QA Director - ADL2 Drug Product Operations
We are seeking an accomplished and driven Senior Quality Professional to assume the role of QA Director and Quality Leadership team member.
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About Amgen
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.
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.
Job Summary
The QA Director will lead 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.
Key Responsibilities:
* Establishing strategies and objectives throughout the quality organisation.
* 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.
Requirements:
* Basic Qualifications: Degree educated with significant relevant experience.
* Solid understanding and knowledge of c GMPs, 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.
Preferred Qualifications:
* B.Sc. in Science, Engineering or equivalent with additional qualifications (Masters /Ph D).
* Considerable experience in transformational change programmes.
* Experience in the development and rolling out of effective training programmes.
About This Role
This role 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.
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.