# Quality Assurance and Control

**Company**: Pfizer
**Location**: Makati City, Philippines
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Philippines---Makati-City/Senior-Associate--ESOQ-Regulatory-Operations_4964362?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_e666d3dd-f9a

## Description

## 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.

## Skills

### Required
- Change Management
- Regulatory Affairs
- GXP
- QTS
- eQMS
- cGMP
- Quality Assurance
- Quality Control
- Technical Writing
- Project Leadership
- Risk-Based Approach

### Nice to have
- Supplier Quality Management
- Cross-Functional Collaboration
- Adaptability
- AI Tools
- Generative Technologies

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Source: [Apply at pfizer.wd1.myworkdayjobs.com](https://pfizer.wd1.myworkdayjobs.com/en-US/PfizerCareers/job/Philippines---Makati-City/Senior-Associate--ESOQ-Regulatory-Operations_4964362?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)