Senior QA Manager

Location: Holly Springs
Posted on: June 23, 2025

Job Description:

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. 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. Senior QA Manager What you will do Lets do this! Lets change the world! In this vital role, you will lead a team of Quality professionals supporting the Disposition and Incoming Quality operations at our North Carolina site. You will provide technical quality leadership and oversight of Disposition and Incoming Quality, partnering closely with cross-functional teams to build, enhance and sustain compliant commercial operations. Specific responsibilities include but are not limited to: Lead, manage, and motivate a high-performing team of Quality professionals across key areas, including QA support for Disposition and Incoming QA, and their applicable quality systems (e.g., Document Management, Change Control, and Deviations). Ensure team members are properly trained and qualified to perform their duties in accordance with cGMP and regulatory requirements. Oversee workload distribution, resource planning, and departmental budgeting, including forecasting and monitoring. Own the development, implementation, and continuous improvement of the site's inspection readiness program and overall Quality Management System (QMS), ensuring compliance with Amgen standards, cGMP, and applicable regulations. Ensure timely review, approval, and tracking of key cGMP processes, documents, and records, including deviations, CAPAs, Change Controls, validation protocols, and assays. Lead cross-functional investigations of deviations, ensure appropriate documentation, and assess changes for potential product quality impact. Stay current with regulatory developments and quality trends to maintain a compliant and forward-thinking quality program. Represent the Quality unit during internal and external audits and regulatory inspections. Alert senior management to significant quality, compliance, supply, or safety risks, using sound judgment and cross-functional coordination when needed. Manage hiring, succession planning, and performance development to ensure organizational capability and talent pipeline. What we expect of you We are all different, yet we all use our unique contributions to serve patients! The Manager Quality Control professional we seek is a strong leader with these qualifications. Basic Qualifications: High school diploma / GED and 12 years of Quality and Manufacturing support industry experience OR Associates degree and 10 years of Quality and Manufacturing support industry experience OR Bachelors degree and 8 years of Quality and Manufacturing support industry experience OR Masters degree and 6 years of Quality and Manufacturing support industry experience OR Doctorate degree and 2 years of Quality and Manufacturing support industry experience Preferred Qualifications: Educational background in Life Science and/or Engineering Proven experience in Quality oversight of Incoming, Warehouse, and Disposition, with a strong focus on quality systems. In-depth knowledge of cGMPs, regulatory requirements, and pharmaceutical processing, with demonstrated ability to apply compliance principles in practice. Hands-on experience with Disposition, Incoming, and Quality Systemsparticularly investigations, corrective actions, and audit readiness. Experience managing and interacting with regulatory and internal auditors. Demonstrated leadership of Quality teams, with strong team development, collaboration, and mentoring skills. Effective risk management, negotiation, and cross-functional collaboration abilities. Excellent written and verbal communication, facilitation, and presentation skills in both English and Spanish. 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. 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: 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, including remote and hybrid work arrangements, where possible 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. 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.

Keywords: , Fayetteville , Senior QA Manager, Science, Research & Development , Holly Springs, North Carolina