Mgr Quality Assurance - AML 7 Night Shift

HOW MIGHT YOU DEFY IMAGINATION?

Youve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge youve worked hard to acquire and the passion you already have. At Amgen, our shared missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.

Manager Quality Assurance - AML 7 Drug Substance for Night Shift

LiveWhat you will do

Lets do this. Lets change the world! In this vital role you will be responsible for leading and supervising the Quality Assurance (QA) team in our AML7 Drug Substance Operations reporting to a night shift as a non-standard operation. The QA Manager will lead the Plant Quality Assurance staff overseeing the manufacturing activities occurring in manufacturing areas such as component preparation, fermentation, purification, pegylation and bulk final filtration, among others. Also provides Quality support to the manufacturing floor, assists in the resolution of issues, and manages GMP records. The area is very dynamic with a high number of production lots, investigations and projects in a fast-paced environment. Specific responsibilities include but are not limited to:

• Direct management of on-the-floor QA activities including but not limited to oversight of the Drug Substance processes, batch record review, deviation investigation, change controls and SOP revisions, among others.
• Strong collaboration and partnership cross functionally (i.e. Manufacturing, Process Development, Regulatory, etc.) to ensure the Quality Management System processes are executed in accordance with established procedures. Ensuring production in full cGMP compliance.
• Strategic advisor to senior management of quality, compliance, supply, and safety risks.
• Mentoring, coaching, and developing staff to build highly skilled, diverse, and inclusive teams.
• Fostering a positive and respectful work environment that encourages staff retention and motivates individuals to work toward common goals and priorities.
• Growing core skills and capabilities among staff, particularly in learning agility, problem solving, strategic and creative thinking, flexibility, resilience, effective communication, prioritization, delivery of results, and continuous improvement.
• Making accurate evaluations of your team's skills and competencies and providing timely and respectful feedback, including direct delivery of difficult messages.
• Resolve critical gaps in the organizations internal capabilities and skillsets, including strategic external recruiting as needed. Identifying also diverse, qualified successors for key positions.
• Ensure maintenance and re-validation of systems with expertise in EBR, SAP, Trackwise, Maximo systems.
• Review and approve product MPs, process validation protocols and reports for manufacturing processes.

WinWhat we expect of you

We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Assurance professional we seek is a strong leader with these qualifications.

Doctorate degree

OR

Masters degree and 3 years of Quality or Manufacturing experience in GMP regulated environment

OR

Bachelors degree and 5 years of Quality or Manufacturing experience in GMP regulated environment

And

Previous managerial experience directly handling people and/or experience leading teams, projects, programs or managing the allocation of resources.

Additional preferred qualifications are:

• Educational background in Life Science or Engineering
• Experience leading cross functional teams with the influencing and negotiating skills
• Validated expertise in Quality Systems such as Deviations, CAPA and Change Control
• Experience in computer systems validation or computer systems quality assurance
• Experience with Validation of GxP applications, Validation Master Plan, Installation Qualification (IQ), Risk Assessment/GxP assessment, Operational Qualification (OQ), and Performance Qualification (PQ) Protocols, Test Scripts, and Completion/Summary Reports approvals as per the compliance requirements
• Strong organizational, project management and change management skills
• Ability to motivate staff and manage and distribute workloads
• Demonstrate ability to interact with regulatory agencies
• Solid word processing, presentation, database and spreadsheet application skills
• Strong communication skills (both written and oral), and comprehend in English and Spanish
• Proven skill in working independently and to effectively interact with all levels throughout the organization
• Advanced data trending & evaluation and ability to evaluate compliance issues

ThriveSome of the vast rewards of working here

As we work to develop treatments that take care of others, so we work to care for our teammates professional and personal growth and well-being.

• Full support and career-development resources to expand your skills, enhance your expertise, and maximize your potential along your career journey
• A diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plancomprising health, finance and wealth, work/life balance, and career benefitswith compensation and benefits rated above 4 stars (out of 5) on Glassdoor

Apply now for a career that defies imagination

Objects in your future are closer than they appear.

Join us: careers.amgen.com

Equal Opportunity Statement

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 a 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 an accommodation.

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Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Amgen requires all staff in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of employment. In accordance with applicable law, Amgen will provide reasonable accommodations to staff members who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to Amgen, its operations, or its staff.