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IT Director (Manufacturing and Quality)

IT Director (Manufacturing and Quality)

ID 
2017-1098
Category 
Information Technology
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

 

Under the general guidance of the Vice President, Information Technology, the IT Director is responsible for serving as the strategic interface with the Manufacturing, Supply Chain, and Quality units, for developing relationships with business stakeholders, and positioning IT as a strategic and competitive advantage for the organization. The IT Director is required to understand key business processes, maintain the strategic technology roadmap, reengineer business process, design solutions, implement systems, and manage operational support for MacroGenics Manufacturing, Supply Chain, and Quality functions.

 

Responsibilities and Job Duties

  • Provides highly-valued strategic consulting level support and guidance through key Information Technology initiatives to enhance and accelerate drug development efforts.
  • Serves as a subject matter expert on Technical, Manufacturing, Supply Chain, and Quality business processes.
  • Creates and maintains an IT strategy and roadmap, aligned to business goals and identifying opportunities where IT can bring about efficiencies, embed quality, and drive business innovation
  • Recruits, manages, mentors, and develops staff – provides specific, measurable, goals, timely feedback, and ensures that all functional resources are in alignment with the company’s vision.
  • Communicates decisions, priorities and relevant project information to appropriate levels of staff regarding business unit requests, projects and initiatives.
  • Ensures teams embrace cGxP, IT Compliance, IT Security, SOX, data privacy, and other risk management considerations, and that they are embedded in projects and operations.
  • Proactively shares knowledge of technology risks and opportunities to build competitive advantage and improve efficiency and effectiveness of business units.
  • Proactively serves as a “trusted advisor” and is the primary point of contact from the IT organizations for business line executives, managers and key contacts.
  • Represents IT in providing and clarifying the technology services and capabilities to the business.
  • Makes change management and communication plans a priority from project initiation through successful adoption of new solutions.
  • Facilitates the planning and execution of business changes through the use of technology. Supports, leads, and guides business organizational readiness and change management activities.
  • Manages the business technology and data portfolio to maximum potential and value.
  • Drives strategic assessments including vendor selections. Oversees vendor work quality and productivity while managing vendor relationships and contracting.
  • Coordinates design of the business system capabilities. Ensures that design is consistent with agreed upon business processes and provides a foundation for continuous improvement and business efficiency.

Qualifications

 

Education & Other Credentials

Bachelor’s degree in Electrical Engineering, Computer Science, Computer Information Systems, Management Information Systems or a related field

Experience

  • Minimum of 10 years of experience in biopharma technology with at least 5 years supporting Manufacturing and/or Quality.
  • Excellent knowledge of Technical and Manufacturing business processes and operations within a commercial pharmaceutical environment.
  • Knowledge and experience of GAMP, 21 CFR Part 11, Annex 11 and Data Integrity.
  • Experience of system implementation & validation within a biopharma environment.
  • Professional experience serving in a management and leadership role within an information technology service function or business process consultant.
  • Demonstrable experience overseeing planning, delivery and maintenance of a portfolio of business critical computerized solutions on time and on budget.
  • Change management experience integrating key change management principals and tools with the implementation of new capabilities preparing the business for change. In addition, monitor and drive the adoption of new business processes and support IT capabilities.
  • Vendor management experience including vendor due diligence, contracting, and performance management. Fosters partnerships and contracts which result in competitive investment for GW and maximizes the efficiency of vendor performance.
  • Financial management for projects and operations.
  • Working knowledge of the system design lifecycle, IT project management and development of validation/qualification documentation within a regulated environment.
  • Interfacing and collaborating with both technical and non-technical colleagues including IT contractors/developers, business stakeholders and customers, vendors/suppliers, at all levels including senior management and board level. 

Supervisory Responsibilities

 

No

 

Preferred Qualifications

  • Degree or background in a scientific discipline

  • Advance degree in business management
  • Background in biological manufacturing, biopharma supply chain, Quality and a broad understanding in the areas of immuno-oncology and autoimmune disorders.
  • Passionate about promoting the best possible user experience for internal customers to engage external customers, realizing operational efficiencies, improving collaboration, and/or reducing administrative burden. 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.