Associate Manager (Quality Assurance – Operations/ Compliance/ Investigations)
- India - Vizag
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:
- 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 ControlBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
“Breakthroughs” - These are the innovations, scientific and commercial, that we seek to deliver every day. All colleagues, regardless of role, level or location, strive for breakthroughs every day.
“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
“Patients’ lives” - We consider not only patients, but everyone they touch—including their families, caregivers, and friends—and everything they love to do. It’s an intentionally holistic view.
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.
Every decision we make and every action we take is done with the patient in mind—and to nurture an environment where breakthroughs can thrive.
Our Values
To fully realize Pfizer’s purpose, we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
Joy: We give ourselves to our work, but it also gives to us. We find joy when we take pride, recognize one another, and have fun.
Pfizer Global Supply
Pfizer Global Supply proudly shoulders the responsibility of manufacturing and distributing our wide-ranging pharmaceutical products.
With an unwavering commitment to ensuring the availability and accessibility of these life-saving medications, we play a pivotal role in reaching patients, healthcare professionals, and markets across the globe.
Our network of state-of-the-art manufacturing facilities, strategically located distribution centers, and streamlined logistics systems enables us to deliver Pfizer's medicines with utmost efficiency and reliability, making a tangible difference in patients' lives worldwide.
Benefits at Pfizer
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues. Our Pay for Performance Philosophy and Practices reward colleagues based on the contributions they make to our business.
Our Competitive Benefits Programs help our colleagues by:
- Promoting Health and Wellness to help colleagues maintain and improve their physical and mental wellbeing. Pfizer offerings include health and disability insurance, preventative health programs, medical screenings, free or reduced-cost vaccinations, discounts on Pfizer products, mental health support, nutrition and fitness counseling and more.
- Strengthening Colleagues’ Financial Security by providing company contributions to retirement plans, life insurance and financial planning education to help colleagues achieve their financial goals.
- Providing Benefits and Time off for the Moments that Matter to ensure Pfizer colleagues have the time away from the office to recharge, recover and return to work as the best version of themselves. Vacation, Holiday time and Sick time are just the beginning, with a 12 week parental leave policy for both parents of a new born, 10 day of caregiver leave for those times when your family needs you whether it’s a child, spouse or parent, bereavement leave, and additional country-specific programs.
- And so much more, depending on your country and site, Pfizer offers childcare facilities or discount programs, on-site health and/or fitness centers, movement and mindfulness solutions, “Log in for your Day” work flexibility and so much more.
For U.S. based jobs, view an overview of Pfizer’s U.S. benefits program (opens in a new window)