Join the Spark Team

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable - until now.

We don't follow footsteps. We create the path.

Primary Duties

The QC System Lead will be responsible for the enhancement and implementation of phased QC LIMS system, as well as the design and implementation of any other future electronic laboratory Systems. This position will have management responsibility for individuals serving as system administrators for QC laboratory systems. In addition, the incumbent will work independently to improve data integrity, and collaborate with cross functional groups to update laboratory computer operation systems.

Responsibilities include but not limited to:

• Lead the enhancement of phase 1 QC LIMS system and implementation of multiple new phases.
• Initiate and lead the implementation of any future electronic laboratory systems.
• Closely collaborate with the QC laboratory stakeholders, end users, computer system validation, IT, and vendors to ensure that the user requirements, configuration, and validation of any electronic systems and standalone laboratory computer system meet business needs.
• Oversee the assessment of current standalone laboratory computer systems and upgrade of windows system to ensure the application sustainability.
• Interface with IT for supporting, troubleshooting, and upgrades of applications.
• Be deeply involved in and provide guidance on the implementation of QC laboratory systems.
• Manage the individuals serving as administrators for electronic systems (eg. LIMS, Empowers) and stand-alone systems.
• Work with internal stakeholders and external consultants to drive improvements in data integrity.
• Participate in regulatory inspections as a SME.

Responsibilities

40 % of Time

• Lead the enhancement and implementation of phased LIMS systems and meet organization timeline.
• Initiate and lead the implementation of any future electronic laboratory systems.
• Serve as the system administrator for LIMS, EMPOWER, and stand-alone laboratory systems to assure business continuity and data-integrity.
• Be the key member during implementation of any new laboratory systems.

40 % of Time

• Work with internal stakeholders and external consultants to drive improvement in data integrity.
• Ensure that applications meet user requirements, GxP requirements and Data Integrity requirements.
• Oversee the assessment on each instrument process map and identification of process gap, as well as the creation of future process.
• Author and review SOPs, manage non-conformance events as needed
• Support internal and external audits.

20 % of Time

• Hire and mentor system staff as needed.
• Develop and coach team members by continually growing employees through challenging experiences. Foster Sparks Culture and lead by example.
• Manage performance of team members, provide continuous and on-going performance feedback, hold every team member accountable to achieve results while demonstrating the Spark Values. Ensure individual objectives align to corporate and functional objectives.

Education and Experience Requirements

• BS degree on biological, chemical sciences, or related discipline, is required. Advance degree is preferred.
• 8+ years for BS, 5+ years for advanced degree of experience with biopharmaceutical products, biologics or vaccines required.
• Must have GMP experience.
• Supervisory experience is preferred.
• Proven knowledge on data integrity is required.
• Deep understanding on information technology and computer system is required.
• Scientific knowledge and demonstrated analytical background are preferred.
• Established experience in implementation of large laboratory electronic system is required.
• Familiar with standard laboratory instrument system, such as Softmax, Empowers.
• Experience in lab investigation and deviation is required.
• Excellent communication skill is required.
• May need some travel and weekend work