QA Director - ADL2 - Drug Product Operations

QA Director – ADL2 Drug Product Operations

Join Amgen’s Mission of Serving Patients

What if you could join a company where every challenge is an opportunity to excel, and every opportunity is seized to make a lasting impact on the lives of patients?  What if you could do this at an established facility who is expanding providing you with the opportunity to learn and develop self, whilst hiring and developing a team as we embark on an exciting journey of constructing and qualifying a new aseptic syringe manufacturing  facility?   You can!

Joining Amgen means becoming part of a community that is passionate about transforming the promise of science and biotechnology into therapies that have the power to restore health and save lives. It's an opportunity to work alongside the brightest minds in the industry, fueled by our diverse culture, in an environment that fosters innovation, encourages professional growth, and values the unique contributions of each team member.

Amgen's mission of serving patients has driven a recognition of Amgen as a world leader in biotechnology, earning accolades for its innovative approach to healthcare and its commitment to improving lives. With a history of pioneering protein-based medicines we pride ourselves on our ability to bring vital medicines to patients around the world who need them.  Our culture is a tapestry woven from the diverse threads of its workforce, each thread strengthening the fabric of Amgen's identity. Here, every voice is heard, every contribution valued, and every individual empowered to make a difference. It is a place where the spirit of science and the passion for progress come together to create a brighter, healthier future for all.

QA Director – ADL2 Drug Product Operations

Reporting to the Executive Director of Quality/Quality Site Head, we are seeking an accomplished and driven Senior Quality Professional to assume the role of QA Director and Quality Leadership team member. Working with a cross-functional team including manufacturing, engineering, Process Development, Supply Chain, Regulatory Affairs etc., you will be responsible for all aspects of quality assurance and provide quality oversight to the design, construction, qualification and operationalisation of a new facility within the established ADL site, in Dublin. 

You will establish, lead, direct and inspire a Quality function for our new facility and will be a key member of the Quality Leadership and Operations teams at ADL.  In this pivotal role, you will ensure that the design, construction, qualification/validation and operationalization of a new aseptic manufacturing facility is in line with current Good Manufacturing Practices cGMP and other relevant regulations and specifications.  As part of the project leadership and Quality Leadership team, you will contribute to the quality and project strategy development and deployment and provide quality direction, consultation and oversight to this key new project and operation. 

This role is pivotal in ensuring that quality standards are met and maintained throughout all phases of commissioning/qualification and for the successful on time delivery of the project, including facility licensure and operationalization. 

The role will have primary responsibility for the development, implementation & maintenance of commercial quality assurance strategies including strategies associated with new product and/or process Introductions.  This role ensures that the quality strategy is implemented and that there is continuous drive to improve product and process quality, whilst advancing our strong quality and DI&B culture at ADL.

This position requires demonstration of strong collaboration, management and leadership skills along with advanced communication and analytical skills and requires detailed knowledge of GMP guidelines, including aseptic processing and practices

Key responsibilities include:

• Establishing strategies and objectives throughout the quality organisation. This requires the application of influencing and negotiation skills while engaging site, network and stakeholder teams to own and manage Quality.
• Supporting and leading the project and operational resource planning, onboarding and training for a new Syringe Drug Product aseptic Manufacturing facility.
• Establishment, development, leadership and mentoring of a Quality Assurance team who will challenge current procedures and business assumptions by identifying and implementing next generation Quality methodologies and tools to enable business excellence, cost reduction and enhanced compliance.
• Continuous improvement and championing quality culture and DI&B initiatives
• Collaborating extensively with key internal and external stake holders (e.g., Mfg., Quality, Supply Chain, Engineering, PD, Reg. Affairs, and Industry leaders) to guide the implementation of new regulatory guidance / requirements.
• Providing advice to management based on quality assurance and compliance matters whilst navigating global regulations.  The QA Director will interpret and implement regulations into an operational setting. 
• Accountable for all interpretations of GMP.  The appropriate implementation of policy and procedures related to GMP with a patient focused and a quality first mindset.
• Defining framework for department objectives, project and operation schedules, processes, and budgets.
• Key responsibility for regulatory filing review and inspection preparedness and for undertaking and interacting with regulatory agencies, partners and corporate functions during site inspections and post-inspection response processes.  
• Other duties and responsibilities that may be defined in line with quality business objectives. 

Basic Qualifications:

• Degree educated with significant relevant experience.
• Strong leadership skills with significant managerial experience directly managing people, teams, projects, and programs.
• Solid understanding and knowledge of cGMPs, with demonstrated competencies in aseptic manufacturing.
• Awareness and understanding of quality and regulatory industry trends, policies, and guidelines.
• Considerable experience in biotechnology aseptic processing and execution of cross functional, complex technical projects
• Excellent communication and people skills with a proven ability to work with and influence executive management.
• Has the breadth of experience across disciplines to understand the aspects of technology transfer to ask the right questions and challenge appropriately

Preferred Qualifications:

• B.Sc. in Science, Engineering or equivalent with additional qualifications (Masters /PhD)
• Considerable experience in transformational change programmes.
• Experience in the development and rolling out of effective training programmes.
• Knowledge of development of commercial processes including filings
• Strong technical skills related to process improvement.
• Proven track record of advancement in an established, high performing organization
• Proven skills in building and maintaining productive relationships with organizational partners such process development, manufacturing, quality, and regulatory affairs.
• Excellent project management skills with the ability to lead effectively in a highly matrixed organization.
• Qualified Person eligible