Be an Early Applicant
We’re in relentless pursuit of breakthroughs that change patients’ lives.
The Role
Manage and approve QA activities to ensure cGMP/GDP compliance across manufacturing and labs. Lead investigations, change control, risk assessments, validation reviews, and inspection readiness. Provide technical guidance, drive corrective actions, and coordinate cross-functional quality resolutions.
Summary Generated by Built In
Use Your Power for Purpose
Responsible for independent management, review, and approval of Quality Assurance activities. Ensures implementation of quality systems, drives regulatory compliance, leads investigations, and collaborates with cross-functional teams to maintain cGMP standards and inspection readiness.
What You Will Achieve
Role Responsibilities:
Core Responsibilities:
Quality Operations
Quality Compliance
Quality Investigations
Leadership & General Responsibilities
Here Is What You Need (Minimum Requirements)
Preferred Requirements
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Responsible for independent management, review, and approval of Quality Assurance activities. Ensures implementation of quality systems, drives regulatory compliance, leads investigations, and collaborates with cross-functional teams to maintain cGMP standards and inspection readiness.
What You Will Achieve
Role Responsibilities:
- Strong knowledge of manufacturing processes, quality control, and validation activities (process, cleaning, analytical methods, equipment, utilities)
- Advanced technical document review and approval capability
- Expertise in change control and risk assessment
- Strong knowledge of chemical and microbiological testing
- Knowledge of investigations tools and root cause analysis methodologies
- Understanding of manufacturing operations, engineering, and validation systems
- Experience in handling regulatory inspections
- Accountability: Self-driven, proactive, and responsible for quality outcomes
- Critical thinking and strong compliance mindset
- Strong time management and problem-solving abilities
- Interpersonal Skills: Builds strong cross-functional relationships and communicates effectively across all organizational levels
- Decision Making: Makes timely, independent, and risk-based quality decisions
- Leadership Skills: Provides guidance, coaching, and technical direction to team members
Core Responsibilities:
Quality Operations
- Review and approve QC documents (BQ, CQ), batch records, validation protocols, and reports
- Review and approve SOPs, specifications, STPs, and study protocols
- Review stability reports, APRs, and trend reports
- Ensure manufacturing quality compliance and adherence to procedures
- Participate in Site Change Review Committee (SCRC) and assess critical changes
- Provide quality oversight for manufacturing and laboratory operations
Quality Compliance
- Ensure implementation and effectiveness of Quality Management Systems (Change Control, CAPA, Deviations)
- Lead audit and inspection readiness activities (internal, regulatory, corporate)
- Interface with regulatory agencies and support inspections (USFDA, MHRA, etc.)
- Ensure compliance with cGMP, GDP, and global regulatory requirements
- Drive quality culture and continuous compliance improvements
- Review and approve quality system documentation and risk assessments
Quality Investigations
- Lead, review, and approve deviation investigations and CAPA
- Ensure robust root cause analysis and effective corrective/preventive actions
- Drive timely closure of investigations and escalation of critical issues
- Utilize advanced investigation tools and methodologies
- Ensure investigation quality meets regulatory expectations
Leadership & General Responsibilities
- Provide technical guidance and mentoring to junior team members
- Coordinate with cross-functional teams for resolution of quality issues
- Present critical quality decisions to leadership
- Identify process improvement opportunities and drive efficiency initiatives
- Ensure timely closure of action items and commitments
- Report and escalate critical non-compliance issues
Here Is What You Need (Minimum Requirements)
- B. Pharm/M. Pharm/M.Sc.
- Master's Degree: 4 - 5 years
- Bachelor's Degree: 6 - 8 years of experience in Pharma / Biotech Quality Assurance / Quality Control / Compliance / Investigations of sterile dosage manufacturing facility
- Change Management process
- Risk assessments principles and tools
- Validation of lab equipment's
- Drug Product Process validations
- Regulatory requirements
- Compendial Changes
- Knowledge on Regulatory Guidelines, Good documentation practices and good manufacturing practices.
- Adhering to Site Procedures and corporate polices
Preferred Requirements
- Strong Interpersonal skills
- Ability to communicate effectively with all levels within the organization.
- Compliance driven approach, knowledge on cGMP and regulations.
- Should face national and international inspections such as USFDA, MHRA, TGA & WHO
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Skills Required
- B.Pharm, M.Pharm, or M.Sc. degree
- 4-5 years (Master's) or 6-8 years (Bachelor's) experience in Pharma/Biotech QA/QC/Compliance/Investigations at sterile dosage manufacturing facility
- Deep knowledge of cGMP and GDP regulations and global regulatory requirements
- Experience with regulatory inspections (USFDA, MHRA, TGA, WHO) and inspection readiness
- Expertise in Change Control processes and Quality Management Systems (CAPA, Deviations)
- Proficiency in risk assessment principles and tools and robust root cause analysis methodologies
- Experience in process, cleaning, analytical method, equipment and utilities validation (process and lab equipment validation)
- Experience reviewing and approving QC documents, batch records, SOPs, specifications, protocols, and reports
- Knowledge of compendial changes, good documentation practices, and adherence to site procedures and corporate policies
- Strong understanding of chemical and microbiological testing
- Ability to provide technical guidance, make risk-based quality decisions, and lead investigations to timely closure
- Strong interpersonal, communication, time management, and problem-solving skills
- Experience facing national and international inspections (USFDA, MHRA, TGA & WHO)
What the Team is Saying
Daniel
Diagnostics Launch Lead
Anna
R&D Privacy Steward
Esteban
Specialist
Pfizer
Am I A Good Fit?
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.
Success! Refresh the page to see how your skills align with this role.
The Company
What We Do
Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
Why Work With Us
We are the inventors, the problem solvers, the big thinkers — those who surmount any hurdle to deliver breakthrough medicines to the people who are counting on them the most.
Gallery
Pfizer Offices
Hybrid Workspace
Employees engage in a combination of remote and on-site work.
Typical time on-site:
2.5 days a week
Hudson Yards
Provincia de Buenos Aires
Andover, MA
Athens, GR
Chennai, IN
Collegeville, PA
Durham, NC
Groton, CT
Madison, NJ
Madrid, ES
Mumbai, Maharashtra
Rochester, MI
San Diego, CA
Seattle, WA
Tampa, FL
Center for Digital Innovation
Learn more
