Digital QA Manager
for each heading. Use - for lists. Use
for prose.
We need to preserve all substantive information, not invent. Remove boilerplate like purpose statements? The purpose paragraph is maybe not needed? It's part of description but could be considered "About the role"? Actually "WHAT WE ARE LOOKING FOR" is a heading. The text before that is company overview. Might be considered "About the role"? The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to those headings. Likely "About the role" corresponds to the description of what the role does (the WHAT WE ARE LOOKING FOR paragraph). Then "Responsibilities" corresponds to "YOUR ROLE" bullet list. Then "Requirements" maybe corresponds to "YOUR BACKGROUND Required Qualifications". Then "Qualifications" maybe corresponds to "Preferred Qualifications". Skills maybe not explicit; could combine with qualifications? But we should only include sections with real specific content. There's no explicit Skills section separate; we could omit Skills. Benefits, Pay, Schedule omitted.
We need to preserve all substantive information: include company purpose? Might be considered part of "About the role"? Probably not needed; but we could include a short paragraph under About the role summarizing the role purpose. The instruction: Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. So we can include a brief paragraph about the company under About the role? Might be considered filler but it's substantive info about the company. However the instruction says "Prefer a few substantive sections over many thin ones." Could include About the role with a paragraph summarizing the role and maybe company context.
Let's extract:
Company purpose: "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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging."
That's company overview; could be placed under About the role.
Then "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."
That's more about role responsibilities; could be part of About the role or Responsibilities. We'll split: About the role: company overview + brief role purpose. Responsibilities: the detailed list under "YOUR ROLE". Then Requirements: Required Qualifications. Qualifications: Preferred Qualifications.
We need to format lists: Under YOUR ROLE there are many sentences each starting with a verb. We can turn each into
- . Also there is "Additional Manufacturing Quality Assurance Shift Lead Responsibilities" which seems like extra responsibilities; we can include those as part of Responsibilities as well.
Let's parse YOUR ROLE sentences:
- 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
Then "Additional Manufacturing Quality Assurance Shift Lead Responsibilities" list:
- 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.
We'll combine all into one responsibilities list.
Now 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
We'll output HTML:
About the role
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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. 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.
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
for prose. We need to preserve all substantive information, not invent. Remove boilerplate like purpose statements? The purpose paragraph is maybe not needed? It's part of description but could be considered "About the role"? Actually "WHAT WE ARE LOOKING FOR" is a heading. The text before that is company overview. Might be considered "About the role"? The instruction: Use
for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we need to map content to those headings. Likely "About the role" corresponds to the description of what the role does (the WHAT WE ARE LOOKING FOR paragraph). Then "Responsibilities" corresponds to "YOUR ROLE" bullet list. Then "Requirements" maybe corresponds to "YOUR BACKGROUND Required Qualifications". Then "Qualifications" maybe corresponds to "Preferred Qualifications". Skills maybe not explicit; could combine with qualifications? But we should only include sections with real specific content. There's no explicit Skills section separate; we could omit Skills. Benefits, Pay, Schedule omitted. We need to preserve all substantive information: include company purpose? Might be considered part of "About the role"? Probably not needed; but we could include a short paragraph under About the role summarizing the role purpose. The instruction: Do NOT repeat the job title as a heading (the page already shows it) and do NOT put Job ID / requisition numbers as headings — fold minor metadata into a short
or drop it. So we can include a brief paragraph about the company under About the role? Might be considered filler but it's substantive info about the company. However the instruction says "Prefer a few substantive sections over many thin ones." Could include About the role with a paragraph summarizing the role and maybe company context. Let's extract: Company purpose: "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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging." That's company overview; could be placed under About the role. Then "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." That's more about role responsibilities; could be part of About the role or Responsibilities. We'll split: About the role: company overview + brief role purpose. Responsibilities: the detailed list under "YOUR ROLE". Then Requirements: Required Qualifications. Qualifications: Preferred Qualifications. We need to format lists: Under YOUR ROLE there are many sentences each starting with a verb. We can turn each into
About the role
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 100 years, we continuously innovate to improve the diagnosis, prognosis and quality of life of patients. Customer Centricity, Cooperation, Audacity, Focus, and Responsibility are the values that we share and practice on a daily basis. Working at Guerbet is not only being part of a multicultural team with nearly 3,000 people across more than 20 countries, but it is above all about playing a unique role in the future of medical imaging. 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.
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