
Validation and Compliance Specialist- GMP/Pharma Industry
Required skills
- GMP
- Validation Master Plan
- Protocols
- Reports
- Quality Systems
- Supplier Quality Management
- Change Control
- Quality Risk Management
- Investigations
- Annual Product Review
Nice to have
- Veeva
- Kneat
- Analytical skills
- Problem-solving skills
- Time management skills
- Regulatory audits
Role summary
This Validation and Compliance Specialist role in the pharmaceutical industry focuses on ensuring product safety and effectiveness through rigorous quality and compliance standards. Responsibilities include authoring, reviewing, and approving validation documents, performing validation activities under GMP, and managing various quality systems. The role requires strong knowledge of pharmaceutical industry practices, quality systems, and data analysis, with a preference for experience in specific quality management systems and AI tools. The position is onsite and requires a high school diploma with 8+ years of experience, or an associate's degree with 6+ years, or a BS with 2+ years in the pharmaceutical industry.
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our innovative, flexible, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
What You Will Achieve
In this role, you will:
- Author, review, and /or approve validation master plans, protocols, and reports, ensuring compliance with company standards and regulatory requirements.
- Perform a variety of Validation activities in compliance with Good Manufacturing Practices (GMP) and Validation Master Plan (VMP) requirements.
- Contribute to moderately complex projects, manage time effectively, and develop plans for short-term work activities.
- Manage routine Quality systems such as Supplier Quality Management, Change Control, Quality Risk Management, Documentation, and Investigations, Annual Product Review and coordinate testing with functional groups.
- Maintain the Site Validation Master Plan and support validation as a Subject Matter Expert during customer and regulatory audits for all areas of responsibility
- Support regulatory queries, cost improvement projects, and Cleaning Validation, ensuring integration of validation schedules in production and participating in deviation investigations.
Here Is What You Need (Minimum Requirements)
- High school diploma (or equivalent) with 8+ years of experience or associate’s degree with 6+ years of experience or BS with at least 2+ years of experience in pharmaceutical industry
- Proven expertise in Good Manufacturing Practices
- Strong working knowledge of various quality systems and processes
- Familiarity with information systems such as Global Document Management System, System Application & Products, and Quality Tracking System
- Excellent verbal and written communication skills
- Ability to work independently and in a team environment
Bonus Points If You Have (Preferred Requirements)
- Strong technical knowledge with validation/qualification of pharmaceutical processes, equipment, utilities, facilities, and/or computer systems
- Experience with quality management systems like Veeva and Kneat
- Strong analytical and problem-solving skills
- Strong organizational and time management skills
- Ability to mentor and guide other colleagues
- Experience in regulatory audits and compliance
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
- Technical writing skills
Physical/Mental Requirements
- Ability to perform mathematical calculations and ability to perform complex data analysis.
- Sitting, lifting, standing and bending.
Non-Standard Work Schedule, Travel, or Environment Requirements
- Minimal travel requirements (less than 5%) are expected.
- Position requires regular onsite attendance; this position cannot be performed on a remote / telecommute basis.
Other Job Details
- Last day to apply: November 17th, 2026.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.
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Quality Assurance and Control