Amgen's Mission of Serving Patients
We are seeking an accomplished and driven Senior Quality Professional to assume the role of QA Director and Quality Leadership team member for the current ADL1 Manufacturing facility at ADL.
Job Description:
The QA Director - ADL1 Plant Quality Assurance and Plant Technical Quality Assurance (PTQA) is responsible for leading and directing the Quality Assurance functions that support ADL1 and the broader facility in terms of direct oversight of manufacturing activities, technical projects, and aseptic compliance.
This role ensures that licensed pharmaceutical and biopharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations.
Main Responsibilities:
* Establishing strategies and objectives throughout the quality organisation.
* Ensuring facilities, equipment, materials, processes, procedures, and products comply with cGMP practices.
* Reviewing, approving, and tracking cGMP processes, procedures, assays, documents, and records.
* Developing, leadership, and mentoring of the Quality Assurance leaders.
* Collaborating extensively with key internal and external stakeholders.
* Providing advice to management based on quality assurance and compliance matters.
Requirements:
* Degree educated with significant relevant experience.
* Strong leadership skills with significant managerial experience.
* Solid understanding and knowledge of cGMPs, with demonstrated competencies in aseptic manufacturing.
* Awareness and understanding of quality and regulatory industry trends, policies, and guidelines.
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.
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.