Senior Manager, Planning and Production Solutions—Label Operations
Pfizer
Groton, Connecticut
Full-Time
$124,400
HybridManager
ROLE SUMMARY
Clinical Supply Operations (CSO) is part of Clinical Development & Operations (CD&O) Global Clinical Supply (GCS) Group.
You will provide labelling and clinical supply system support for packaging and labelling operations, ensuring high-quality label design, production, and delivery to support clinical studies and patients. You will be responsible for enabling compliant, timely execution across supply chain systems while helping maintain inspection readiness and high operational quality.
You serve as a subject matter expert within label operations, applying deep supply chain and system knowledge to oversee label creation in line with GMP and regulatory requirements, while driving mid- to long-term operational strategies. You will advance label system capabilities, improve processes, and enhance overall operational efficiency within the label operations team.
KEY RESPONSIBILITIES
Serve as a subject matter expert in PRISYM360, Phrase Library administration and other labelling and inventory systems, providing end‑to‑end oversight and execution of label design, approval, printing, re‑printing, inspection, and inventory management, ensuring compliance withGood Manufacturing Practices (GMP) and applicable Regulatory Requirements.
Apply technical expertise across CSO enterprise systems (e.g., EMD365, CSDS, Clementine, PRISYM360) to execute packaging, labelling, and distribution (P/L/D) activities and ensure delivery of high-quality clinical supplies.
Define strategy, and lead the generation, execution and approval of complex label designs, reports, and print requests for internal operations and external vendors, including support for Trial Master File documentation.
Proactively monitor evolving clinical regulatory requirements, assess impacts to existing procedures and practices, and lead the implementation of new global standards and technologies to enhance identification and traceability of our clinical trial supplies across CSO supply chain enterprise systems all the way to sites.
Continuously evaluate processes and drive improvements within P/L/D enterprise systems and the associated operating model to enhance efficiency, quality, and compliance. As a subject matter expert, the PPS Senior Manager is also responsible for advancing andoptimizingCSO operational processes.
Support metrics and KPIs development and operational reporting to ensure data accuracy, consistency, and inspection readiness.
Collaborate with Global Clinical Supply (GCS), Partner Lines and external vendors to understand trial specific label design requirements and execute P/L/D transactions in CSO system, enabling timely delivery of clinical supplies to support clinical studies and patients.
Participate in CSO and GCS operational compliance and inspection readiness.
Develop ideas in line with Pfizer Purpose Blueprint and AI initiatives, translating concepts into practical solutions that support long-term strategic objectives.
Drive the organizational roadmap by identifying high-value AI use cases that strengthen business resilience and innovation.
Effectively manage and execute P/L/D workload using strong project management practices, proactively identifying risks, creating plan, and execute operations in line with portfolio, study and patient needs.
Build and maintain strong collaborative relationships with internal stakeholders and external partners including vendors, to identify opportunities for process improvement, implement innovative solutions, and lead continuous improvement initiatives aligned with PPS and CSO priorities.
MINIMUM QUALIFICATIONS
MBA, MA/MS with a minimum of 5 years related clinical supply operations experience
Bachelor’s degree with a minimum of 6 years of related clinical supply operations experience
Experience with a clinical supplies labeling and content management system
Strong working knowledge of complex clinical study designs, GMP documentation and regulatory requirements.
Strong project management and prioritization skills within Clinical Operations Supply environment.
Strong communication skills—written, verbal and presentation
Strong customer relations and negotiation skills
Experience achieving results as an individual contributor and through project teams
Proficient in Microsoft Office programs.
PREFERRED QUALIFICATIONS
Experience with PRISYM360 clinical labelling system
Clinical Pharmacy and/or Clinical Regulatory experience
Experience managing operations
Lean or Six Sigma training
Experience with supply chain enterprise systems
PHYSICAL/MENTAL REQUIREMENTS
None
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Work Location Assignment: Thisis a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
Sunshine Act
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Logistics & Supply Chain Mgmt