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Pfizer · 1 day ago

Manager, Quality Assurance (Quality Risk management)

United States - North Carolina - Sanford

Full-time

Onsite

Mid, Senior Level

$96K/yr - $160K/yr

4+ years exp

Pfizer is a leading biopharmaceutical company committed to delivering safe and effective products to patients. The Manager, Quality Assurance will drive compliance and performance excellence, overseeing the Quality Risk Management program and ensuring inspection readiness and continuous improvement initiatives. This role involves leading quality risk management principles and practices, managing QRM training, and supporting audits and inspections.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

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

Qualification

Quality Risk ManagementGMP regulationsProject managementTechnical writingCommunication skills

Required

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