Senior Manager Quality Assurance – Major Deviations Lifecycle Team

Amgen; Juncos (PR); Hybrid; USD 150,000 - 210,000; Full time

Benefits offered by this job

Retirement plan

Medical, dental & vision coverage

Life & disability insurance

Stock-based long-term incentives

Flexible work models

Job summary

Amgen is seeking a Senior Manager of Quality Assurance to lead the Major Deviations Lifecycle Team, ensuring timely, compliant investigations and CAPAs across manufacturing, packaging, laboratory, and support operations.

The role partners with QA, QC, Manufacturing, Engineering, and Regulatory teams to drive robust investigations, continuous improvement, and inspection readiness for FDA/EMA expectations. Strong leadership and regulatory knowledge are essential.

Qualifications

• Doctorate or advanced degree with quality support experience.
• Master's or higher with quality support experience.
• Bachelor's with significant quality support experience.
• Associate's or High school with long-term quality experience.

Responsibilities

• Lead and manage the Major Deviations Team with coaching and resource planning.
• Oversee complex deviation investigations ensuring scientific and regulatory rigor.
• Ensure timely initiation, investigation, approval and closure of deviations within quality timelines.
• Lead root cause analyses and risk-based decision making for CAPAs.
• Maintain documentation in the digital quality management system (DQMS) and verify effectiveness.
• Escalate critical issues to site leadership and Quality Management.
• Collaborate cross-functionally to identify systemic issues and corrective actions.
• Monitor deviation trends and support audits and regulatory inspections.

Skills

Analytical thinking

Problem solving

Decision making

Communication skills

Presentation skills

Organization

Leadership

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma/GED

Job description

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.

Specific responsibilities include but are not limited to:

• 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.

What We Expect Of You

We are all different, yet we all use our unique contributions to serve patients. The Sr Mgr QA professional we seek is a collaborative people leader with these qualifications.

Basic qualifications:

• Doctorate degree and 2 years of quality support experience
• Master's degree and 6 years of quality support experience
• Bachelor's degree and 8 years of quality support experience
• Associate's degree and 10 years of quality support experience
• High school diploma / GED and 12 years of quality support experience

And 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 of resources. Your managerial experience may run concurrently with the required technical experience referenced above.

Beyond that, additional preferred qualifications are:

• 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.

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, we'll 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 & 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. Refer to the Work Location Type in the job posting to see if this applies.

Sponsorship

Sponsorship for this role is not guaranteed.

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.