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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. 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, 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.
Job Responsibility
Lead, coach and develop the QA team, responsible for quality oversight of Incoming Quality, Warehouse Operations, Distribution and Facility and Engineering. Team scope includes disposition of product, materials and components, including on-the-floor support, record review, quality oversight of deviation investigations and changes, document approval
Ensure AOH product is manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Amgen standards, and applicable regulations
Drive investigations and resolution of deviations, ensuring timely, thorough, and compliant outcomes
Lead and participate in Quality Risk Assessments
Provide Quality input to support project or operational design decisions
Build organization according to hiring strategy that supports our growth. Partner with HR to recruit, coach, develop, motivate, and retain staff. Ensure ongoing organizational structure capable of adapting to evolving business needs
Provide oversight to ensure that Amgen Quality Management System is implemented and maintained in accordance with corporate standards
Track performance and drive continuous improvement in the performance and delivery of quality outputs in alignment with Quality strategies
Develop strategies in support of regulatory inspections and site audits
Serve as quality representative to regulatory authorities, Amgen Corporate auditors, and 3rd Parties
Develop area budget, manage expenditure and identify productivity improvement opportunities
Represent AOH Quality in cross-function and cross-site forums
Alert management of significant quality, compliance, supply, and safety risks
Communicate across all levels of the organization. Facilitate development of solutions to critical business issues
Requirements
Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience
Master's degree and 6 years of Quality/Manufacturing/Engineering experience
Bachelor's degree and 8 years of Quality/Manufacturing/Engineering experience
Associate's degree and 10 years of Quality/Manufacturing/Engineering experience
High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience
minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources
Nice to have
Master or Bachelor’s Degree in a Life Science field
5 + years’ pharmaceutical industry experience
Previous experience in Quality oversight
Strong knowledge of cGMPs and experience interacting with Regulators
Proven experience with quality systems (deviations, CAPA, change control, validation)
Able to drive process improvement within area of responsibility
Able to successfully manage workload to timelines, decision-making, and problem-solving skills
Leadership and communication skills. A proactive, collaborative leader who can influence and inspire across functions
What we offer
health and welfare plans for staff and eligible dependents
financial plans with opportunities to save towards retirement or other goals
work/life balance
career development opportunities
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