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 site.
• Must be able to wear proper gowning and PPE in laboratory and manufacturing areas as required to meet GMP and/or OSHA requirements.
• Minimal travel may be required.

Work Location Assignment: On Premise

Last Date To Apply: February 14, 2025

The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits jobs-near-me.org (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

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.

Quality Assurance and Control

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