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.

• 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

• 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.

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.

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Sponsorship

Sponsorship for this role is not guaranteed.