Associate Manager (Quality Assurance – Operations/ Compliance/ Investigations)

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.