External Supply QA Senior Manager

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.

Apply now and make a lasting impact with the Amgen team.

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.

. Salary Range

91,082.60 EUR - 123,229.40 EUR