Labcorp Early Development Laboratories Inc. has an opening for an IT Senior Manager. This is a remote position; can work anywhere in the U.S. Approximately 20-30% domestic and international travel to support client audits, site inspections and vendor assessments.
Job Description:
- Assist internal business and IT partners (manage IT involvement) in audits (client, regulatory, and internal), inspections, contract reviews, client questionnaires, required for information and proposals, and other compliance initiatives.
- Participate in global IT projects and committees serving as subject matter expert and/or provide oversight to guide business units on how to comply with statutory and regulatory requirements regarding LabCorp’s quality and compliance posture.
- Participate in the management and tracking resolution of IT audit findings and CAPA commitments.
- Participate in key IT Governance teams representing IT quality interests (i.e. system validation, infrastructure controls, risk management, policy compliance, etc.).
- Participate in the development and maintenance of formal documentation including policies, standards and procedures, consistent with corporate, legal and regulatory requirements as well as industry standard best practices.
- This position supervises 5-7 IT Client Support Specialists and 1-2 IT Managers.
Minimum Requirements:
- Must possess at least a bachelor’s degree in Life Sciences, Computer Systems, Technology or a related field and at least 10 years of progressive experience as an IT Quality Manager, IT Quality Analyst, Validation Analyst or Validation Engineer or related role working within an audit/compliance function. In the alternative, at least a master’s degree in Life Sciences, Computer Systems, Technology or a related field and at least 8 years of experience an IT Quality Manager, IT Quality Analyst, Validation Analyst or Validation Engineer or related role working within an audit/compliance function.
- Must possess at least 8 years of experience with regulatory compliance requirements in the pharmaceutical and drug development industries in USA, EU and APAC.
- Must possess at least 5 years of experience with audit processes (i.e. preparation, performance, reporting, follow-up and closure) and audit program management.
- Must possess at least 5 years of experience with direct, in-person client support requirements in the pharmaceutical and drug development industry.
- Must possess at least 3 years of experience with the application of software development principles in the pharmaceutical and drug development industry.
- Must possess at least 3 years of experience with information systems infrastructure support in a pharmaceutical and drug development industry.
- Must possess at least 3 years of experience with the application of information security and of IT risk management principles in a pharmaceutical and drug development industry.
Approximately 40 hours per week; salary range is $176,904 to $200,000 per year.
Application Window Closes: 11-14-25
All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Casual, PRN & Part Time employees regularly scheduled to work less than 20 hours are eligible to participate in the 401(k) Plan only. For more detailed information, please click here.
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law.
We encourage all to apply
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