Associate Director QA

Position: Associate Director, Quality and Primary QP

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 reports 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, 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)

- In the case of investigational medicinal products manufactured in the Member State concerned, that each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use (2), the product specification file and the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
- In the case of investigational medicinal products manufactured in a third country, that each production batch has been manufactured and checked in accordance with standards of good manufacturing practice at least equivalent to those laid down in Commission Directive 91/356/EEC, in accordance with the product specification file, and that each production batch has been checked in accordance with the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
- In the case of an investigational medicinal product which is a comparator product from a third country, and which has a marketing authorization, where the documentation certifying that each production batch has been manufactured in conditions at least equivalent to the standards of good manufacturing practice referred to above cannot be obtained, that each production batch has undergone all relevant analyses, tests or checks necessary to confirm its quality in accordance with the information notified pursuant to Article 9(2) of Directive 2001/20/EC.
- Certify in a register that each production batch satisfies above mentioned provisions.

Education & Knowledge:

- University Degree in Pharmacy
- OR University Degree in a Science related discipline together with a post graduate course, which together with the primary qualification, satisfies the educational requirements as defined in Directive 2001/83/EC
- Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering principles and validation. Knowledge of applicable regulatory requirements

Experience:

- Relevant Experience working in the pharmaceutical or Biotechnology Industry over a minimum of 10 years

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