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