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.
Manager Quality Assurance
Let’s do this. Let’s change the world. In this vital role you will responsible for overseeing and enhancing our DMS to ensure compliance with industry standards and continuous improvement of our processes. This role requires a strategic problem solver with a strong technical background and exceptional organizational and communication skills.
Oversee a group of 5 to 10 staff ensuring their activities and priorities are managed in a compliant, structured manner.
Ensures team are appropriately qualified and trained to carry out their DMS activities in a compliant manner per company procedures.
Oversee and manage the budget associated with this staff including performing goal setting, performance reviews and compensation planning.
Continuously improve documentation processes and practices to enhance efficiency and quality.
Develop, implement, and maintain the DMS in accordance with industry standards and regulatory requirements.
Conduct internal audits and coordinate external audits to ensure compliance with DMS standards.
Analyze data and metrics to identify trends and areas for improvement in the DMS.
Collaborate with various departments to resolve discrepancies and ensure consistent documentation practices.
Provide training and support to staff on DMS processes and standard methodologies.
Manage DMS-related projects, including setting goals, tracking progress, and ensuring timely completion.
Stay current with industry trends and updates to DMS standards.
Provide technical and organizational leadership toward resolving site and multi-site compliance issues.
Provide support for domestic and foreign regulatory agency site inspections, as needed.
Interact with other functional leads to ensure that operational standards, strategies, and direction meet organizational goals/objectives and are aligned with existing regulations and regulatory expectation.
Monitor and bring up to senior management and management review established metrics representative of the health of the Document Management process.
Support Continual Improvement initiatives, programs, and projects including owning and driving CAPAs, owning and revising documents.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree OR
Master’s degree and 4 to 6 years of quality management systems or a related field experience OR
Bachelor’s degree and 6 to 8 years of quality management systems or a related field experience OR
Diploma and 10 to 12 years of quality management systems or a related field experience
Certifications in quality management (e.g., ISO 9001, Six Sigma) are highly desirable.
Proven experience in conducting audits and managing DMS-related projects.
Preferred Qualifications:
Technical Proficiency: Strong knowledge of technical writing tools and software, including MS Word, MS Excel, SharePoint, and Veeva platform.
Attention to Detail: Ability to meticulously review and edit documentation to ensure accuracy and consistency.
Communication: Excellent verbal and written communication skills, with the ability to effectively collaborate with various departments and resolve discrepancies.
Organizational Skills: Strong ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
Adaptability: Ability to quickly grasp new concepts and react to changes in a rapidly evolving environment.
Teamwork: Ability to work well with others and contribute to a positive team environment.
Problem-Solving: Strong analytical skills to identify and resolve issues related to documentation.
Customer Focus: Commitment to understanding and meeting the needs of internal and external key collaborators.
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.
Objects in your future are closer than they appear. Join us.
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.