Manager QA Validation
Manager QA Validation
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Job Description
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 engineeringand 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 Pfizers 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 associates degree with 8 years of experience; OR a bachelors degree with at least 4 years of experience; OR a masters 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 2025
- Referral Bonus Eligibility: YES
- Eligible for Relocation Package: NO
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 providers 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.
Required Experience:
Manager
Employment Type
Full-Time
