Sanford, North Carolina, United States
8 hours ago
Manager QA Validation

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.  

What You Will Achieve

In this role, you will:

Represents Sanford Quality for all technical transfer activities at site

Manages Change Management responsibilities, deliverables, and metrics within the team to ensure compliance with Pfizer standards and metrics

Appropriately manage team workload to drive project timelines in a compliant manner, based on experience, knowledge, and history of previous projects.

Review and approval of site documentation including but not limited to, change controls, cleaning/process/equipment/laboratory validation, data records, SOPs, automation, engineering and maintenance document and technical reports associated with clinical and commercial processing and ensuring adherence to regulatory agency requirements, ICH Guidelines, Pfizer Quality standards, policies and values in a timely manner

Holds self and the QA Validation team accountable for making decisions, deriving solutions or driving improvements for the areas in scope.

Ensure project quality representation has the appropriate skill set and qualifications to provide quality and compliance perspective, as well as drive completion of QA Validation team deliverables as defined by project timelines

Independently able to resolve complex issues and represents Quality Assurance in cross-departmental/cross-site/cross-network meetings/summits

Collaborates and independently engages with a wide range of co-workers, customers and management within the business unit to gather input needed to effectively manage and make timely decisions

Be accountable for the Good Data Management and Data Integrity understanding and performance of their team

Responsible for knowing, understanding, role modeling, coaching, and ensuring others embody Pfizer’s values and behaviors

Support QA VAL teams as needed with product and equipment validation needs

Provide quality consultation support for quality related issues in manufacturing operations, as needed

Here Is What You Need (Minimum Requirements)

Applicant must have a high school diploma (or equivalent) and 10 years of relevant experience; OR an as associate's degree with 8 years of experience; OR 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.

This position requires a combination of experience in positions within Technical Services and/or Development and Technology Transfer, Quality Assurance, Manufacturing; with experience as a People Leader with direct reports in one or more of those areas

Knowledge of applicable local and global regulatory requirements, cGMPs, and other applicable regulations for the product portfolio in the site, product specifications, technical standards such as international compendia, company policies and procedures, including personnel management

Strong critical thinking skills and a proactive approach

Ability to collaborate effectively, manage relationships, and communicate well both in writing and verbally

Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM, Quality Tracking System Trackwise, and Documentum platforms

Bonus Points If You Have (Preferred Requirements)

Experience in Quality Systems in pharmaceutical, medical device, or combination product industry

Knowledge or exposure to data science

Strong leadership and team management skills

Ability to work under pressure and meet tight deadlines

Ability to influence and negotiate with stakeholders

Experience in conducting internal audits and supporting regulatory inspections

  
 

Physical/Mental Requirements

Anticipates potential problems and proactively sells solution

Decision making based on facts while incorporating corporate values 

Decisive and willing to take calculated risks 

Can convert innovative insights into practical solutions

Acts as a catalyst of change and stimulates others to change

Challenges the status quo and champions new initiations

Non-Standard Work Schedule, Travel or Environment Requirements

Work schedule is 1st shift, Monday - Friday, may include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.Limited travel for the position; no more than 15% traveling.


Work Location Assignment: On Premise

OTHER JOB DETAILS

Last Date to Apply for Job: July 11th, 2025Referral Bonus Eligibility: YESEligible for Relocation Package: NO

The annual base salary for this position ranges from $102,900.00 to $171,500.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15.0% 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 | (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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