Quality Risk Management Manager

Use Your Power for Purpose

Every day, everything we do is driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.

Role Summary:

Provide leadership and direction for Quality Risk Management (QRM) program at the Rocky Mount, NC Site.  Act as or support the Local Process Owner (LPO) to ensure that the QRM Program is in alignment with global policies and applicable regulations.  Collaborate with teams of Subject Matter Experts (SMEs) to facilitate Quality Risk Assessments (QRAs) and support site practices.  The role will be accountable for the ownership, training, system health and continuous improvement (CI) of the Site QRM Program in alignment with Pfizer global policies and regulations.

What You Will Achieve

In this role, you will:

• Lead the Quality Risk Management (QRM) Program for the Site to assure compliance with the Pfizer global policies and regulations.
• Ensure that all aspects of the QRM Lifecycle & Program are implemented and functioning properly within the Site’s Quality Systems (including Risk Assessment, Risk Control, Risk Review and Risk Communication).
• Manage the deployment of Risk Facilitators and QRM training needs (including QRM tools).
• Act as a Change Agent with Global and Local QRM process Stakeholders.  Influence QRM Global Process Owners (GPOs), Site LPOs across the Network and Site colleagues to advocate for QRM best practices.
• Provide guidance, direction and governance to QRM teams and leaders to assure consistent application of QRM principles.
• Design and implement QRM tools to address full range of emerging needs and applications.
• Maintain QRM repositories, including lifecycle management of approved Quality Risk Assessments (QRAs).
• Act as the Subject Matter Expert (SME) for QRM to support audits and inspections.  Provide strategic direction for responses to audit QRM/QAR topics.
• Lead and maintain Site QRM Local Work Instructions (LWIs) according to the Global Document Management Procedures and collaborate with GPOs, as applicable.
• Lead Site implementation, monitoring and continuous improvement of the QRM practices.  Identify site colleague training requirements, establish/lead process governance and track local Key Performance Indicators (KPIs).

Here Is What You Need (Minimum Requirements)

• Applicant must have a Bachelor's degree with at least 4 years of experience; OR a Master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR an Associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
• Demonstrated ability in developing scientific reasoning and problem solving with minimal coaching, as well as excellent written and oral communication skills. 
• Excellent negotiation skills and be able to frequently resolve issues with a focus on QRM. 
• Demonstrated skill in developing solutions and will do so with a flexible approach to the development of options. 
• Ability to work both independently and in partnership with others; proven ability to use initiative and drive to achieve results.
• Attention to detail.
• Mastery of core computer software/systems (Word, Excel, PowerPoint, etc.).

Bonus Points If You Have (Preferred Requirements):

• At least 2 years of experience with like industry-related QRM.
• Understanding of sterile product manufacturing.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously

PHYSICAL/MENTAL REQUIREMENTS

• Mathematical calculation and complex data analysis ability.
• Occasionally lift a computer system and/or instrument up to 50 pounds.
• Use a computer terminal for up to 8 hours per shift, work around moving equipment.
• Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Primary work schedule is Day shift, Monday – Friday but evenings, weekends and holidays will be required, as needed to support manufacturing processes at the Rocky Mount s