LIMS Data Integrity Sr. Manager

LIMS Data Integrity Senior Manager – Perm – Onsite – Florida

Biotechnology Research organization seeks a high-level LIMS Data Integrity Sr. Manager with 8 years required experience focused on Data Integrity within IT related roles and regulatory environments to include either biopharma, biotech, or healthcare. This also requires 3 years in leadership, direct IT management, with an ability to lead cross departmental teams throughout laboratory/manufacturing data programs. Individual will have proven history within various regulatory environments including FDA, 21 CFR Part 11 and SOX, as they relate to data management and systems. Additionally, it is preferred that this person have prior experience supporting LIMS, Empower and SoftMax; similar lab systems will be considered. Opportunity offers extremely competitive compensation for seasoned Lab Systems Data Integrity expert, within a collaborative team environment.

USC or Green Card US work authorization required for an onsite opportunity.

We are unable to work with 3rd party recruiters on this.

Benefits

• Competitive Base Comp
• Annual Performance-Based Bonus (7%-10%)
• 401K with employer match at 4%, immediately vested.
• 3 weeks PTO (year 1) with 3 floating holidays
• 8 Company-Paid Holidays
• Company paid short and long-term disability.
• Tuition Assistance provided after 1-year of employment.
• Company-Paid to the local Tri-Rail Station if utilized.

Requirements

• US Citizen or Green Card Holder work authorization; location within the states.
• Ability to be onsite daily near West Palm Springs Florida.
• A Bachelors/Masters in related area.
• Prior experience with data management from LIMS (ideally LabVantage), Empower and SoftMax, or similar systems.
• Previous experience working in highly regulatory industries to include BioPharma, Biotech or Healthcare, and with FDA regulatory expertise.
• A history focused on strategic development and implementation of long-term data governance strategies to align with regulatory and organizational requirements.
• Deep understanding of Lab/IT Systems and Data Management technologies to effectively leverage these tools ensuring data integrity and compliance.
• A history in leading cross-functional teams while focusing on collaboration to foster a culture of continuous improvement and shared data integrity responsibilities.
• The ability to motivate and guide teams to achieve excellence and adhere to data integrity best practices, while setting a clear vision on data and systems initiatives moving forward.
• Familiarity with cloud-based solutions regarding data integrity maintenance are also desired to include troubleshooting technical challenges and knowledge of security protocols and regulations.
• Expertise within data flowing from lab systems to MES and SAP systems are a plus.
• Certifications in data governance, regulatory compliance and information security are desired (CISSP, CISA, CDMP).

Responsibilities

• Managing organizational Data Integrity Program to include various IT Systems and LabVantage LIMS, Empower and SoftMax.
• Overseeing 6 direct reports within data integrity team to include guiding, mentoring and delegation of tasks to achieve results.
• Leading the development and implementation of technology driven data governance strategies, while guaranteeing integrity and compliance of all digital data throughout organizations systems.
• Overseeing, implementing, and maintaining cGMP applications throughout full SDLC.
• Guaranteeing maintenance and accuracy, quality, and security of data within a highly regulated environment.
• Leading the creation/execution of data governance to include policies, accuracy, and security across IT systems within manufacturing, laboratories, and quality.
• Overseeing data management practices within technology systems to ensure full compliance within FDA, SOX, and other regulatory standards. Also guaranteeing digital/automated data meets industry requirements for integrity and reliability.
• Performing Data Integrity Audits of IT Systems to include software applications, databases, and digital workflows, while ensuring data integrity risks or discrepancies are addressed and managed accordingly.
• Performing maintenance and system administration for LabVantage LIMS, SoftMax and Empower as well as other laboratory systems, as required.
• Developing and delivering IT and cross-functional team training programs while ensuring understanding and adherence to data integrity best practices within context of regulatory and IT systems compliance.
• Overseeing and ensuring IT documentation management is maintained, accurate, accessible, and within regulatory standards to therefore align with regulatory requirements and organization operational goals.
• Participating in compliance reviews, to prompt reporting of any potential issues and provide ongoing education on relevant FDA requirements.