Digital QA Manager

Laboratoire Guerbet•Raleigh, IL

48d

About The Position

The Digital Quality Assurance Manager will operate in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization’s framework, company’s procedures, and the defined scope of responsibility the role is accountable for. The Digital Quality Assurance Manager is responsible for providing quality oversight, governance, and strategic direction for digital quality systems within a GMP-regulated manufacturing environment. This role ensures the integrity, compliance, and lifecycle management of computerized systems supporting manufacturing, laboratory, and quality operations, while actively driving digital transformation and continuous improvement initiatives. The position serves as a key interface between Quality, IT, Manufacturing, and Laboratory functions, ensuring that digital solutions meet regulatory expectations for data integrity, validation, security, and system performance. The Digital QA Manager also leads the development and execution of the site’s digital quality roadmap to improve compliance, efficiency, and inspection readiness.

Requirements

Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline
8+ years of experience in pharmaceutical manufacturing or quality assurance, with significant focus on computerized systems and digital quality
Strong working knowledge of CSV/CSA, Data Integrity, eQMS, and LIMS in regulated environments
Demonstrated experience leading digital transformation or process improvement initiatives
Strong understanding of global regulatory requirements and inspection expectations
Proven ability to lead cross-functional teams and manage complex projects

Nice To Haves

Advanced degree in Life Sciences, Engineering, or a related technical discipline
Certification in CSV, CSA, or Quality Systems (e.g., ASQ, Six Sigma)
Experience implementing or optimizing digital quality systems such as eQMS or LIMS
Experience supporting regulatory inspections related to computerized systems and data integrity
Familiarity with risk-based validation approaches and lifecycle management of computerized systems

Responsibilities

Provide Quality oversight for computerized systems used in GMP manufacturing and laboratory operations, ensuring compliance with 21 CFR Parts 11, 210, 211, Annex 11, and applicable global regulations.
Establish and maintain Data Integrity governance, ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, Available).
Lead investigations and risk assessments related to data integrity issues, audit findings, and regulatory observations involving digital systems.
Define and approve controls for user access, audit trails, electronic records, and electronic signatures.
Provide strategic and operational oversight of electronic QMS platforms (eQMS), including exceptions, CAPA, Change Management, Complaints, Training and Document Management
Ensure configuration, workflows, and system changes are appropriately risk-assessed, validated, documented, and approved.
Act as system owner or quality system sponsor for digital QMS applications, including lifecycle management and vendor oversight at site level.
Provide QA oversight for LIMS and other computerized laboratory systems (e.g. Empower).
Ensure laboratory data integrity, sample traceability, result accuracy, and audit trail review processes are established and maintained
Participate in system validation, enhancements, periodic reviews, and system decommissioning activities.
Support laboratory inspections and audits related to computerized systems and electronic data.
Ensure systems follow a compliant CSV / CSA (Computer Software Assurance) approach based on system risk and intended use.
Review and approve validation deliverables, including URS, risk assessments, test strategies, and validation summary reports.
Oversee periodic reviews to confirm systems remain in a validated state.
Lead the development and execution of the site digital quality roadmap, aligned with business strategy, regulatory expectations, and corporate standards.
Identify and prioritize opportunities for digitalization, automation, and system integration to improve quality processes and data visibility.
Apply risk-based and Lean principles to simplify workflows, reduce cycle times, and improve compliance efficiency.
Performs other duties as assigned by management
Serve as a trusted Quality partner to IT, Manufacturing, MSAT, and Laboratory groups on digital initiatives.
Lead and mentor QA staff supporting digital and computerized systems.
Represent Quality during internal audits, regulatory inspections, and vendor audits related to computerized systems.
Collaborate with global and corporate Quality organizations to align standards and best practices.
Ensures timely issue escalation to Quality management and Operations leadership when quality standards, process controls, or aseptic practices are at risk.
Supports reinforcement of quality culture by ensuring consistent application of GMPs, compliance for computerized systems, and procedural adherence.