Senior Customer Quality Operations Professional

Role Summary

The Senior Customer Quality Operations Professional is the primary quality-support lead for Pfizer CentreOne contract manufacturing customers at the McPherson site, handling both new business and commercial accounts. The role requires supporting multiple customers, coordinating with site SMEs, and representing Pfizer professionally. The position functions within the Quality Assurance Internal & External Supply Group to ensure quality across the site, suppliers, and contracted customers, acting as Project Lead for Quality Systems and driving team-wide process improvements. It also includes oversight of Customer Quality Operations Professionals and cross-functional collaboration to ensure delivery of quality product.

Responsibilities

• Lead discussions with customers on Quality aspects of manufacturing processes for assigned Pfizer CentreOne customers, including supplier qualification, manufacturing, packaging, lab testing, release, shipping, market distribution, complaints, regulatory filings, and market action.
• Serve as Quality Project lead for contract reviews, creation of quality technical agreements, and assurance of site capabilities relevant to quality processes; identify issues for escalation and support initial quality audits.
• Oversee Continuous Improvements for Customer Quality Operation Professionals and drive performance.
• Lead Quality resources for new customer due diligence meetings and quality audits.
• Assess quality of all new customer proposals.
• Develop and trend quality metrics for each customer; lead improvement initiatives based on metrics and implement improvements with customers.
• Draft, negotiate, and obtain approval of Quality Technical Agreements; ensure terms are met and periodically reviewed/updated.
• Provide support for and coordinate customer manufacturing investigations, including scope assessment, data input, quality impact, escalation, and approval.
• Track and close manufacturing investigations, change requests, and CAPAs for customer-specific records; manage quality escalation and issue resolution.
• Support and participate in customer audits and regulatory inspections; lead projects between customers and plant quality functions for assigned customers.

Qualifications

• Required: Bachelor‚Äôs degree with at least 2 years of experience; or Master‚Äôs degree with more than 0 years; or Associate‚Äôs degree with 6 years; or high school diploma/equivalent with 8 years of relevant experience.
• Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards.
• Strong oral and written communication, presentation, and interpersonal skills.
• Working knowledge of PC and software (MS Office).
• Strong analytical skills; ability to organize and analyze data from multiple sources and extract key information to achieve goals.

Education

• Bachelor‚Äôs degree (or higher) as specified in qualifications above; applicable degrees in related fields preferred.

Additional Requirements

• Physical/Mental Requirements: Ability to stand and sit for extended periods; work in an office setting with computer use; ability to walk throughout the site to support regulatory inspections; strong interpersonal skills for independent and team work; required training for controlled environments.
• Non-standard Work Schedule, Travel or Environment: Ability to multi-task across capabilities, manage multiple priorities, and work beyond core hours, including weekends/holidays if needed; travel <20% may be required; hybrid work location.