Senior Manager, Clinical Quality

HOW MIGHT YOU DEFY IMAGINATION?

If you feel like youre part of something bigger, its because you are. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of.

Senior Manager, Clinical Quality

Live

What you will do

Lets do this. Lets change the world. In this vital role you will report to the Therapeutic Area Quality Lead - Clinical Quality, Clinical & Research Quality (CRQ). The Senior Manager, Clinical Quality provides proactive end to end quality support for the development and implementation of a risk-based quality assurance strategy for the clinical development program.

Each Senior Manager, Clinical Quality will support end to end Quality Oversight withinone of four Therapeutic Areas (TAs): Oncology; Rare Diseases; General Medicine; Inflammation and Biosimilars.Each Senior Manager, Clinical Quality is responsible for supporting a risk based quality strategy that advances quality by design principles for the full clinical trial lifecycle (protocol development, database lock, and regulatory submissions/ approvals).

You will play a vital role by developing deep knowledge of the clinical trials you support and providing oversight and quality management of critical data and processes for global and local study teams and all clinical trial sites who participate in Amgen sponsored trials.

Responsibilities:

• Serve as a GCP Subject Matter Expert, providing independent and objective quality advice in support of clinical trial activities and in line with current standard methodology.
• Provide quality oversight for Amgen programs for all stages of products in clinical development.
• Plan, conduct and report out on risk-based GCP audits (investigator site audits, affiliate audits, service provider audits, and study level audits).
• Manage/support regulatory inspections and provide guidance and feedback on responses to health authorities, including root cause and CAPA plans.
• Provide quality oversight for the Risk Assessment Categorization Tool (RACT) for each trial to ensure the proper identification, prioritization, and mitigation of risks to critical data and processes and patient safety, welfare, and rights.
• Support Monthly meetings with clinical program level leaders to review quality and compliance related risks, including but not limited to: on-going quality issues/deviations, quality trends, program filing timelines, potential inspections, and risks related to other programs.
• Support response generation for audit findings and self-reported deviations.
• Support the establishment of regional expertise to ensure quality and compliance to local regulations
• Conduct new vendor qualifications/evaluations in a risk-based manner.
• Prepare, analyze, and Identify data quality indicators/trends, identify areas of weakness/gaps, recommend and implement corrective actions and communicate quality metrics and other quality information on periodic basis to key collaborators.
• Support TA-specific oversight of key technologies, including technologies for endpoint data collection and measurement (e.g., biomarker usage and imaging methods).
• Support the development of TA-specific Quality Assurance plans that are risk based and efficient. This includes protocol specific audit plans, and the follow through of audits using various methods (e.g., remote, or on-site).
• Support Clinical Trial Teams for all quality management activities, including management of quality events (e.g., Deviations/CAPAs, Serious Breaches/Privacy Issues, Inspection Readiness activities, and Inspection Management).
• Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-based, data analytics that may demonstrate AI and Natural Language Processing, or other statistically based methods).
• Review clinical trial protocols ensuring simplification, application of lessons learned, and identification of critical data and processes for risk management activities.

  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:

  Basic Qualifications:

  Doctorate degree and 2 years ofQuality Management,Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

  Or

  Masters degree and 6 years ofQuality Management,Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

  Or

  Bachelors degree and 8 years ofQuality Management,Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

  Or

  Associates degree and 10 years ofQuality Management,Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

  Or

  High school diploma / GED and 12 years ofQuality Management,Quality Assurance, or other relevant areas of the pharmaceutical/biotech industry where risk-based quality management and quality by design are a core responsibility.

  In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above

  Preferred Qualifications:

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

Capability to understand and articulate technical concepts and literature in spoken and writtenEnglish.

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

Apply now

for a career that defies imagination

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

careers.amgen.com

Application deadline

External/Internal postings:

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.