Job Details

Data Integrity Manager

The Data Integrity Manager will be responsible for ensuring flawless data management and compliance across our Greenville site. This outstanding opportunity allows you to lead a multidisciplinary team, ensuring the highest standards of data integrity in both cultural and technical aspects. You will be instrumental in implementing and maintaining compliance with 21CFR Part 11 and Annex 11 regulations. Join us to make a significant impact on our operations and drive outstanding data integrity initiatives!

Key Job Responsibilities

• Prepare and facilitate Site Governance Team meetings.
• Provide detailed metrics to site leadership using systems like TrackWise, Power BI, and other site management tools.
• Monitor equipment and instrumentation to ensure strict compliance with 21CFR Part 11, Annex 11, and other regulatory guidelines.
• Lead and support Data Integrity initiatives, proactively improving the site's data integrity culture.
• Coordinate and track the Data Integrity Remediation Plan, ensuring all commitments are successfully met.
• Develop and deliver Data Integrity awareness training.
• Build and maintain procedures aligned with data integrity regulations.
• Coordinate the DI Surveillance program to ensure compliance with documentation standards.
• Collaborate on multidisciplinary projects to meet customer, business, and regulatory requirements.
• Present DI Metrics to site leadership monthly.
• Approve DI-related deviations, CAPA, and change controls.
• Assist in data integrity risk assessments.

Job Scope

• Engage in meetings with cross-functional groups to discuss data integrity.
• Ensure operations and laboratories align with regulatory requirements.
• Apply professional concepts to resolve technical issues and lead critical initiatives.
• Network with key contacts and the Global DI network.
• Lead and influence teams regarding financial, equipment, standards, and resource needs.

Qualifications

Education:

• Bachelor's Degree required, preferably in Science, Engineering, or related fields

Experience:

• Minimum of 8 years of experience with a Bachelor's degree, or 6 years with an advanced degree, in quality and data integrity.
• Experience with TrackWise and training preferred.
• Project Management, Supervision, or Management experience required.

Knowledge, Skills, Abilities:

• Proven knowledge of cGMP and cGDP.
• Experience with 21CFR Part 11/Annex 11 compliance and TrackWise.
• Proficiency in Microsoft Office Suite.
• Strong written, interpersonal, and presentation skills.
• Ability to manage multiple projects simultaneously.

Physical Requirements:

• Ability to move about office locations and perform physical tasks as needed.
• Dexterity for typing and using a computer.
• Visual acuity for reading materials and operating equipment.

We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects. Come be a part of the team!