Senior Manager Quality Assurance  – Major Deviations Lifecycle Team

Amgen • Juncos, PR

25d

About The Position

Join Amgen’s Mission of Serving Patients. 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. Sr Mgr Quality Assurance – Major Deviations Lifecycle Team. What you will do. Let’s do this. Let’s change the world. In this vital role you will be responsible for leading the Major Deviations Team and ensuring the timely, compliant, and effective management of significant quality events across manufacturing, packaging, laboratory, and support operations. This role provides strategic oversight of deviation investigations, root cause analyses, risk assessments, corrective and preventive actions (CAPAs), and regulatory compliance activities to ensure product quality and patient safety. The Senior Manager partners cross-functionally with Quality Assurance, Quality Control, Manufacturing, Engineering, Supply Chain, Regulatory Affairs and Compliance, Process Development, Environmental Health and Safety, and Validation to drive robust investigations, continuous improvement initiatives, and inspection readiness. The role translates site, functional, and business priorities into operational objectives for the Major Deviations program and ensures alignment with broader Quality and organizational strategies.

Requirements

• Doctorate degree and 2 years of quality support experience OR Master’s degree and 6 years of quality support experience OR Bachelor’s degree and 8 years of quality support experience OR Associate’s degree and 10 years of quality support experience OR High school diploma / GED and 12 years of quality support experience
• A minimum of 2 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Nice To Haves

• Educational background in Life Science and/or Engineering.
• Strong understanding of cGMP regulations and FDA, EMA, and global regulatory expectations.
• 8+ years of experience in Quality Assurance, Quality Systems, Manufacturing, or Compliance within the pharmaceutical, biotechnology, or another regulated industry.
• Strong experience managing major deviations, investigations, CAPAs, and regulatory interactions is preferred.
• Knowledge of electronic quality systems and data-trending tools with expertise in deviation investigation methodologies and quality risk management principles.
• Experience leading and supporting inspection readiness and regulatory audits.
• 3+ years of leadership or people management experience with the ability to lead cross-functional teams within a fast-paced, highly regulated environment
• Strong analytical, problem-solving, and decision-making skills.
• Solid communication and presentation skills, with the ability to influence stakeholders at multiple organizational levels.
• Strong organizational skills, with the ability to manage multiple priorities simultaneously.
• Robust leadership capabilities, including strategic thinking, operational execution, team development and coaching, cross-functional collaboration, stakeholder management, a strong quality and compliance mindset, continuous improvement orientation, and sound decision-making under pressure.

Responsibilities

• Lead and manage the Major Deviations Team, including performance management, coaching, employee development, and resource planning.
• Provide oversight and direction for complex and high-impact deviation investigations to ensure scientific, technical, and regulatory rigor.
• Ensure deviations are initiated, investigated, approved, and closed within established quality timelines and procedural requirements.
• Drive effective root cause analyses using structured investigation methodologies and risk-based decision-making.
• Maintain accountability for: Timely initiation and designation of deviations, Robust root cause investigations, Accurate documentation within the digital quality management system (DQMS), Effective CAPA and effectiveness verification (EV) execution.
• Escalate critical quality issues appropriately to site leadership and Quality Management.
• Collaborate with cross-functional teams to identify systemic issues and implement sustainable corrective actions.
• Monitor deviation trends and quality metrics to identify recurring issues and continuous improvement opportunities.
• Support internal audits, regulatory inspections, and customer audits related to deviation management and quality systems.
• Ensure all major deviations are inspection-ready and meet applicable regulatory expectations, including FDA and EMA requirements.
• Ensure compliance with current Good Manufacturing Practices (cGMP), company procedures, data integrity expectations, and global quality standards.
• Lead major deviation improvement programs and strategic initiatives involving multiple departments, quality systems, or business processes.
• Participate in governance forums, quality councils, and site escalation meetings, as required.
• Translate Quality and site business plans into measurable deviation-management objectives, priorities, resource plans, and performance expectations.
• Partner with management to forecast, secure, prioritize, and allocate the resources required to support timely investigation completion, CAPA execution, and program deliverables.
• Support the implementation and optimization of electronic quality management systems.

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental & vision coverage, and life & disability insurance
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed