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Career CategoryQualityJob DescriptionJoin Amgen’s Mission of Serving PatientsAt Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do.Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.DescriptionIn this role you will be serving patients through internal collaboration with Amgen’s global quality teams, manufacturing sites and external engagement with contract manufacturing organizations. You will make key contributions to fulfill Amgen’s missions of serving patients by ensuring supply of high-quality product produced at contract manufacturers to patients.Key Responsibilities
Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain, etc.
Lead the representation, communication and management of quality issues with internal partners and external partners
Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition etc. related to Amgen product.
Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements.
Review completed production batch records as necessary and approve master batch records, and other cGMP documents from CMOs / Contract Laboratories.
Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs.
QA review of all documentation associated with batch release to ensure GMP compliance.
Negotiator, author and Approver of quality agreements
Lead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as applicable or required.
Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers as required. Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
Review / Approve Master Batch Records
Prepare inspection playbooks
Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management
Perform Person in Plant activities as required
APR Data Provider
Provide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
Monitor and communicate site performances in means of quality metrics to Amgen and Contract Manufacturer
Identify prioritization opportunities and determine when escalation is necessary
Develop strong partnership/relationship with CMO / testing Lab
Manage submission related activities at CMOs as it pertains to international launches, global expansion etc.
Authority
Decision to release or Reject batches
Decision to approve or reject deviations, Change Control, CAPA
Decision to approve QAGR
Provide Quality position on GMP related topics and strategy for the site
Decision to approve Master batch Records/Raw Material Specifications
Basic Qualifications:Doctorate degree & 2 years of directly related experience ORMaster’s degree & 4 years of directly related experience ORBachelor’s degree & 6 years of directly related experience ORAssociate’s degree & 10 years of directly related experience ORHigh school diploma / GED & 12 years of directly related experiencePreferred Qualifications:
Preferred Requirements:
10 + years biotech or pharmaceutical industry experience.
Qualified Person status is desirable
Significant Quality experience of Small Molecule or Aseptic Manufacturing
Able to facilitate and influence senior stakeholders and partners
Able to successfully manage workload and timelines
Familiarity with basic project management tools
Ability to negotiate a strategic position after taking feedback from multiple sources
Strong project management, problem-solving, and analytical skills
Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
Ability to operate in a matrixed or team environment with site, functional, and executive leadership
Experience driving decision making by using DAI principles
Experience with the “variation management” process
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation..Salary Range91,082.60 EUR - 123,229.40 EUROriginally posted on Himalayas
Be an integral quality member of Amgen cross-functional contract manufacturing team that includes but is not limited to business operations, analytical science, process development, supply chain, etc.
Lead the representation, communication and management of quality issues with internal partners and external partners
Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition etc. related to Amgen product.
Manage CMOs to contractual obligations relative to Quality Agreement, Amgen specifications, quality, safety and regulatory requirements.
Review completed production batch records as necessary and approve master batch records, and other cGMP documents from CMOs / Contract Laboratories.
Provide quality oversight of the manufacturing, testing, and release of Amgen products at CMOs.
QA review of all documentation associated with batch release to ensure GMP compliance.
Negotiator, author and Approver of quality agreements
Lead the preparation of the site for and Represent Amgen at product-specific Regulatory Inspections and/or during Notified Body audits of CMO Site, as applicable or required.
Contribute to the successful outcome of all regulatory inspections associated with company business, both internally and at contract manufacturers as required. Present on topics during inspection demonstrating appropriate behaviors and knowledge of the subject areas
Review / Approve Master Batch Records
Prepare inspection playbooks
Identify and mitigate Risk at the CMO or testing Laboratories and/or escalate to management
Perform Person in Plant activities as required
APR Data Provider
Provide Amgen Quality support of CMO site activities (e.g., NPI, tech transfer, PPQ, filings, etc.) site in accordance with the Quality Agreement
Monitor and communicate site performances in means of quality metrics to Amgen and Contract Manufacturer
Identify prioritization opportunities and determine when escalation is necessary
Develop strong partnership/relationship with CMO / testing Lab
Manage submission related activities at CMOs as it pertains to international launches, global expansion etc.
Authority
Decision to release or Reject batches
Decision to approve or reject deviations, Change Control, CAPA
Decision to approve QAGR
Provide Quality position on GMP related topics and strategy for the site
Decision to approve Master batch Records/Raw Material Specifications
Basic Qualifications:Doctorate degree & 2 years of directly related experience ORMaster’s degree & 4 years of directly related experience ORBachelor’s degree & 6 years of directly related experience ORAssociate’s degree & 10 years of directly related experience ORHigh school diploma / GED & 12 years of directly related experiencePreferred Qualifications:
Preferred Requirements:
10 + years biotech or pharmaceutical industry experience.
Qualified Person status is desirable
Significant Quality experience of Small Molecule or Aseptic Manufacturing
Able to facilitate and influence senior stakeholders and partners
Able to successfully manage workload and timelines
Familiarity with basic project management tools
Ability to negotiate a strategic position after taking feedback from multiple sources
Strong project management, problem-solving, and analytical skills
Demonstrated ability to lead cross-functional teams, consistently deliver on-time, and high-quality results
Collaborates and communicates well with others, able to balance divergent inputs from various stakeholders and drive issue resolution
Ability to operate in a matrixed or team environment with site, functional, and executive leadership
Experience driving decision making by using DAI principles
Experience with the “variation management” process
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way.In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.Apply now and make a lasting impact with the Amgen team.careers.amgen.comAs an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.Amgen is an Equal Opportunity employer. We make all employment decisions without regard to race, color, religion, sex or any other characteristic protected by applicable law.We provide reasonable accommodations to applicants and employees with disabilities, consistent with legal requirements. Please contact us to request accommodation..Salary Range91,082.60 EUR - 123,229.40 EUROriginally posted on Himalayas