Job Summary:

Contract/ Associate Director of IT Infrastructure and Operations - Pharmaceutical Job Description Contract / Associate Director of Infrastructure & Operations is responsible for core infrastructure platforms for a start-up organization. This role is a hands-on role that will actively create, draft, and maintain systems as well as oversee multiple functional areas including servers, storage, databases, virtualization, networking, engineering services and labs, data centers and infrastructure operations. By driving continuous improvement in service delivery and cost, this role will promote a customer-centric organization culture, and a service-oriented mindset focused on expanding technology infrastructure capabilities and delivering scalable, secure, and agile technology infrastructure.

Responsibilities:

• Create, draft, maintain, support, define and execute the IT infrastructure and operations strategy aligned with business objectives.
• Support the design implementation and management of enterprise wide IT systems networks and cloud solutions.
• Must be comfortable with configuring, coding and developing systems.
• Evaluate emerging technologies to enhance scalability security and performance.
• Develop and manage day-to-day IT operations ensuring high availability performance and reliability in conjunction with the Sr Director of Infrastructure and Operations.
• Manage and optimize IT service management processes such as incident problem and change management.
• Drive automation and efficiency improvements in IT operations.
• Work closely with Sr Director of Infrastructure and Operations and security teams to enforce security best practices and disaster recovery plans.
• Manage cloud migration initiatives (AWS, Azure).
• Manage hybrid cloud environments and optimize infrastructure for cost and performance.
• Support DevOps and site reliability engineering best practices.
• Ensure IT infrastructure and operations comply with GxP, FDA 21 CFR part 11, HIPAA, and ISO 13485 requirements.
• Validated systems to support electronic records and electronic signatures.
• Work closely with QA regulatory and compliance teams to align its practices with industry regulations.
• Support vendor qualifications and audits for IT systems used in GxP environments.
• Maintain comprehensive documentation and SOPs for IT processes to meet audit requirements.
• Negotiate and manage contracts with vendors service providers and cloud providers.
• Optimize software hardware and licensing expenditures.
• Contribute to the culture of continuous improvement innovation and collaboration.

Required Skills

• Bachelor degree (or experience) in Computer Science, Information Technology, or related field.
• 7 plus years of IT experience with at least 3 to 5 years in leadership roles overseeing IT infrastructure and operations.
• Hands on experience in configuring and developing infrastructure systems. This is not just management but hands on development activities.
• Strong experience in regulated environments (Pharmaceutical, Biotech, Clinical or Medical Device industries).
• Strong understanding of GXP, FDA 21 CFR part 11, HIPAA, GDPR, and ISO 27001 compliance.
• Proven track record managing enterprise IT infrastructure including data centers, cloud, networking, and cyber security.
• Experience leading multi-site and global IT operations in a pharmaceutical R&D, manufacturing, or clinical setting.
• Demonstrated ability to lead digital transformation initiatives including cloud migrations, automation, and IT operations.
• Strong vendor management skills including contract negotiations with cloud providers, IT service partners, and managed services organizations.
• Strategic thinking - ability to align IT infrastructure and operations with business and regulatory needs.
• Collaboration and communication - ability to work across R&D, clinical, manufacturing, regulatory, and commercial teams.
• Problem solving - strong analytical skills for troubleshooting complex IT and operational challenges.

Nice to Have:

Relevant certifications (preferred but not required): ITIL (Information Technology Infrastructure Library), CISSP (Certified Information Systems Security Professional), AWS or Azure Architect certifications.

Work Location: Place of employment is expected to be 90% remote. For all remote meetings, all employees are required to be on-camera with appropriate business casual attire and background. On occasion, some travel to client locations or company meetings may be required. Travel will be no more than 10%.

Physical Requirements: This position requires the ability to remain in a stationary position, often standing or sitting for prolonged periods. The ability to move about to accomplish tasks. Adjusting or moving objects up to 20 pounds in all directions. Communicating verbally and written word with others to exchange information. Exposure to a standard office environment with average room temperatures with no adverse environmental conditions expected.

Slipstream IT is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation or identity, national origin, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Slipstream IT makes hiring decisions based solely on qualifications, merit, and business needs at the time.

This job description may not be inclusive of all assigned duties, responsibilities, or aspects of the job described, and may be amended at anytime at the sole discretion of the Employer.