At Amgen, if you feel like youâre part of something bigger, itâs because you are. Our shared missionâto serve patients living with serious illnessesâdrives all that we do.
Since 1980, weâve helped pioneer the world of biotech in our fight against the worldâs toughest diseases. With our focus on four therapeutic areas âOncology, Inflammation, General Medicine, and Rare Diseaseâ we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, youâll 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, youâll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Letâs do this. Letâs change the world. At Amgen, our mission to serve patients drives everything we do. At our Ohio site, we are building a culture where quality is not just a functionâitâs a mindset. Weâre seeking a Manager, Quality Assurance who is passionate about leadership, thrives in a dynamic environment, and is ready to make a tangible impact on product quality and patient safety.
This is more than a role, itâs an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.
Lead Quality. Inspire Excellence. Impact Patients.
As a QA Manager, you will lead and elevate quality performance while providing strategic and operational oversight across manufacturing and quality systems. Key responsibilities include:
¡Lead, coach, and develop Quality staff across assigned areas and shifts
¡Provide QA oversight of manufacturing packaging activities to ensure compliance with cGMP, GDP, and global regulatory requirements
¡Ensure that facilities, equipment, processes, materials, and products meet all applicable quality and compliance standards
¡Review, approve, and oversee key quality systems including:
¡Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
¡Ensure production records and test results are accurate, complete, and inspection-ready
¡Champion and lead continuous improvement initiatives to strengthen quality systems and operational performance
¡Partner cross-functionally with Manufacturing, QC, Engineering, Supply Chain, and other stakeholders
¡Assess and manage quality risks, escalating critical issues to senior leadership as needed
¡Represent QA during internal and external audits and regulatory inspections
¡Support audit readiness and participate in inspection management activities
¡Ensure document control excellence, including ownership and timely periodic review of controlled documents
¡Foster a culture of quality, accountability, and compliance across all teams
We are all different, yet we all use our unique contributions to serve patients. The [vital attribute] professional we seek is a [type of person] with these qualifications.
Basic Qualifications:
Doctorate degree
OR
Masterâs degree and 3 years of quality experience
OR
Bachelorâs degree and 5 years of quality experience
OR
Associateâs degree and 10 years quality experience
OR
High school diploma / GED and 12 years of quality experience
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, prograns, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above
Preferred Qualifications:
Bachelorâs degree in Life Sciences, Engineering, or a related field (advanced degree a plus)
3+ years of experience in Quality Assurance within a GMP-regulated environment (biotech/pharma preferred)
Prior leadership or people management experience strongly preferred
Deep knowledge of cGMP, GDP, and regulatory expectations
Proven experience with quality systems (deviations, CAPA, change control, validation)
Strong ability to lead in a shift-based operation, with flexibility for evenings, nights, weekends, or holidays
Excellent communication, decision-making, and problem-solving skills
A proactive, collaborative leader who can influence and inspire across functions
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, weâll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Sponsorship for this role is not guaranteed.
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 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 and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided 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 accommodation.
.Salary Range
118,235.00USD -159,965.00Â USDamgen