Join Amgen's Mission to Serve Patients
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.
Senior Manager Compliance - Safety DTI
Live
What you will do
Let’s do this. Let’s change the world. In this vital role you will lead our Global Patient Safety (GPS) DTI Compliance Department and handle a small, dedicated team. You will be responsible for encouraging a culture of compliance and regulatory excellence within the DTI organization while ensuring that all processes adhere to industry standards and legal requirements. This role will involve strategic oversight of compliance activities, deviation and CAPA management, regulatory adherence initiatives, and the effective leadership of a small compliance team.
Develop, implement, and promote compliance practices across all teams to ensure consistent adherence to regulatory requirements.
Lead efforts to spread awareness and set a high standard for compliance throughout the Safety DTI organization.
Implement strategies to systematically reduce the number of CAPAs over time through preventive measures and process improvements.
Stay informed of current and upcoming regulations.
Prepare and run timely responses to deviations, ensuring accuracy and adherence to regulatory expectations.
Develop and deploy innovative solutions to improve compliance understanding and implementation within the organization.
Manage the process of SOP (Standard Operating Procedure) changes, including effective communication of updates to all relevant team members.
Regularly update staff on changes to SOPs and regulations, ensuring that everyone is advised and aligned.
Include comprehensive data analysis in the compliance assessments to support decision-making.
Work closely with product owners and business units to ensure that compliance requirements are coordinated into their operations.
Promote cross-departmental awareness of compliance responsibilities, particularly among product teams.
Emphasize the importance of internal compliance and handle CAPAs internally, ensuring that all compliance actions are well-documented and aligned with company policies.
Lead the training of teams on evolving SOPs and compliance best practices, ensuring continuous professional development and adherence to standards.
Mentor and guide compliance staff to develop a proactive and knowledgeable compliance team.
Implement and coordinate continuous improvement initiatives aimed at reducing the number of CAPAs and improving the overall integrity of processes.
Regularly review and update compliance procedures to reflect best practices and regulatory changes.
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. We are seeking a detail-oriented and experienced Senior Manager to lead our Safety Digital Technology Innovation (DTI) Compliance Department.
Basic Qualifications:
Doctorate degree and 2 years of Information Systems experience OR
Master’s degree and 8 to 10 years of Information Systems experience OR
Bachelor’s degree and 10 to 14 years of Information Systems experience OR
Diploma and 14 to 18 years of Information Systems experience
Preferred Qualifications:
10+ years of IT Industry work experience in Analysis, Design, Development, Testing and Maintenance of software applications in Health & Life Sciences
5+ years' of experience supporting Global Patient Safety or Compliance related activities
7+ years’ of experience working on and leading major programs/projects that involve multiple partners and external vendors and leading end-to-end from initiation to project closure
Strong communications skills in writing, speaking, addressing various audiences in a clear and concise manner
Experience in DevOps, and Scaled Agile Framework (SAFe), especially in regulated setting including ability to lead the transformation of teams from a service based to a product-based model
Experience with Quality Control and Quality Assurance processes and systems
Demonstrable experience in group facilitation – ability to guide teams to make decisions and achieve results within agreed parameters & timescales
Prior experience as a people manager, a program/ project team lead or mentor of team
In-depth experience in all aspects of SDLC from requirements, design, testing, data analysis and Change Control process combined with experience developing project charters, statement of work and project financials
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
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
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
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Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with 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 an accommodation.