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

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Quality Assurance and Control