Senior Project Manager – Commissioning & Qualifications Lead

Amgen • Juncos, PR

3d

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. 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.

Requirements

• 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.
• 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.

Nice To Haves

• PMP certification is a plus.

Responsibilities

• 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.

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