Quality Compliance Manager, Safety & Medical Quality

Amgen Inc.

3.6

(9)

Thousand Oaks, CA

Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging
  • #R-198877

    Position summary

    nvestigations and management and remediation of compliance issues relating to processes, programs, and external relationships. This role will support Safety and Medical processes including but not limited to the requirements for Patient Support Programs, Market Research, Digital sites, Social Media and Business Partners. The role will be responsible for supporting processes and activities related to the annual audit plan, the investigation and monitoring of self-reported deviations and the preparation and follow through of audits and inspections.
    Responsibilities:

    • Support the audit plan for PV suppliers/vendors and processes.
    • Support investigations of deviations from GPvP processes including follow through of root cause analysis, design, development or Corrective and Preventive Actions (CAPAs) and Effectiveness Verifications (EVs).
    • Entering and updating records in the digital quality management system (DQMS) based on investigation and deviation meetings and tracking through to closure.
    • Collating and verifying objective evidence for inspection & audit driven CAPAs/EVs.
    • Data entry into the risk assessment tool (using risk assessment methodology)
    • Support Safety and Global Development teams in GxP inspection readiness and inspection management activities.
    • Support Safety and Global Development teams in GxP audits from business partners.
    • Support R&D Quality governance bodies in the clinical development, pharmacovigilance and/or research area.
    • Maintain knowledge of current regulatory and quality practices/issues
    • Collate compliance metrics (e.g. audit/inspection data and other compliance information) to support presentations to key collaborators.
    • Actively seek and implement innovative and proactive quality oversight methodologies (e.g., risk-methods using AI and Natural Language Processing, and other advanced data analytics methods).

    Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a go getter with these qualifications.
    Basic Qualifications:

    Doctorate degree
    Or

    Master's degree and 2 years of R&D, Operations and/or Quality experience
    Or

    Bachelor's degree and 4 years of R&D, Operations and/or Quality experience
    Or

    Associate's degree and 8 years of R&D, Operations and/or Quality experience
    Or

    High school diploma / GED and 10 years of R&D, Operations and/or Quality experience
    Preferred Qualifications:

    • Experience as an auditor, preferably in Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Pharmacovigilance Practice (GPvP)
    • Verbal and Written Communication
    • Teamwork
    • Time Management
    • Interpersonal Skills
    • Analytical Skills
    • Problem Identification and Resolution
    • Diversity Awareness
    • Conflict Management

    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:

    • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
    • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
    • Stock-based long-term incentives
    • Award-winning time-off plans and bi-annual company-wide shutdowns
    • Flexible work models, including remote work arrangements, where possible

    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.

    Salary Range
    108,574.00 USD - 130,252.00 USD

    Why you should apply for a job to Amgen Inc.:

  • 67% say women are treated fairly and equally to men
  • 78% would recommend this company to other women
  • Ratings are based on anonymous reviews by Fairygodboss members.
  • Flexible work models that empower staff members to work where and when they are most productive
  • Award-winning PTO plan and bi-annual company-wide shutdowns
  • With 11 Employee Resource Groups, 60 chapters & 11000 members everyone has opportunity to connect, network & foster a culture of belonging