IT Manager/CSV/GMP

3 days ago


Boston, United States Azzur Group Full time
Senior Manager, Infrastructure Operations & Security (Contract/Hybrid*3 days per week in the Office)

Senior Manager, Infrastructure Operations & Security (Temp to Perm)

Reporting to: Associate Director, IT Operations, Infrastructure and Security

Do you have the passion and commitment to join a team whose mission is to develop treatments that have a clear and profound impact on people with rare diseases? Does it excite you to be a part of a company developing potential new treatments that could dramatically improve the lives of people with limited to no treatment options? Named one of the Top Places to Work by The Boston Globe, this Client is an exceptional place, focused on open communication and collaboration and dedicated to each other, our partners, and the medical community. 

With the April 2024 U.S. approval of our first drug we have made great progress in advancing our patient-centric mission and in evolving the company into a fully integrated pharmaceutical company. But there is so much left to do We are continuing to explore global opportunities for mavorixafor in its first indication, while also advancing mavorixafor for people with chronic neutropenia through an ongoing pivotal, global Phase 3 clinical trial. In addition, our research team in Vienna, Austria is focusing on new drug discovery and examining the genetic causes of chronic neutropenic disorders. 

We recognize that developing innovative, new medicines is challenging, but we embrace this challenge to truly make progress for patients each day. If you feel you would be a good fit for "The Client", we invite you to share with us your aspirations and career goals.

 At "The Client" you will find… 

  • A team that values grit and passion of innovative science.
  • The opportunity to leverage your knowledge of IT to support our innovative science and allow you to have a major impact on our mission to support our patients.  
  • A collegial environment with a team-based approach, where our mission drives our values, behaviors, and creativity.  

Your Responsibilities:

The Senior Manager of IT Operations, Infrastructure, and Security (SM IT OIS) role is to lead the smooth and secure operation of CLIENT IT systems and infrastructure. Responsible for the planning, implementing, and management of IT projects, policies, and procedures in alignment with our business goals and compliance with industry standards and regulations.

This individual will plan, coordinate, direct, and design IT-related activities of the organization, as well as provide administrative direction and support for daily operational activities of the IT department. The SM of IT OIS will work closely with decision makers in other departments to identify, recommend, develop, implement, and support cost-effective technology solutions for all aspects of the organization. This person will also define and implement IT policies, procedures, and best practices, assist with incident response, participate in compliance assessment audits, offer mitigation recommendations, and manage vendor relationships.

  • Benchmark, analyze, report on, and make recommendations for the improvement and growth of the IT infrastructure and all aspects of the IT Department, including purchasing, budgeting, and budget review.
  • Develop business case justifications and cost/benefit analyses for IT spending and initiatives.
  • Develop and implement all IT policies and procedures, including those for architecture, security, disaster, purchasing, and service provision.
  • Develop requests for proposal.
  • In collaboration with Finance Negotiate and administer vendor, outsourcer, contingent worker and service agreements.
  • Manage and monitor the performance, availability, security, and scalability of the IT systems and infrastructure, including servers, networks, cloud services, databases, applications, and devices.
  • Ensure compliance with IT policies, standards, and best practices, as well as legal and regulatory requirements.
  • Manage and maintain relationships with IT vendors, contractors, and service providers. Negotiate contracts and service level agreements.
  • Prepare regular reports on operations and infrastructure systems including Asset, Patch, and Software/Application management.
  • Operate, maintain, and dispose of information systems and network nodes in accordance with established security policies and practices.
  • Conduct regular in-house security reviews for "The Client" enterprise systems as applicable.
  • Oversee provisioning of end-user services, including help desk and technical support services.
  • Work with stakeholders to define business and systems requirements for new technology implementations.
  • Direct research on potential technology solutions in support of procurement efforts.
  • Keep current with the latest technologies.
  • oversee projects, communicate on progress.
  • Practice asset management for IT hardware, software, and equipment.
  • Establish and maintain regular written and in-person communications with the organization’s end users regarding pertinent IT activities.

What You Will Bring:

  • Bachelor’s degree in computer science, Information Systems or related discipline or equivalent education and experience.
  • Self-motivated with the ability to work autonomously in a fast-paced environment.
  • Effective organizational and prioritization skills.
  • Demonstrated management skills and understanding of project management lifecycle.
  • Strong written and verbal communications and the ability to interact with both technical and non-technical stakeholders and users.
  • Hands on security experience with computer hardware/software systems.
  • Hands on security experience in data center management and data governance.
  • Hands on security experience with computer networks, network administration and network installation. 
  • Hands on security experience in leading / coordinating / executing security compliance activities.
  • ***Experience within the biotech or pharmaceutical industry and working knowledge of Good Manufacturing processes (GMP) and Computer Systems Validation (CSV).

Working Conditions:

  • Hybrid in-office required – 3 days in office.
  • On-call availability weeknights and weekends.
  • Sitting for extended periods of time.
  • Dexterity of hands and fingers to operate a computer keyboard, mouse, power tools, and to handle other computer components.
  • Occasional inspection of cables in floors and ceilings.

Lifting and transporting of moderately heavy objects, such as computers and peripherals

Requirements

  • Experience in facilitating innovation in business process and technical solution delivery.
  • Understanding of IT portfolio management and evaluating project criteria on ROI, strategic alignment, cost savings and suitability.
  • Experience interfacing and communicating with Executives in relation to Information Technology projects.
  • Strong leadership skills.
  • Excellent written and oral communication skills.
  • Excellent interpersonal skills.
  • Ability to conduct and direct research into IT issues and products as required.
  • Ability to present ideas in business-friendly and user-friendly language.
  • Ability to perform general mathematical calculations for the purpose of creating business cases, budgets, and so on.
  • Highly self-motivated and directed.
  • Keen attention to detail.
  • Proven analytical, evaluative, and problem-solving abilities.
  • Ability to effectively prioritize and execute tasks in a high-pressure environment.
  • Exceptional customer service orientation.
  • Extensive experience working in a team-oriented, collaborative environment.

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