Quality Assurance and Control

Use Your Power for Purpose

At Pfizer, we are driven by an unwavering commitment to delivering safe and effective products to patients. Our quality culture, grounded in science and risk-based compliance, prioritizes flexibility, innovation, and customer satisfaction. Your contributions will directly impact patients' well-being worldwide.

What You Will Achieve

In this role, you will:

• Support Post Approval Changes, initial registrations, and renewals.
• Conduct preliminary regulatory impact assessments and facilitate discussions.
• Coordinate the collection of supporting documents for regulatory submissions.
• Liaise between CMOs and internal Pfizer functions to ensure timely progression of change activities.
• Provide regulatory expertise within the Virtual Site Operating Team (VSOT).
• Support dossier compliance assessments and new regulations implementation.
• Contribute to investigations into regulatory discrepancies.
• Manage complaints for commercial Drug Product and Medical Device and Combination Product.
• Review and approve SAP material master workflow tasks.

Here Is What You Need (Minimum Requirements)

• At least 5 years of experience in a GXP setting and/or Regulatory Affairs role (or 3 years with a Master's degree).
• Expertise in Change Management and/or Regulatory Affairs.
• Experience with relevant QTS and eQMS modules.
• Knowledge of US, European, and global cGMPs, compliance issues, and industry quality assurance practices.
• Fundamental understanding of QA and GMP principles.
• Experience in quality assurance or quality control within the pharmaceutical industry.
• Knowledge of regulatory requirements and guidelines.
• Strong communication, interpersonal, and influential skills.
• Proficient in English and technical writing.
• Demonstrated success in leading projects and decision-making based on science and risk-based approaches.

Bonus Points If You Have (Preferred Requirements)

• Ability to work effectively as a team member within a matrix environment.
• Experience with supplier quality management.
• Strong interpersonal skills and ability to work collaboratively with cross-functional teams.
• Ability to adapt to changing priorities and work in a fast-paced environment.
• Experience using common AI tools, including generative technologies like ChatGPT or Microsoft Copilot.