Senior Project Manager – Commissioning & Qualifications Lead

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.

Senior Project Manager – Commissioning & Qualifications (C&Q) Lead

What you will do

Let’s do this. Let’s change the world! In this vital role you will be responsible for leading all C&Q activities for the AML-Puerto Rico site. This role will be also managing a portfolio of complex projects, ensuring they are completed on time, within budget, and to the highest standards of quality. This role involves developing and implementing processes, guidelines, and tools to support project success across a broad range of facilities, including cGMP manufacturing plants, laboratories, utility plants, and administrative buildings.

Specific responsibilities include but are not limited to:

• Lead evaluation of project change controls and establish the overall Commissioning, Qualification, and Validation (CQV) scope of work, including identification of system impacts, control strategies, and qualification boundaries.
• Direct development and governance of the Commissioning & Qualification (C&Q) Plan and supporting appendices to ensure alignment with project objectives, regulatory expectations, and quality standards.
• Lead development of the detailed C&Q Project Execution Plan (PEP) and integrate CQV activities with Construction, Startup, and Operational Readiness milestones.
• Establish and manage CQV organizational structure, execution strategies, and governance processes, including team roles and responsibilities, project flow diagrams, integrated schedules, document control strategy, Engineering Change Management (ECN) strategy, risk management plans, communication plans, and training requirements & strategies.
• Provide leadership and oversight for CQV resources, contractors, and cross-functional teams to ensure project deliverables are executed safely, efficiently, and in accordance with project timelines and compliance requirements.
• Coordinate with Engineering, Quality, Manufacturing, Automation, Construction, and Operations stakeholders to align CQV priorities, turnover sequencing, and operational readiness objectives.
• Oversee review of Field Turnover Package (FTOP) packages and ensure all required CQV documentation, turnover deliverables, and acceptance criteria are properly defined, tracked, and completed.
• Direct the strategy, development, and approval of commissioning and qualification protocols for equipment, utilities, facilities, and automation systems, ensuring consistency with project scope and validation requirements.
• Lead planning and coordination of facility verification activities to confirm facilities and systems meet design intent, operational requirements, and regulatory expectations.
• Provide strategic oversight of protocol execution readiness, discrepancy resolution processes, deviation management, and final system acceptance activities.
• Lead development, review, and approval of C&Q reports (CQRs) and ensure complete turnover documentation for impacted systems, utilities, and facilities.
• Direct preparation and issuance of the C&Q Plan Summary Report, including overall project status, key risks, execution metrics, and qualification readiness assessments.
• Monitor CQV project performance, identify risks and mitigation strategies, and communicate project status, priorities, and critical path impacts to senior leadership and stakeholders.
• Champion compliance with GMP, and company quality standards throughout all phases of CQV planning and execution.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Sr Project Mgr professional we seek is an individual contributor collaborative leader with these qualifications:

Basic Qualifications:

Doctorate degree and 2 years of project management regulated industry experience

OR

Master’s degree and 4 years of project management regulated industry experience

OR

Bachelor’s degree and 6 years of project management regulated industry experience

OR

Assocate’s degree and 10 years of project management regulated industry experience

OR

Hirgh school diploma/GED and 12 years of project management regulated industry experience

Beyond that, additional preferred qualifications are:

• Consistent track record in managing complex project portfolios, with the ability to prioritize tasks, manage timelines, and meet project standards.
• Strong experience leading CQV, C&Q and overseeing a diverse portfolio of critical projects.
• Experience with project management tools. PMP certification is a plus.
• Experience leading indirect resources and direct communications with vendors.
• Experience working across various functional areas, with the ability to communicate effectively at all management levels.
• Expertise in navigating and leading change in a dynamic environment with skills in negotiation, budgeting, goal setting, resource planning, and decision-making.
• Excellent interpersonal, organizational, and communication skills in both English and Spanish, with experience interfacing with executive management and multi-functional teams. Strong leadership skills in a team or matrix environment.
• Effective English written and verbal communication skills.
• Ability to travel up from 5% to 10% as per business needs.

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.

Apply now and make a lasting impact with the Amgen team.

careers.amgen.com

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Sponsorship

Sponsorship for this role is not guaranteed.

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.