Sr GxP Digital Systems Specialist

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 unlock the power of gene therapy to accelerate healthcare transformation.

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

The Sr Digital Systems Specialist will assist in the development and execution of Spark's GxP Digital Systems Program.

This role will lead the deployment and establish support models for GxP digital systems working directly with end users, cross functional teams and software providers.

This individual will be the hands-on expert for lab digital systems deployed to the Research & Technology (R&T) organization. They will be responsible for ensuring SDLC processes and Good Documentation Practices are followed in the delivery of digital system capabilities including in Spark's GxP Operational areas.

Systems in the scope of this role may include, but are not limited to:

• LabX
• Empower Enterprise
• Standalone computerized laboratory systems
• Any future GxP Electronic Lab Notebook (ELN), Lab Execution Systems (LES), and other lab workflow systems
• Tools and processes supporting paper-based documentation digitization
• Lab instrument and automation systems, including CDMS solutions
• Digital systems supporting Data Integrity for Technology Labs including SDMS solutions

Responsibilities

% of Time

Job Function and Description

20

Provide project and technical leadership to the GxP Digital Systems Program and ensure it will contribute to the company achieving its long-term strategic goals. Evaluate conceptual aspects of technical designs to ensure sound decisions and investments are made in accordance with business strategy and internal policy/governance and assess new innovative technologies.

20

Ensure plans are created and updated in a timely manner, communicated to relevant stakeholders, assess risks, and manage deliverables. Meet scheduled milestones to ensure project/program objectives are met in a timely manner. Collaborate with Corporate IT to ensure digital systems leveraged by Research and Technology are ideated, evaluated & selected, approved, constructed, delivered, and supported in accordance with Spark principles, policies, and standards.

5

Manage and build strong relationships with software vendors and SaaS providers and stay up to date on all system information including features/updates/patches/roadmaps.

30

Serve as the technical SME on lab systems and provide end users support as needed and address technical issues. Support any appropriate investigations and change management to support the system.

25

Identify opportunities to improve existing processes, equipment, systems, and infrastructure by both leveraging and setting industry best practices. Additionally, support Data Integrity efforts to ensure compliance across digital systems.

Education and Experience Requirements

Required:

• BS/MS/PhD in Life Science/Engineering/Compute Science or related field required.
• Minimum 5 years of experience in the Biotechnology or Pharmaceutical industry working with and supporting Lab applications
• Knowledge of GxP (GLP/GMP) requirements surrounding deployment of Digital Systems and Lab Operations
• Hands-on development experience with lab system customizations/configurations
• Experience with SDLC
• Strong GDP skills

Preferred:

• Preferred experience with SaaS deployments with a focus on configuration, API development and lab system integrations.
• Proven track record organizing and delivering applications from concept to go-live in a lab environment
• Demonstrated technical project management experience to develop project goals, budgets, deliverables, and timelines.

Key Skills, Abilities, and Competencies

• Experience with support and administration of laboratory systems
• Familiarity with lab master data management (MDM), including MDM for digital systems
• Strong understanding of lab data workflows and optimization techniques
• Ability to effectively communicate to scientific end users and provide training on lab software packages

Complexity and Problem Solving

• Leads internal teams in solving of complex problems.
• Participates in determining objectives of assignment
• Plan schedules and arranges own activities in accomplishing objectives
• The incumbent is expected to have strong follow-up and customer delivery mindset.
• The incumbent is also expected to ensure computerized system compliance with 21 CFR Part 11.

Internal and External Contacts

• Accountable to Research & Technology areas supported
• Internal Contacts - Support of Scientific business areas throughout R&T, Corporate IT, CSV, CQV, IT, QA, and GxP Digital Systems
• External Contacts - Vendor ecosystem
• role may require some travel

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $84,200 to 126,400.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.