Senior Manager - Quality Assurance, Data Integrity Officer

Senior Manager - Quality Assurance, Data Integrity Officer

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The Senior Manager - Data Integrity Officer (“DIO”) is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. The role implements procedures, training, and oversight aligned with corporate policies and global regulations to maintain data integrity across manufacturing and testing processes.

• Provide oversight for risk assessment using Quality Risk Management (QRM) principles, including FMEA.
• Oversee remediation plans, retrospective assessments, and responses to regulatory audit findings related to data integrity.
• Conduct audits and gap assessments based on regulatory requirements and industry guidance.
• Facilitate risk assessments for new and existing equipment and systems; provide strategic direction for remediation.
• Develop and update procedures to ensure clear direction on data integrity principles and requirements.
• Lead data integrity training sessions to ensure awareness and compliance.
• Support change control and deviation management processes with respect to data integrity impact.
• Serve as point person during client and regulatory inspections for DI.
• Confirm validation of equipment and instruments to protect data.
• Oversee selection, validation, and implementation of software for cGMP data generation.
• Assess training program adequacy and oversee training execution.
• Comply with applicable regulations including 21 CFR Parts 11, 210, 211 and FDA data integrity guidance.

Bachelor’s degree or higher in Chemistry, Biotechnology, Life Sciences, Engineering or related field.

• At least 7 years in a regulated industry or 5 years of related technical knowledge involving data integrity with computer systems or manufacturing equipment.
• Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment, and quality management systems.
• Prior management experience preferred.
• Knowledge of cGMP environments and related Good Practice guidelines.
• Demonstrated leadership in personnel, systems, and processes.

• Strong knowledge of Data Integrity, Quality Control, Computerized Systems, and FDA guidance.
• Ability to influence management and collaborate with others.
• Strong problem‑solving and creative solution development.
• Experience prioritizing multiple projects successfully.
• Experience with pre‑submission audits and FDA data integrity.

• Collaborative mindset.
• Clear and transparent communication.
• Good judgment and problem‑solving ability.

• Good organizational and interpersonal skills with cultural awareness.
• Hands‑on approach and initiative.
• Resilient, pragmatic, and hardworking.
• Structured thinker.
• Ambitious, energetic, and driven.
• Approachable and enthusiastic.
• Flexible and adaptable.