Senior Manager Quality Assurance: Incoming Quality and Warehouse

Senior Manager QA

What you will do

At our Ohio site, we are building a culture where quality is not just a function—it’s a mindset. We’re seeking a Senior 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, it’s an opportunity to lead from the front, shape quality culture, and ensure we deliver safe, effective therapies to patients worldwide.

• 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.

• Doctorate degree and 2 years of Quality/Manufacturing/Engineering experience.
• OR Master’s degree and 6 years of Quality/Manufacturing/Engineering experience.
• OR Bachelor’s degree and 8 years of Quality/Manufacturing/Engineering experience.
• OR Associate’s degree and 10 years of Quality/Manufacturing/Engineering experience.
  
  OR High school diploma / GED and 12 years of quality/Manufacturing/Engineering experience.
• In addition to meeting at least one of the above requirements, you must have a minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.

• 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.

We offer a comprehensive employee benefits package including:

• Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
• 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.

What you can expect of us While we work to develop treatments that take care of…