IT Director I Product Management

Pittsburgh, PA - USA

Monthly Salary: Not Disclosed

Posted on: 23 hours ago

Vacancies: 1 Vacancy

Job Summary

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client provider of digital technology and transformation information technology and services

Position: Director I - Product Management

Location: Pittsburgh PA 15222

Duration: 6 Months

Job Type: Temporary Assignment

Work Type: Remote

Job Description

Position Summary:

The Director of Lab Informatics is responsible for developing and executing a comprehensive informatics strategy to support laboratory operations across multiple functional areas including analytical development quality control (QC) and manufacturing science and technology (MSAT).
The role will drive innovation and digital transformation by integrating advanced informatics platforms that enhance data integrity increase operational efficiency and ensure regulatory compliance.
The incumbent will serve as the principal liaison between laboratory stakeholders IT QA and regulatory affairs to deliver robust scalable and compliant digital solutions.

Key Responsibilities:

Strategic Leadership & Planning

Develop and lead the execution of a multi-year lab informatics roadmap aligned with corporate digital transformation goals.
Conduct market and internal needs assessments to identify technology gaps and opportunities for automation and integration.
Provide vision and strategic direction for the adoption of cloud-based and AI-driven technologies.
Influence senior leadership decisions by providing insight into informatics trends and capabilities.

Project Oversight & System Ownership

Lead end-to-end lifecycle management of key lab systems including ELN (Electronic Lab Notebook) LIMS (Laboratory Information Management System) CDS (Chromatography Data System) and SDMS (Scientific Data Management System).
Drive cross-functional project teams through software selection system design implementation validation and deployment.
Maintain ownership of system governance change management and version control processes.
Ensure timely resolution of system issues and continuous improvement through user feedback and performance metrics.

Operations & Compliance

Ensure informatics systems are compliant with global regulatory standards (e.g. FDA 21 CFR Part 11 EU Annex 11 GAMP 5).
Collaborate with QA and Compliance teams to perform risk assessments and periodic reviews of computerized systems.
Lead preparation and support during regulatory inspections and internal audits.
Establish robust procedures for electronic data management archival and retrieval.

Team Leadership

Recruit develop and manage a multidisciplinary team of informatics professionals system administrators and project managers.
Foster a culture of collaboration accountability and innovation.
Provide coaching mentoring and performance management to support professional growth and knowledge sharing.

Cross-functional Collaboration

Act as the primary interface between scientific end-users IT infrastructure teams software vendors and senior management.
Translate complex scientific and operational requirements into technical specifications and implementation plans.
Drive user adoption and change management initiatives through effective communication and training programs.
Design and facilitate the transition plan of technology responsibilities build the accelerated adoption strategy for LIMS 12.2
Provide leadership support of the LIMS 21.3 upgrade
Provide hands on execution/leadership for the deployment of the LIMS/SAP interface
Accelerate legacy LIMS decomm strategy
Support ELN roadmap for 2026 and 2027
Help drive final decision with Empower/Chromeleon
Support solution decision and strategic plan for EM rollout (global)

Qualifications:

Bachelors degree in Life Sciences Computer Science Bioinformatics or a related field is required; advanced degree (MS PhD or MBA) preferred.
Minimum of 10 years of progressive experience in lab informatics with at least 5 years in a leadership role within a pharmaceutical biotech or CDMO environment.
Proven track record in leading successful implementations of laboratory software systems in GxP-regulated environments.

Skills & Knowledge

Deep understanding of laboratory workflows sample lifecycle management and analytical instrumentation.
Expertise in system validation data integrity principles and GxP compliance.
Strong project management skills with experience using Agile and Waterfall methodologies.
Excellent interpersonal organizational and communication skills with the ability to influence at all levels of the organization.

Preferred Qualifications:

Experience managing lab informatics systems across multiple global manufacturing or R&D sites.
Familiarity with integration of lab systems with enterprise platforms such as ERP (SAP) MES and QMS.
Understanding of emerging technologies including AI/ML NLP and data visualization tools.
Certifications in project management (e.g. PMP) or systems validation (e.g. GAMP) are a plus.

TekWissen Group is an equal opportunity employer supporting workforce diversity.

Overview: TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients world-wide. Our client provider of digital technology and transformation information technology and services Position: Director ...