Glenmark Pharmaceuticals · 9 hours ago
Senior Manager - Quality Assurance, Data Integrity Officer
Monroe, NC
Full-time
Onsite
Senior Level
5+ years expGlenmark Pharmaceuticals is seeking a Senior Manager - Data Integrity Officer responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. The role involves implementing procedures and oversight aligned with corporate policies and global regulations to ensure data integrity across manufacturing and testing processes.
BiotechnologyHealth CarePharmaceutical
Hiring Manager
Gayathri Kirthivasan
Responsibilities
Provide oversight for governance, management, and coordination of activities related to risk assessment, utilizing Quality Risk Management (QRM) principles, such as Failure Mode Effects Analysis (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 as updated and issued from time to time
Facilitate risk assessments for new and existing equipment and systems and provide strategic direction for remediation
Develop, own, and update procedures as necessary to ensure clear direction and understanding of data integrity principles and requirements
Leads data integrity training to ensure awareness and compliance to data integrity regulatory and program requirements
Support the change control and deviation management processes with respect to potential data integrity impact and ensure appropriate implementation actions are carried out to maintain compliance
Serve as the point person during client and regulatory inspections for DI
Confirm new and existing equipment and instruments are appropriately validated, when appropriate, to protect data and ensure activities can be audited and reviewed at appropriate intervals
Oversee the selection, validation, and implementation of software used for the generation of cGMP data
Conduct audits and gap assessments based on regulatory requirements and industry guidance as updated and issued from time to time
Oversee the selection, validation, and implementation of software used for the generation of cGMP data
Assess training program and materials for adequacy to educate employees on expectations related to data integrity and conduct or oversee training, as appropriate
Comply with applicable regulations and guidance, including, but not limited to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance
Qualification
Required
Bachelor's degree or higher in Chemistry, Biotechnology, Life Sciences, Engineering or related working experiences
7 years in a regulated industry OR 5 years with related technical knowledge including data integrity related to computer systems / data related to manufacturing equipment, QC instruments, and support equipment/systems
Knowledge of and experience with Data Integrity, Quality, Quality Control, Computerized Systems, Good Manufacturing Practice, Good Documentation Practice, Good Laboratory Practice, and other aspects of cGMP environments
Demonstrated leadership experience over personnel, systems, and processes
Excellent knowledge Data Integrity, Quality Control, Computerized Systems Relations, Performance Management, and Learning and Development
Demonstrated ability to influence management and collaborate with others
Strong problem-solving skills; developing creative solutions to meet objectives
Demonstrated experience in prioritizing multiple projects / tasks at the same time, with successful results
Experience with pre-submission audits
Experience with FDA data integrity
Collaborative mind-set
Management experience
Clear and transparent communication style
Good judgment and problem solving ability & is capable of understanding the impact of decision making on both Glenmark and their customers
Good organizational skills with cultural awareness and sensitivity
Good inter-personal skills and with a “hands on” approach
Able to work on own initiative and as a team player
Resilient, pragmatic and hardworking
Structured thinker
Ambitious energetic and driven
Approachable and enthusiastic
Flexible and adaptable
By her/his personal example, encourage a culture of dedication and sheer hard work
Team orientated; will develop close relationships with other key internal functions
Preferred
Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment and quality management systems
Prior management experience
Experience working for a multi-national/multicultural organization is a plus
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
H1B Sponsorship
Glenmark Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2023 (1)
2022 (4)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
2025-12-24
Business Standard India
2025-12-17
Company data provided by crunchbase