Front Line Leadership is primarily tasked with departmental decisions and output on activities related to quality, operations, and the business. They are accountable to Senior Leadership and Directors for their department or functional area and are the technical experts.

Front Line Leadership functions include managing departmental resources appropriately, assessing performance, providing feedback, and identifying gaps. Front Line Leadership also must be skilled communicators, able to convey clear expectations, listen for feedback, and provide updates in a timely manner.

Primary Function
  The Computer System Validation Manager manages validation staffing and task execution for the validation of computer system applications, IT infrastructure, and computer system hardware. The Computer System Validation Manager works with management, especially the Computer System Applications, Information Technology, and Quality Assurance departments, to establish the philosophy for validation approaches to computer systems and IT infrastructure. The information technology manager will work with Information Services management to establish the strategic direction for the department including establishing departmental independence for assessments.
Essential Job Functions/Duties
Manage a team of professionals (computer software validation specialists, computer software validation engineers, data governance analysts, etc.) to drive validation activities for computer systems and IT infrastructure. Lead budgeting and planning for outsourced qualification and validation activities for computer systems and IT infrastructure.

Ensure change controls and validation tasks are being completed on time and meet the expected quality standards.

Review computer system and IT infrastructure qualification and validation activities (e.g. VPPs, RAs, IQs, OQs, PQs, VSs, etc.) as needed.

Work with Quality Assurance to ensure alignment for an agreed upon state of control for computer systems and IT infrastructure including data integrity controls.

Develop, or lead development of, IT Change Management and Validation Summary Reports.



Knowledge, Skills, and Abilities
Leadership Skills & Abilities
Understands the departmental budget, is aware of the impact of related expenses on the budget, and manages accordingly to ensure budget is not exceeded.

Primarily responsible for departmental 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 appropriate senior managers and/or directors.

Enforces and exemplifies company policies.

Ability to present complex information 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 all stated responsibilities including progress, accuracy, and timely completion of objectives.

Is a critical thinker with proven problem-solving and decision-making abilities.

Ensures direct reports maintain focus on our customers.

Exhibits well-developed prioritization, planning, organization and time management skills.

Possesses the ability to develop and implement complex processes, procedures, and projects within their systems

Oversees direct reports: Creates and executes short and long-term staff development plans.

Develops and leads department staff through direct observation and active feedback on an ongoing basis.

Conducts performance reviews that hold direct reports accountable to essential job functions and departmental standards of position.

Ensures that departmental status meetings are held on regular basis and conducts monthly one on one meetings with direct reports.

Directly responsible for department/function staff resource planning.

Manages departmental resources appropriately and implements processes.

Responsible for departmental hiring decisions and participates in recruitment of staff.

Is the departmental/functional area technical expert.

Makes day to day decisions on activities related to quality, operations and the business.


Computer, Technology & Technical Skills & Abilities
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).


Leadership Traits & Characteristics
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.


Education/Qualification Requirements
Education: Undergraduate degree in Computer Science, Engineering, Information Systems, or related technical field or 10+ years direct, relevant experience in managing computer system validation to provide a comparable background.
Experience Preferred: Minimum of 6+ years’ experience in IT (Computer Systems) validation including a Master of Science degree in Computer Science or any related field or 9+ years direct, relevant experience

Minimum of 1-3 years’ experience in managing staff for validation or testing for at least one of application delivery, software development, or IT infrastructure deployment.

Minimum of 3-6 years’ experience in a Biotech/ Pharmaceutical/Med product manufacturing industry regulated by the FDA.

Minimum of 3-6 years’ experience in System Development Life Cycle (SDLC).