Manager, Quality Assurance (Quality Risk management)

Pfizer • Sanford, NC

1d • Onsite

About The Position

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, rooted in science and risk-based compliance, is both flexible and innovative, always putting the customer first. Whether your role involves development, maintenance, compliance, or research analysis, your contributions are vital and directly impact patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As the site Quality Risk management Lead at Sanford, you will drive compliance and performance excellence. The role will provide oversight of the application of the Quality Risk management program, technical expertise as well as drive compliance initiatives, support inspection readiness and continuous improvement projects. This position will work closely with other site operating units as well as site leadership and the above site QRM team. What You Will Achieve In this role, you will: Leads the integration of Quality Risk Management (QRM) principles and practices into the Quality System, Develops QRM Plan for site Ensures all aspects of the Quality Risk Management lifecycle and program are in place and properly functioning Manages the deployment of site risk facilitators and QRM training Participates in PCT meetings within network Supports risk management during audits/inspections Reports site QRM metrics Ensures deployment of Risk Register and QRM Maturity Assessment Provide technical inputs to evaluate QRM activities and accountable to provide leadership to drive issues to timely resolution. Lead successful and timely execution of quality and compliance improvement initiatives. Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness.

Requirements

• Applicant must have a Bachelor’s degree with at least 4 years of experience OR Master’s degree with more than 2 years of experience, OR a PhD with 0 years of experience OR an Associate’s degree with 8 years of experience OR High School Diploma (or Equivalent) and 10 years of relevant experience.
• Experience in Quality Risk Management
• Previous experience with leading projects is required.
• The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups.
• The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities.

Nice To Haves

• Experience interfacing with regulators/inspectors
• Ability to communicate effectively across diverse functional groups and layers of management.
• Strong Technical writing skills
• Able to collaborate and partner cross-functionally
• In depth knowledge and understanding of GMP regulations and Quality System requirements

Responsibilities

• Leads the integration of Quality Risk Management (QRM) principles and practices into the Quality System
• Develops QRM Plan for site
• Ensures all aspects of the Quality Risk Management lifecycle and program are in place and properly functioning
• Manages the deployment of site risk facilitators and QRM training
• Participates in PCT meetings within network
• Supports risk management during audits/inspections
• Reports site QRM metrics
• Ensures deployment of Risk Register and QRM Maturity Assessment
• Provide technical inputs to evaluate QRM activities and accountable to provide leadership to drive issues to timely resolution.
• Lead successful and timely execution of quality and compliance improvement initiatives.
• Drive compliance excellence by ensuring GMP inspection readiness for Regulatory Authorities and site inspection readiness.

Benefits

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees