Senior Manager - Quality Assurance, Data Integrity Officer

Glenmark Pharmaceuticals•Monroe, NC

11d

About The Position

POSITION SUMMARY: The Senior Manager - Data Integrity Officer (DIO) is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, as appropriate, and overseeing systems and processes to ensure complete, consistent, enduring, and accessible data is attributable, legible, contemporaneously recorded, original or a true copy, and accurate. The Senior Manager Data Integrity Office (DIO) will implement procedures, training and oversight aligned with corporate policies and global regulations to ensure the integrity of data generated to support manufacturing and testing processes. This role is responsible for all site DI Plan(s) and will collaborate across functions and sites to ensure full compliance are maintained. Additionally, the DIO will serve as an active member of the site Quality Leadership Team and the Global Corporate DI Network and will implement DI practices and procedures to meet regulatory requirements. Coordinate routine DI Surveillance, weekly DI awareness topics, and monthly reporting to the site leadership team. Collaborate with cross-functional teams for continuous improvement of processes to facilitate right first-time documentation.

Requirements

Bachelors 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
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
Leadership/Managerial attributes
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

Nice To Haves

Experience with quality control data, chromatographic systems, laboratory instruments, manufacturing equipment and quality management systems preferred.
Prior management experience preferred.
Experience working for a multi-national/multicultural organization is a plus

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
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