[1/25/2025 A] QA Director

QA Director – ADL1 Plant Quality Assurance and Plant Technical Quality Assurance (PTQA)

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 that can provide you the opportunity to learn and develop self, whilst developing and advancing a team of quality professionals?

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 – ADL1 Plant Quality Assurance and Plant Technical Quality Assurance (PTQA)

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 for the current ADL1 Manufacturing facility at ADL. The ADL1 manufacturing facility is a well-established aseptic manufacturing facility comprising both vial and syringe drug product formulation, filling and inspection activities employing next generation methodologies.

The Director of Quality Assurance for ADL1 Plant Quality Assurance (PQA) including QA Aseptic compliance, 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.

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 of the manufacturing facility within the ADL1 manufacturing plant and will also be responsible for the quality oversight and direction for key New Product Introductions/Technology Transfers, Life-Cycle management validation efforts and technical projects.

You will establish, lead, direct and inspire the ADL1 and PTQA Quality functions and will be a key member of the Quality Leadership and Operations teams at ADL. This role is pivotal in ensuring that quality standards are met and maintained throughout all phases of manufacturing and qualification/validation efforts at the ADL facility.

This position requires demonstration of strong 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 and stakeholder teams to own and manage Quality.
- Ensure facilities, equipment, materials, processes, procedures, and products comply with cGMP practices, whilst advancing aseptic compliance programs at ADL.
- Review, approve, and track cGMP processes, procedures, assays, documents, and records, including Deviations, CAPAs, and validation/qualifications related to ADL1 plant operations.
- Development, leadership and mentoring of the Quality Assurance leaders to 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, operation schedule, processes, and budgets.
- Key responsibility for inspection preparedness and for undertaking and interacting with regulatory agencies, partners and corporate functions during site inspections and post-inspection response process.
- 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 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.

#J-18808-Ljbffr