Dir, Infrastructure Service Management

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 Director, IT Infrastructure & Service Management role is responsible for the establishment and continuous improvement of the framework of operational efficiency, service delivery, and compliance and quality of Infrastructure and Security (I&S) services.  This role is tasked with the development of IT Enterprise compliance and risk related programs and services, oversight of I&S project management, governance of Service Management/MSP partners and IT Service Management (ITSM) tools, processes and content, and the communication of key messages related to operational functions and services.

This role will monitor the overall service performance and quality provided by the Infrastructure & Security (I&S) organization and its partners ensuring that compliance, deliverables and services are aligned with departmental and business objectives and achieved with additional focus on continuous improvement.  This includes serving as the point of contact for tracking, reporting, and holding both I&S team members and its partners accountable for all agreed upon SLAs and commitments.  

This role will own and must understand contractual, commercial and operational working relationships with strategic partners to ensure effective delivery of committed goods and services.

Responsibilities

30%      Compliance & Risk

• Establish and author IT compliance related policies, procedures and related documents pertaining to Quality and continuous improvement of corporate IT computer systems.  Follows IT best practices methodologies (NIST, HIPAA).
• Provide IT support/assistance to the Computer Systems Validation group to ensure GXP computer systems follow GAMP5 guidelines.
• Ensure compliance with FDA regulations related to IT infrastructure.
• Ensure compliance with FDA 21 CFR Part 11, in partnership with the system owner and the Computer Systems Validation group.
• Coordinate and manage the IT Change Management process & Change Advisory Board, acting as IT Change Manager to ensure changes are properly documented, appropriately visible to the broader IT organization, and tracked to completion.
• Support and facilitate the training process for IT staff, both employees and contractors, including designing and delivering a training program for IT staff on policies, standard operating procedures, and computer system qualification and validation methods to meet industry standards.

30%      Service Management

• Collaborate with internal stakeholders — including IT and business resources, and procurement — to develop criteria and best practices for Strategic Partner and vendor selection.
• Collaborate with Procurement team to optimize the cost-effectiveness of negotiations and ensure ongoing adherence to contractual obligations (e.g. SLA).
• Manage vendor relationships as the key point of contact between specified vendors and the business.
• Provide visibility to vendor performance through reporting, and monthly, quarterly & annual Business Reviews
• Manage and mature ITSM platform guidelines and capabilities, ensuring that the needs of the business are incorporated into planning.
• Ensure the continuous operation of ITSM platform services and their integration into other workflows and tools, both internal & external, is optimized.

15%      Project Management

• Track and monitor the I&S portfolio and project management related activities, milestones, and delivery. 
• Partner with I&S team on resource and budget forecasting and allocation.
• Develop and implement best practices and tools for I&O portfolio, program, and project execution and management.
• Partner with functional I&S stakeholders to prioritize, validate, and track capital investments.  Draft associated business case justification as warranted.
• Establish and lead the governance process to plan, budget, execute, monitor, and close-out programs/projects within the I&S portfolio and its related services.
• Effectively communicate status including timelines, budgets, risks & issues.

10%      Communications

• Establish communication standards that can be leveraged across IT to drive consistency of messaging, including format, frequency and audience.
• Collaborate with IT Operations during planned and unplanned events to properly convey status, timing, and impact.
• Ensure Knowledge Base for both internal and user-facing needs is established, reviewed by appropriate resources, visible & available.

15%      Leadership

• Manage the IT Infrastructure & Service Management team to achieve business goals and objectives.
• Foster Spark’s Culture:  Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
• Hire & Integrate:  Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values.  Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives.  Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.

• Manage Performance:   Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing.  Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
•  Develop People:   Understand each individual team member’s career goals. strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on-the-job experiential learning and stretch opportunities.

Education and Experience Requirements

• Bachelor’s Degree with 15+ years in Information Technology
• 10+ years of combined relevant experience in pharmaceutical or health and science industry.
• 5+ years of experience in management and adherence to quality processes and systems supporting the Life Sciences industry.
• Subject Matter Expertise in IT Compliance as it relates to IT operational services and assets.
• Subject Matter Expertise in ITSM platforms such as EasyVista and ServiceNow.
• Experience in ITSM & ITIL disciplines with a dominant focus on IT Change Management
• Experience in Organizational Change Management (OCM)
• ITIL and PMP certifications a plus
• GxP Manufacturing and/or GxP Quality Control & Assurance a plus

Key Skills, Abilities, and Competencies

• Works well in a collaborative environment with the ability to influence, guide and collaborate with internal stakeholders to achieve meaningful outcomes
• Demonstrated diverse collaborative leadership experience including the ability to influence and collaborate with peers, oversee and guide the work of other colleagues to achieve goals.
• Success in improving supplier relationships with key suppliers in a spirit of encouraging business partnerships with common goals.
• Must know Pharmaceutical and Biotechnology business processes and regulatory requirements and a good understanding of IT governance concepts
• Driven with a strong sense of prioritization, accountability and personal ownership.

• Complexity and Problem Solving
• Describe the decisions made by the incumbents on a regular basis. Include decisions within the Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
• Analyzes, evaluates, and resolves complex issues and risks across multiple cross-functional groups enterprise-wide.
• Ensures compliance with regulatory requirements/controls related to business systems and IT processes.

Internal and External Contacts

• This role will regularly interface with all levels, across multiple departments, and with multiple partners, providing leadership and direction as required.

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 $172,500 to $258,700.00. 

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.