Director, Information Services

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Information Services Director at Cook MyoSite, Inc. will provide information services strategies to ensure that they support the company’s goals by evaluating our existing technologies and processes and advising on the best ways to move forward with compliance, cost-effectiveness and competitive advantages.

The Director Leadership team is tasked with developing and communicating the overall strategic vision to the organization and leading the motivational drive to achieve this. Director Leadership is subordinate to the Vice Presidents in the hierarchical organization. They are accountable for making decisions and ensuring the successful completion of strategic initiatives are aligned with quality, operational, and best business practices. Director Leadership functions revolve around overseeing direct reports, creating and executing short-term and long-term staff development plans, and developing, reviewing, and enforcing company policies.

• Able to travel to Pittsburgh, PA on-site offices with travel duration typically less than 5-6 hours, with the maximum being 24 hours, and an expectation of one day a week on-site.
• Provide executive authority and responsibility over the Computer System Applications (CSA), Computer System Validations (CSV), and Information Technology (IT) departments.
• Provide executive oversight to budgeting and planning activities for the directorate. 
• Provide executive oversight for company’s manufacturing, laboratory, and business applications as managed by various CSA departments.
• Ensure CSV activities as part of the development, validation, and administration of computerized system applications and IT infrastructure are compliant with company, and parent company, policy and procedures. 
• Provide oversight for company’s Information Technology infrastructure as managed by the Information Technology department. 
• Maintain relationships with vendors, business partners, and contract/consulting agencies providing software, equipment, and staffing.
• Oversee team members and support personnel development to ensure essential job functions and duties are performed at high standards.

• Ensures directorate and reporting departments are managing and meeting annual budget.
• Responsible for the planning and the timely submission of directorate/department budget requests and considerations to the managing senior director or vice president, and finance department in accordance with the annual budgeting timeline. 
• Responsible for short and longer-term company impacting decisions and output.
• Effectively delegates and follows up on completion of work.
• Regularly and consistently provides status reports on all active projects and initiatives to Executive Leadership.
• Develops, reviews, and enforces company policies.
• Ability to present highly complex information to a broad audience in a clear and comprehensive manner.

• Is an effective communicator with internal and external stakeholders. Conveys clear expectations, actively listens to input and responds to feedback appropriately and in a timely manner.
• Is action orientated and follows up on feedback to ensure positive outcomes.
• Accountable for successful organizational outcomes and holds teams accountable for all stated responsibilities.
• Is a critical thinker with proven problem-solving and decision-making abilities. 
• Ensures company maintains focus on our customers. 
• Exhibits well-developed prioritization, planning, organization and time management skills.
• Acts as management with executive responsibility.
• Oversees direct reports: Creates and executes short and long-term staff development plans. 
• Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.
• Ensures that directorate status meetings are held on regular basis and conducts monthly one on one meetings with direct reports.
• Directly responsible for directorate staff resource planning.
• Responsible for departmental hiring decisions and participates in recruitment of staff.
• Makes decisions and ensures the successful completion of strategic initiatives that are aligned with quality, operational and business best practices.
• Develops and communicates the overall strategic vision for the organization.

• Communicates and exemplifies Cook MyoSite core values.
• Demonstrates strong interpersonal skills resulting in exceptional rapport with people. Proven success initiating, promoting and maintaining strong interpersonal relations.
• Is a teacher and trusted leader.
• Demonstrates decisiveness by making decisions in a timely manner.
• Identifies and effectively manages conflict.
• Proactively and appropriately challenges the status quo and champions change for the advancement of the organization.
• Is a positive influence within the company and supports it, and their colleagues, both publicly and privately.
• Builds a strong team and supports its progress with compassion and enthusiasm.
• Demonstrates passion for our mission even through times of challenge and adversity.
• Understands and embraces the vision and inspires others to realize it.
• Is decisive and able to employ the appropriate balance of risk taking and judiciousness.
• Promotes a healthy culture aligned with MyoSite's values. 

• Undergraduate or Master's degree in Computer Science, Information Systems, or a related technology field; or 15+ years of IT industry related experience; is required.

• Minimum of 10+ years' of experience in roles within information technology and services.

• Minimum of 7+ years’ management experience.

• Minimum 7+ years' experience as a functional manager in two or more of commercial off-the-shelf (COTS) application management, computer system validations management, IT service management, or software development management.
• Demonstratable expertise in understanding and applying FDA validation requirements for applications, computer systems, and IT infrastructure.
• Minimum of 3 years' experience managing multiple departmental managers.
• Minimum of 10+ years’ experience in at least one of biotechnology, pharmaceutical, or medical device product manufacturing.
• Minimum of 1-3 years' experience as a project or program manager. 

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook
• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

Physical Requirements:

• Hybrid position

• Office/Remote Setting (no travel): General office, warehouse and laboratory setting.

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.