External Supply QA Senior Manager

Amgen; United States; Teletrabalho; USD 101 000 - 137 000; Tempo integral

Resumo da oferta

Amgen is seeking a high-level Quality professional to join the team and ensure supply of high-quality product from CMOs. You will collaborate with global quality groups, manufacturing sites and contract manufacturers to support patient safety and regulatory readiness.

The role involves leading quality reviews, approvals, and inspections readiness, with extensive cross-functional interaction and strong leadership capabilities.

Qualificações

• Doctorate degree with 2 years of related experience.
• Master’s degree with 4 years of related experience.
• Bachelor’s degree with 6 years of related experience.
• Associate’s degree with 10 years of related experience.
• High school diploma / GED with 12 years of related experience.
• 10+ years biotech or pharmaceutical industry experience.
• Qualified Person status is desirable.
• Significant Quality experience in Small Molecule or Aseptic Manufacturing.
• Ability to facilitate and influence senior stakeholders and partners.
• Strong project management, problem-solving, and analytical skills.

Responsabilidades

• Be an integral quality member of Amgen cross-functional contract manufacturing team.
• Lead the representation, communication and management of quality issues with internal and external partners.
• Serve as the main Quality point of contact and approver for deviations, change controls, CAPAs, and batch disposition 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 and approve master batch records and other cGMP documents from CMOs.

Conhecimentos

Biotech/pharma exp

Qualified Person (QP)

Small molecule QA

Project management

Stakeholder management

Quality assurance

GMP knowledge

Cross-functional leadership

Regulatory inspections

Risk management

Formação académica

Doctorate + 2 yrs exp

Master’s + 4 yrs exp

Bachelor’s + 6 yrs exp

Associate + 10 yrs exp

HS diploma/GED + 12 yrs exp

Descrição da oferta de emprego

Career Category

Quality

Job Description

Join Amgen’s Mission of Serving Patients

At 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.

Description

In 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 OR

Master’s degree & 4 years of directly related experience OR

Bachelor’s degree & 6 years of directly related experience OR

Associate’s degree & 10 years of directly related experience OR

High school diploma / GED & 12 years of directly related experience

Preferred 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 us

As 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.

careers.amgen.com

As 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.

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Salary Range

91,082.60EUR-123,229.40EUR