Director - Quality Assurance

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.

Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Director - Quality Assurance

What you will do

Lets do this. Lets change the world. In this vital role you will be overseeing the functions within Quality Assurance, Product Quality, Quality Operating Systems and IT Services functions within AIN. This role is pivotal in ensuring that all products and services meet or exceed both internal quality standards and external regulatory requirements. This position will lead a team of quality professionals and work collaboratively with other departments to promote a culture of continuous improvement and operational excellence.

• Develop and Implement Quality Strategies: Design and implement comprehensive quality management strategies to ensure compliance with industry standards and regulatory requirements.
• Leadership and Team Development: Lead, mentor, and develop the quality assurance team to foster a high-performance culture.
• Quality System Management: Oversee the development, implementation, and maintenance of the company's quality management system (QMS).
• Develop, implement, and maintain validation protocols and reports for Equipment (URS, IQ, OQ, PQ) and Computer systems (Part 11, EU GAMP 5).
• Product Quality Management: Collect and analyze data for meaningful insights and signals that indicate an adverse trend as per established statistical tools. The data may include programs such as, stability, specifications, comparability, analytical methods, annual product reviews (APR) and may be used for regulatory submissions and formal PQ risk assessments.
• Regulatory Compliance: Ensure all products and processes and systems comply with relevant regulatory standards (e.g., ISO, FDA, ICH, EU etc.).
• Quality Audits: Plan and conduct internal and external quality audits to identify areas for improvement and ensure compliance with standards.
• Supplier Quality Management: Develop and maintain robust supplier quality management processes to ensure materials and services meet quality standards.
• Customer Satisfaction: Collaborate with customer service and other relevant departments to address quality-related customer concerns and complaints.
• Reporting: Provide regular reports and updates to senior management on quality metrics/KPI, performance, and issues.
• Continuous Improvement: Promote and lead continuous improvement initiatives across the organization to enhance product quality and operational efficiency.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The quality assurance professional we seek would have these qualifications.

Basic Qualifications:

• Masters degree in Quality, Engineering or, related field and 14 to 16 years of experience in quality management, with at least 10 years in a leadership role OR
• Bachelors degree in Quality, Engineering or, related field and 16 to 18 years of experience in quality management, with at least 10 years in a leadership role
• Strong knowledge of Biologics and Drug manufacturing and testing process in GMP environment (Cell culture, Fermentation, Purification, Aseptic Filling and Visual inspection, Potency and Purity assays using ELISA, Cell Based, SE-HPLC, UP-HPLC IcIEF etc.)
• Strong knowledge of quality management systems and software and relevant regulatory requirements (change control, failure investigations, CAPA)
• Good understanding of regulatory submissions (BLA, NDA, MAA etc.) as it pertains to CMC modules.
• Good understanding of product quality risk assessments, mitigation and risk ratings.
• Excellent leadership and team development skills.
• Strong analytical and problem-solving abilities.
• Effective communication and interpersonal skills.
• Proficiency in quality management software and tools.

Professional Certification:

• Relevant quality certifications (e.g., Six Sigma, ISO Lead Auditor, CQE or CQM/OE) are highly desirable.