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Job Description
Manager PQA Employer Amgen Location New Albany, Ohio Start date Jun 3, 2026 View more categories View less categories Discipline Engineering , Manufacturing & Production , Quality , Quality Assurance Required Education High School or equivalent Position Type Full time Hotbed Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do. Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases. With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Disease 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Manager PQA What you will do Lets do this. Lets 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 functionits a mindset. Were 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, its 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: Deviations CAPAs Change Controls Validation documentation Procedures and batch records 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 What we expect of you We are all different, yet we all use our unique contributions to serve patients. The quality professional we seek will possess these qualifications.
Basic Qualifications:
Doctorate degree OR Masters degree and 3 years of quality experience OR Bachelors degree and 5 years of quality experience OR Associates 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:
Bachelors 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 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, well support your journey every step of the way. 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: A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan Stock-based long-term incentives Award-winning time-off plans Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies. Apply now and make a lasting impact with the Amgen team. careers.amgen.com 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 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. Company We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world's leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide. We live the mission. We win together. We thrive on continual challenge. Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission. At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we're transforming the promise of science and biotechnology into therapies that have the power to restore health. Connect with us to explore how you can Win, Live, and Thrive at Amgen.
Company info Website http:
//careers.amgen.com/ Phone 805-447-1000 Location Corporate Headquarters One Amgen Center Drive Thousand Oaks California 91320-1799 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert
