Digital QA Manager (Raleigh, US)

Guerbet; Raleigh (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Guerbet, a global leader in medical imaging, seeks a Digital QA Manager to oversee computerized systems in GMP manufacturing and labs, ensuring data integrity, validation, and regulatory alignment.

You will drive the digital quality roadmap, collaborate with IT, Manufacturing, and Quality, and lead cross-functional teams to strengthen compliance and efficiency across the site.

Qualifications

• 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.

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.
• 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
• Lead and mentor QA staff supporting digital and computerized systems.
• Represent Quality during internal audits, regulatory inspections, and vendor audits related to computerized systems.

Skills

Quality governance

Data Integrity

GMP/regulatory knowledge

Cross-functional leadership

Education

Bachelor’s degree in Life Sciences or Engineering

Advanced degree (preferred)

Tools

eQMS

LIMS

CSV/CSA

Job description

Digital QA Manager

At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.

We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.

Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.

Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.

For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube

WHAT WE ARE LOOKING FOR

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.

YOUR ROLE

• 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

Additional Manufacturing Quality Assurance Shift Lead Responsibilities

• 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.

YOUR BACKGROUND

Required Qualifications

• 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

Preferred Qualifications

• 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

Reason to join US

Much more than a Competitive salary,

We offer continued personal development. When you join Guerbet, you :

• Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
• Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world,
• Are joining a company where we value diversity of talents coming from various horizon.

We # Innovate # Cooperate # Care #Achieve at Guerbet.

Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to [e-mail] or you can also call this number [phone]