Join Amgen’s Mission of Serving Patients
At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.
Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s 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, you’ll 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, you’ll 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
Let’s do this. Let’s 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:
Master’s 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
Bachelor’s 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.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.
In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
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As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.