Quality Compliance Senior Manager, Research Quality

Career Category

Job Description

Join our team at Amgen Capability Center Portugal the #1 company in Best Workplaces (201500 employees category) in 2024 by the Great Place to Work Institute. With over 400 talented individuals from more than 40 nationalities our Lisbon center thrives at the intersection of innovation excellence and inspiration. This is your opportunity to explore the future of healthcare through technology and digital innovation supporting our mission To Serve Patients.

QUALITY COMPLIANCE SENIOR MANAGER RESEARCH QUALITY

LIVE

What you will do

Lets do this. Lets change the this vital role you will report to the Director Quality Compliance. The Quality Compliance Sr. Manager provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the nonclinical development program.

The Research Quality strategy is focused on nonregulated and regulated research at Amgen including Good Laboratory Practice (GLP) spanning from discovery through first in human use. This strategy will ensure that all research methods at Amgen meet internal and external quality standards and encompass good laboratory procedures equipment and systems for research activities performed internally and externally through third-party vendors/suppliers. Maintaining the Integrity of our research data will be a key focus for this role including data generated in collaboration with third-parties.

You will play a vital role in performing GLP phase audits for studies conducted on-site at Amgen as well as auditing the data and final reports associated with these studies. Your skills and knowledge will provide key oversight and quality management of critical data and processes for our global Research organization and those vendors who participate in Amgen sponsored trials.

Responsibilities:

• Serve as a GLP Subject Matter Expert providing independent and objective quality advice in support of Research-based activities and in line with current best practice.

• Provide quality oversight for Amgen programs for all stages of products within Research.

• Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities including root cause and CAPA plans.

• Plan conduct and report out on risk-based R&D audits. Review negotiate and approve responses to R&D audit findings and provide oversight for compliance activities through finding closure.

• Manage and track deliverables monitor trends and provide data and recommendations regarding the state of quality for processes technology laboratory and external vendor performance.

• Support meetings with stakeholders and vendors to review quality and compliance-related risks.

• Conduct new vendor qualifications/evaluations in a risk-based manner.

• Champion the development and implementation of Quality Plans Global Quality processes and controlled documents pertaining to R&D Quality.

• Support the establishment of regional expertise to ensure quality and compliance to local regulations.

• Support research-specific data integrity including technologies for data collection and measurement.

• Support Research for all quality management activities including Deviations/CAPAs Inspection Readiness activities and Inspection Management and compliance related questions and escalations.

• Actively seek and implement innovative and proactive quality oversight methodologies (e.g. risk-methods leveraging AI and Natural Language Processing and other advanced data analytics methods).

• Maintain knowledge of current regulatory and subject matter areas of expertise (e.g. GLP GCP).

WIN

What we expect of you

We are all different yet we all use our unique contributions to serve patients. The individual we seek has technological literacy and leadership skills and has these qualifications:

• Degree Educated

• 7 years or more experience in Quality Management Quality Assurance or other relevant areas of the pharmaceutical/biotech industry where risk-based quality and quality by design are a core responsibility.

• Leadership or mentoring experience.

• Experience with compliance to Good Laboratory Practices including partnership with third-party vendors suppliers and partners.

• Oversight of Quality Management Systems and experience managing quality in electronic QMS such as Veeva or Trackwise.

• Thorough understanding of R&D activities and Global Regulations.

• Knowledge of the Regulatory Submission and Inspection Management procedures.

• Quality Oversight of Nonclinical Trials including auditing GLP phases data and final reports.

• Excellent verbal and written communication skills including strong business writing abilities and active listening.

• Ability to transform business and stakeholder feedback into clear efficient processes using a straightforward language and format.

• Strong analytical critical-thinking and decision-making abilities.

• Capability to understand and articulate technical concepts and literature in spoken and written English.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn develop and move up and across our global organization.

• Diverse and inclusive community of belonging where colleagues are empowered to bring ideas to the table take risks and act.

• Generous Amgen Total Rewards Plan comprising healthcare finance wealth and career benefits.

• Flexible work arrangements.

Objects in your future are closer than they appear. Join us.

EQUAL OPPORTUNITY STATEMENT

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 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.