with the laws in force in that member state and in accordance with the requirements of the marketing authorisation.
In the case of medicinal products coming from third countries, irrespective of whether the product has been manufactured in the Community, ensure that each production batch has undergone in a Member State a full qualitative analysis, a quantitative analysis of at least all the active substances and all the other tests or checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorization.
In the case of medicinal products intended to be placed on the market in the European Union, ensure that safety features have been affixed on the packaging.
Certify in a register or equivalent document that each production batch has been manufactured and checked in compliance with laws in force in Ireland, is in accordance with the requirements of the marketing authorization and with EU Good Manufacturing Practice (GMP).
Ensure batches of medicinal products are distributed as per the Manufacturing Importation Authorisation and EU Good distribution Practice (GDP) as per Directive 2001/83/EC and guidance 2013/C 343/01.
Investigational Medicinal Products QP (Directive 91/356/EEC and Directive 2001/20/EC) For investigational medicinal products manufactured in the Member State concerned, ensure that each batch has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC and Directive 2001/20/EC.
For investigational medicinal products manufactured in a third country, ensure each production batch is manufactured and checked in accordance with GMP standards at least equivalent to Directive 91/356/EEC, in accordance with the product specification file, and the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
For an investigational medicinal product which is a comparator product from a third country with a marketing authorization, ensure documentation certifying that production batches meet GMP, or that each batch has undergone all relevant analyses, tests or checks as per Article 9(2).
Certify in a register that each production batch satisfies the above provisions.
Education & Knowledge University Degree in Pharmacy
OR University Degree in a Science-related discipline with a post graduate course that satisfies the educational requirements as defined in Directive 2001/83/EC
Knowledge of GMP manufacturing processes, warehousing, supply chain, equipment engineering principles and validation; knowledge of applicable regulatory requirements
Experience Relevant experience in the pharmaceutical or biotechnology industry for a minimum of 10 years

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