Senior Compliance Specialist

Infosys; Indianapolis (IN); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading company in digital services seeks a Life Sciences Domain Consultant in Indianapolis. This mid-senior level role involves leading validation activities, overseeing IT compliance audits, and ensuring adherence to GxP standards. Candidates must possess strong quality compliance experience and a willingness to travel as needed.

Qualifications

• 4+ years of IT experience, particularly in an FDA-regulated environment.
• Strong analytical skills for evaluating IT risk.
• Experience with project team contributions and deliverables.

Responsibilities

• Lead validation activities for clients and manage IT audits.
• Evaluate IT quality and GxP issues, contribute to deliverables.
• Coordinate stakeholder engagements and facilitate inspections.

Skills

Quality and compliance experience

Stakeholder management

Communication skills

Education

Bachelor’s degree or foreign equivalent

Tools

MES

QMS (Trackwise)

PAS/DCS qualification

Job description

Direct message the job poster from Infosys

Job Description: Seeking a Life Sciences Domain Consultant. As a commissioning and qualification consultant, you will lead validation activities for clients and may also handle IT compliance audits, assurance, and support external inspections from regulatory bodies such as FDA, MHRA, European Health Commission, and Health Canada.

Required Qualifications:

• Candidate must be located within commuting distance of Indianapolis, IN or be willing to relocate. Travel within the USA may be required.
• Bachelor’s degree or foreign equivalent from an accredited institution; three years of progressive experience in the field can substitute for each year of education.
• At least 4 years of IT experience.
• Strong quality and compliance experience.
• Experience in evaluating IT quality and GxP issues in an FDA-regulated environment, including project team contributions and deliverables.
• Ability to evaluate IT risk issues, use data and technology for coverage, precision, and insight.
• Knowledge of IT and business controls relevant to GxP, IT quality, and 21 CFR Part 11.
• Understanding of IT risk domains such as cybersecurity, privacy, disaster recovery, change management, and operations.
• Experience with CAPA issues management in FDA-regulated settings.
• OT System commissioning and qualification experience (Radio Ligand Therapy or critical dosage forms is a plus).
• Experience with MES, QMS (Trackwise), and PAS/DCS qualification.
• Understanding of ISA95.
• OT security knowledge is a plus.
• Experience with PAS/DCS integrated with manufacturing equipment qualification.
• Strong stakeholder management and communication skills.
• Willingness to travel and work in a management consulting environment.

Preferred Qualifications:

• Knowledge of Agile/Scrum methodologies for validation.
• Experience and willingness to work in a consulting environment requiring regular travel.

Planning and coordination skills are essential.

About Us

Infosys is a global leader in digital services and consulting, operating in over 50 countries. With four decades of experience, we help clients navigate digital transformation by leveraging AI, agile digital solutions, and continuous learning to improve performance and customer satisfaction.

Infosys is an equal opportunity employer, committed to diversity and inclusion.

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Business Development

Industries

• Health and Human Services, Hospitals, and Healthcare

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