IT Audit And Compliance Manager - Information Technology Management

About the Company:

At LabConnect, we’re helping accelerate the future of medicine. As a leading global central laboratory partner, we work at the center of clinical research, powering trials with smart, scalable, technology-enabled solutions that help biotech, pharmaceutical, and clinical research organizations bring breakthrough therapies to patients faster.

With more than 20 years of experience, 2,000+ clinical studies supported, and operations spanning 93 countries, LabConnect offers the scale of a global organization with the energy and momentum of a company that continues to grow and evolve. Our teams across North America, Europe, Australia, and China are united by a shared commitment to innovation, collaboration, and making a real impact in healthcare worldwide.

LabConnect is seeking a Manager, IT Quality & Compliance to strengthen the partnership between technology and Quality, and to help that partnership become faster, clearer, and more effective. This role runs the day-to-day quality workflow for technology: quality events, deviations, CAPAs, the IT SOP lifecycle, training impact, change control evidence, and periodic system reviews. That is the floor of the job, not the ceiling. We are looking for someone who can distinguish between regulatory requirements and process inefficiencies, redesign workflows to improve both compliance outcomes and the employee experience, and build practical alignment across Technology, Quality, and GRC. This role is best suited for someone who enjoys improving processes, simplifying complexity, and driving meaningful change in a collaborative, regulated environment. If your instinct is to understand the true regulatory requirement, design a better solution, and bring stakeholders together around an approach that strengthens both compliance and operational effectiveness, this may be the role for you.

You will report to the Director/Sr. Director of Governance, Risk, and Compliance and partner closely with the Quality organization that owns CSV and GxP validation. You will work every day alongside software engineers, data engineers, infrastructure, and product teams, and you will be expected to be in the room where the work happens rather than at the end of it.

Position Overview:

In this role you will run the technology side of LabConnect’s quality management system while actively improving it. You will triage and shepherd quality events and deviations raised against technology systems, drive CAPAs to genuine closure rather than paper closure, own the IT SOP register and its change history, coordinate training impact, and prepare and lead periodic system reviews and audit walkthroughs. In parallel, you will look for places where the process itself can work better: forms that collect information nobody reads, approval chains that add delay without adding assurance, and evidence that engineers already generate in their tooling but are asked to recreate by hand in a document. You will propose improved approaches, partner with Quality to assess risk and compliance implications, pilot solutions, and drive adoption across the organization.

LabConnect is building an AI-enabled control environment in which controls are authored, tested, and enforced continuously rather than rediscovered during an audit. You are the person who helps make that real at the level of daily practice. Success looks like shorter change cycles, fewer repeat findings, deviations that get to true root cause instead of “human error,” and automated evidence that Quality, Technology, and auditors can rely on with confidence.

Key Areas of Responsibilities

• Quality Event, Deviation, and CAPA Ownership: You will be the single front door between technology and the Quality organization for quality events and deviations involving software, data, and infrastructure. You will run intake and triage, drive investigation with the engineering teams involved, push investigations past the first plausible answer to actual root cause, write or co-write the record, and carry CAPAs through to effectiveness verification. You will track recurrence and treat a repeat finding as a signal to strengthen the corrective action and supporting process.
• Workflow Redesign Between Engineering and Quality: You will map how work actually moves between technology and Quality today, measure where time and rework accumulate, and redesign the handoffs. This means separating what regulation genuinely requires from what is habit, local interpretation, or a control that outlived its risk. You will work with Quality to evaluate proposed improvements, develop the supporting risk and regulatory rationale, pilot solutions, and drive adoption through updated procedures and training.
• IT SOP and Controlled Document Lifecycle: You will own the IT SOP register: what exists, who owns it, when it was last reviewed, what changed, and who needs to be trained. You will drive periodic review on a real cadence instead of a scramble, retire procedures that no longer reflect practice, and write in plain language that an engineer will read and follow. You will use AI-assisted drafting and gap analysis where it earns its place, with a review and approval model you can defend to an auditor. You will be the technical owner of how technology’s content and workflows are configured in Veeva Vault, including lifecycles, permissions, reporting, and the integrations that feed it.
• Periodic Review and Audit Readiness: You will plan and run periodic system reviews across the GxP application and infrastructure landscape, coordinate technology’s participation in sponsor audits, client qualifications, and regulatory inspections, and prepare the people who will be in the room. Over time you will shift the organization from audit preparation projects to evidence that is continuously available.
• Engineering-Native Controls and Evidence Automation: You will work with engineering to move control evidence to where the work already happens: change control tied to pull requests and tickets, traceability from requirement to code to test result, access reviews pulled from the identity platform, and audit trail and record retention verified by automated check rather than by screenshot. You will then partner with Quality to demonstrate that automated evidence meets validation and regulatory expectations and can be confidently incorporated into the control environment.
• Change Control and Validation Partnership: You will make sure technology changes move through change control quickly and correctly, that validation effort is scaled to actual risk in line with computer software assurance thinking, and that the boundary between low-risk changes and changes requiring formal validation is written down, understood by engineers, and applied consistently.
• Training, Enablement, and Adoption: You will build the enablement that makes compliant behavior the path of least resistance: short, practical guidance at the point of work, onboarding that gets new engineers productive inside the QMS quickly, and training records that hold up. You will treat low adoption of a procedure as a signal that the procedure needs rework, not that the team needs another reminder.
• Metrics and Transparency: You will publish the numbers that show whether this is working: cycle time on quality events and CAPAs, overdue and at-risk items, SOP review currency, training completion, repeat finding rate, and audit outcomes. You will use those metrics to guide improvement, build shared understanding, and adjust course when an initiative is not delivering the intended result.

Core Competencies & Skills

• Change Agency in a Regulated Setting: You have improved a quality or compliance process rather than only operated one, and you can describe what you changed, how you got it approved, and what it cost you to get there. You are comfortable asking why a control exists, partnering with stakeholders to test better approaches, and respecting the answer when the control is clearly tied to risk or regulation.
• Veeva Vault Technical Ownership: You have configured and administered Veeva Vault yourself, not only used it. That means object and document type models, lifecycles and workflows, security and permission sets, picklists and reference data, Vault Loader, reports and dashboards, sandbox and release management, and the Vault API or integrations into surrounding systems. You understand how Vault configuration changes are themselves validated and controlled, and you can tell the difference between a problem that needs a configuration change and one that needs a process change.
• Quality Systems Fluency: You have worked hands-on across deviations, CAPAs, change control, document control, and training inside an electronic QMS. Exposure to TrackWise, MasterControl, or Qualio alongside Veeva is useful. You know what good investigation writing looks like and can produce it yourself.
• GxP and Part 11 Command: You have a practical command of GCP or GLP environments, FDA 21 CFR Part 11 and EU Annex 11, computer system validation, and risk-based computer software assurance, including how validation expectations apply when software is written or reviewed with AI assistance.
• Engineering Literacy: You are credible with software engineers. You understand source control, branching and pull requests, CI/CD pipelines, infrastructure-as-code, ticketing systems such as Jira or Azure DevOps, and cloud platforms well enough to know where control evidence already lives and to design controls engineers can actually follow.
• AI-Assisted Compliance Curiosity: You are interested in using AI on compliance work itself, for drafting and maintaining controlled documents, gap analysis across procedures and systems, and investigation support, along with the judgment to know which outputs need human review before they carry regulatory weight.
• Influence Without Authority: Most of what you need will be delivered by people who do not report to you. You build credibility with engineers by creating practical, scalable processes and with Quality by ensuring those processes meet regulatory expectations and withstand audit scrutiny. You can hold a clear position while maintaining trust across teams.
• Clear Writing: You write procedures, investigations, and assessments that are short, unambiguous, and readable by their audience. You treat unnecessary length as a defect.

Qualifications & Experience

• Bachelor’s degree in life sciences, engineering, information systems, computer science, or a related field is required.
• 7+ years in quality, compliance, validation, or regulated IT, including at least 3 years in a GxP environment such as clinical research, central laboratory, pharmaceutical, biotechnology, or medical device.
• Practical working knowledge of FDA 21 CFR Part 11, computer system validation, and risk-based computer software assurance.
• Required: demonstrable hands-on technical experience configuring and administering Veeva Vault, including lifecycles and workflows, object and document type configuration, security and permissions, reporting, sandbox and release management, and integrations or the Vault API. Candidates who have only been end users of Vault are not a fit for this role.

Preferred Experience

• Demonstrated hands-on ownership of deviations, CAPAs, change control, and controlled document lifecycle in an electronic quality management system.
• Direct experience supporting or leading sponsor audits, client qualification visits, or regulatory inspections, with responsibility for the evidence presented.
• Experience working day to day with software engineering teams and their tooling, including source control, CI/CD, and ticket-based change management.
• Experience in a central laboratory, CRO, or clinical trial operations environment is preferred. CLIA and CAP familiarity is a plus.

Differentiators

• Experience applying AI or intelligent automation to documentation, investigation, or control monitoring is strongly preferred.
• Evidence of having changed how compliance work gets done, not only having performed it, and of carrying that change through to adoption.
• Professional certification such as ASQ CQA, ASQ CMQ/OE, RAC, or equivalent is a plus.

Compensation & Benefits

• Competitive base salary aligned to experience
• Annual incentive opportunity through the company’s bonus plan
• Comprehensive benefits package

Join our team and discover how your work can impact patients' lives around the world!

Some of the Perks our LabConnectors Love:

• Financial Security (Base Pay, 401k Match and Possible Annual Bonus Eligibility)
• Health Benefits beginning on date of hire
• PTO plan, plus 11 Paid Company Holidays, and 1 Day to Volunteer in your community
• Short and Long-Term Disability, Life Insurance, and AD&D
• We celebrate our differences, which enriches our culture!

In addition to great perks and challenging work assignments, we invest in our people with career growth opportunities, globally. We believe in a friendly and collaborative environment with open lines of communication. While living out our values of People First, Quality Focused, Customer Centered, Technology Driven, and Accountability Always.

We are proud to be an Equal Employment Opportunity Employer and value the diversity of our workforce. We do not discriminate on the basis of race, gender, age, disability, religion, sexual orientation, or any other protected characteristic. To learn more about equal employment opportunity, please view the posters here: https://www.dol.gov/agencies/whd/posters

LabConnect also prioritizes the privacy and security of your personal data. All candidate information is handled in accordance with General Data Protection Regulation (GDPR). To learn more, please review our Privacy Notice on our website, by navigating to https://www.labconnect.com/

If you need assistance to complete your job application, search for a job opening, or submit an online application at LabConnect, please email talent@labconnect.com or call +1 (423) 722-3155.