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    Quality Compliance - Senior Manager

    Amgen
    2+ years
    Not Disclosed
    Hyderabad
    10 Nov. 26, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Quality Compliance - Senior Manager
    Amgen Singapore Manufacturing

    Join Amgen’s Mission of Serving Patients

    At Amgen, we are driven by our shared mission to serve patients living with serious illnesses. Since 1980, we’ve pioneered the world of biotech in our fight against the world’s toughest diseases. With a focus on Oncology, Inflammation, General Medicine, and Rare Disease, we reach millions of patients each year. As part of the Amgen team, you’ll help make a lasting impact on the lives of patients by researching, manufacturing, and delivering innovative medicines to help people live longer, fuller, and happier lives.

    Our collaborative, innovative, and science-based culture offers a place where you can thrive, challenge yourself, and grow your career. Join us in transforming patient lives while advancing your professional journey.

    What You Will Do

    In this critical role, you will be responsible for implementing Global Quality Compliance Audits and managing key tasks and projects that contribute to achieving corporate and departmental goals. This includes the following responsibilities:

    • Quality Compliance Audits: Coordinate, lead, or participate in Corporate Quality Compliance Audits of Amgen sites, affiliates, contract facilities, and critical service providers to assess compliance with all applicable regulations and identify compliance risks.
    • Compliance Assessments: Assess the state of compliance with appropriate regulations and lead or participate in the development of action plans to address deficiencies.
    • Risk Management: Implement and oversee risk assessments, ensuring proper documentation and sustainability of training programs to support the audit process.
    • Compliance Leadership: Lead compliance efforts across multiple sites, providing technical support and resolving compliance issues as needed. Act as a subject matter expert on global regulatory requirements and inspection commitments.
    • Regulatory Support: Provide support for domestic and international regulatory authority inspections when necessary.
    • Interdepartmental Collaboration: Work with functional teams to align Amgen’s strategies with existing regulations and regulatory expectations. Ensure senior management is alerted to significant compliance risks.
    • Continual Improvement: Support ongoing initiatives and projects aimed at continuous improvement of compliance processes.

    What We Expect of You

    We value the unique contributions of every individual. The ideal candidate will bring the following qualifications:

    Basic Qualifications:

    • Doctorate degree and 2 years of compliance experience, OR
    • Master’s degree and 8 to 10 years of compliance experience, OR
    • Bachelor’s degree and 10 to 14 years of compliance experience, OR
    • Diploma and 14 to 18 years of compliance experience

    Preferred Qualifications:

    • Lead Auditor Certification
    • Experience in auditing Drug Substance (DS), Drug Product (DP), Finished Drug Product (FDP), Medical Device, Combination Product, and/or Active Pharmaceutical Ingredients (API)
    • Strong written and verbal communication skills
    • Domestic and international travel required, up to 50%

    What You Can Expect of Us

    At Amgen, we are committed to supporting your professional and personal growth. You can expect:

    • Learning and Career Development: Ample opportunities for learning and career advancement within a global organization.
    • Inclusive Culture: A diverse and inclusive environment where teammates are empowered to bring ideas to the table and make an impact.
    • Comprehensive Benefits: A competitive Total Rewards Plan, including health, financial, and career benefits.

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    Brazil | Sao paulo |

    South America :

    Argentina | Peru |

    Catalonia :

    Barcelona |

    Madrid :

    Madrid |

    Sweden :

    Sweden |

    Taipei :

    Taipei |

    Williamson :

    Brentwood |

    Republic of Thailand :

    Bangkok |

    Kyiv Oblast :

    Kyiv |

    Dubai :

    Dubai |

    Hà Nội :

    Hanoi | Hà Nội |

    Ho Chi Minh :

    Ho Chi Minh City |