Senior Customer Quality Operations Professional

Use Your Power for Purpose

The Senior Customer Quality Operations Professional is the sole responsible colleague for providing quality support related to PGS McPherson Pfizer CentreOne contract manufacturing customers. Responsible for both new business and commercial accounts.  Colleague will be required to support multiple customers, can multi-task through each customer issue/requests, work with site SMEs for each activity as needed and represent Pfizer in a professional manner.

This position functions as a member of the Quality Assurance Internal & External Supply Group that supports quality assurance for the site, suppliers that support the site and Customers that the site contract manufactures for. This individual will act as Project Lead for Quality Systems to collaborate with customers and cross-functionally throughout the facility to ensure delivery of Quality Product for our Customers.  This role will also have additional responsibilities to drive systems for the team and act as oversight for Customer Quality Operations Professionals on the team. 

What You Will Achieve

• Lead discussion with Customers on the Quality aspects of all manufacturing processes specific to assigned Pfizer CentreOne customers. These processes include but are not limited to supplier qualification, manufacturing, packaging, lab testing, release, shipping, market distribution, complaints, regulatory filings and market action.

• Quality Project lead for all contract reviews, creation of new quality technical agreements, assurance of site capabilities as it pertains to quality processes, understanding of development activities and identification of issues for escalation and initial quality audits.

• Oversee systems of Continuous Improvements for Customer Quality Operation Professionals and additional responsibilities to drive performance.

• Lead Quality Resource for new customer due diligence meetings and quality audits.

• Responsible for Quality assessment of all new customer proposals.

• Develop and Trend quality metrics for each individual Pfizer CentreOne customers. Project lead for areas for improvement through the metrics and driving continuous improvement opportunities to present to the customers and implementation.

• Draft, negotiate, and gain approval of the Quality Technical Agreement between Pfizer and the customer.

• Ensure the terms within the agreement are met by both parties.  Perform a periodic review of the agreement and update as required.

• Provide support for and coordinate Pfizer CentreOne customer manufacturing investigations.  This will include assessment of scope, input of customer specific information/data, quality impact, escalation and review/approval.

• Perform communication, tracking and closure of manufacturing investigations, change requests and CAPAs for Pfizer CentreOne Customer specific records.

• Responsible for quality escalation and issue resolution as it impacts assigned Pfizer CentreOne customers.

• Support and participate in customer audits and regulatory inspections.

• Lead Projects between Pfizer CentreOne customers and plant quality functions specific to assigned customers.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelor's degree with at least 2 years of experience; OR a master's degree with more than 0+ years of experience; OR an associate's degree with 6 years of experience; OR a high school diploma (or equivalent) and 8 years ofrelevantexperience

• 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 required. Must be capable of organizing and analyzing data from multiple sources and extracting key information to achieve goals.

Bonus Points If You Have (Preferred Requirements)

• Previous experience in internal assessment program, auditing, and/or walkthrough audits

• Production operations and/or Laboratory knowledge preferred

PHYSICAL/MENTAL REQUIREMENTS

• Ability to stand for 1 hour a time, sit for 2 to 3 hours a time.  Require working in an office stetting where sitting and computer usage would be typical. may include walking throughout site to support Regulatory Inspection activities.

• Requires tactful, persuasive, and assertive interpersonal skills and the ability to work both independently and with teams.

• Requires training for controlled environments within the facility to help facilitate walkthroughs audits.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls.  Note that these activities may not be time bound to core hours or presence at the site.

• Must have the ability to work effectively under and manage to strict production, time and performance deadlines.

• Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.