Quality Assurance, Senior Manager Data Integrity Officer

Location

Monroe, NC | United States

Job description

The Senior Manager Quality Assurance - 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 Quality Assurance - Data Integrity Officer 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 Senior Manager Quality Assurance - Data Integrity Officer 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.

Education

• Bachelor’s degree or higher in Chemistry, Biotechnology, Life Sciences, Engineering or related working experiences.

Experience

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

Knowledge & Skills

• 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

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.

Other requirements

• Fluent English speaker
• Strong team ethic, assertive, mature and good influencing skills
• 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

Job tags

Salary