Quality Assurance Specialist, Digital Compliance
About the position
This candidate will be responsible for assisting quality and compliance efforts for implementing, validating and maintaining digital technologies in accordance with existing corporate policies, procedures and FDA, EMA, MHRA, PMDA, Health Canada and other health agency regulations to ensure compliance of these digital technologies. This candidate will also support activities to coordinate, maintain and manage digital technology suppliers and audits.
This candidate will support activities across Quality Technology & Analytics to establish a risk-proportionate, quality-driven oversight to enable data integrity and regulatory compliance.
This position is hybrid working model and will be primarily located at Cambridge, MA.
Responsibilities
• Provide quality support and compliance to implement and validate electronic systems in accordance with corporate computer system validation/computer system assurance (CSV/CSA) procedures and requirements.
• Provide QA support for IT infrastructure qualification at corporate & manufacturing facilities.
• Develop/Review validation artifacts (for example; IT system regulatory and risk assessments, 21 CFR Part 11 and Annex 11 assessments, Validation Plans, Specifications, test scripts, Installations Qualification, Operational Qualification, Performance Qualifications Protocols, Trace Matrices and Summary Reports etc.) associated with digital technologies.
• Execute/review validation protocols and associated discrepancies pertaining to digital technologies.
• Provide QA support and review system administration and maintenance procedures
• Provide QA support and review periodic review of digital technologies to ensure such technology remains in a validated state.
• Provide QA support to digital technologies changes, deviations and CAPA
• Provide QA support for continuous process improvement initiatives for CSV/CSA processes by performing/reviewing applicable gaps and remediating such identified gaps.
• Maintain the list of digital technology suppliers and coordinate, schedule and manage audits and questionnaires for such suppliers
• Perform/support internal audits for internal IT processes and external audits for digital technology suppliers
• Performs other quality and CSV/CSA related duties as necessary.
Requirements
• Bachelor’s with 3-5 years or a Master’s with 2-3 relevant experience.
• Basic understanding of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g., FDA, MHRA and EMA Data integrity guidelines etc.) around quality systems, data integrity and CSV in Biotech and/or pharmaceutical industry (GAMP5)
• Experience as a QA or Validation professional in CSV/CSA within the Biotech and Pharmaceutical industry is required.
• Experience in coordinating and managing IT Vendor Audits is required.
• Good organizational, communication, and interpersonal skills
• Effective oral and written communication skills.
• May require travel up to 15% domestically and 10% internationally
Nice-to-haves
• Experience as a lead auditor or a co-auditor for IT Suppliers is preferred
• Understanding the use of AI in GxP environment is desirable
Benefits
• We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match.
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.
Apply Now
Apply Now
This candidate will be responsible for assisting quality and compliance efforts for implementing, validating and maintaining digital technologies in accordance with existing corporate policies, procedures and FDA, EMA, MHRA, PMDA, Health Canada and other health agency regulations to ensure compliance of these digital technologies. This candidate will also support activities to coordinate, maintain and manage digital technology suppliers and audits.
This candidate will support activities across Quality Technology & Analytics to establish a risk-proportionate, quality-driven oversight to enable data integrity and regulatory compliance.
This position is hybrid working model and will be primarily located at Cambridge, MA.
Responsibilities
• Provide quality support and compliance to implement and validate electronic systems in accordance with corporate computer system validation/computer system assurance (CSV/CSA) procedures and requirements.
• Provide QA support for IT infrastructure qualification at corporate & manufacturing facilities.
• Develop/Review validation artifacts (for example; IT system regulatory and risk assessments, 21 CFR Part 11 and Annex 11 assessments, Validation Plans, Specifications, test scripts, Installations Qualification, Operational Qualification, Performance Qualifications Protocols, Trace Matrices and Summary Reports etc.) associated with digital technologies.
• Execute/review validation protocols and associated discrepancies pertaining to digital technologies.
• Provide QA support and review system administration and maintenance procedures
• Provide QA support and review periodic review of digital technologies to ensure such technology remains in a validated state.
• Provide QA support to digital technologies changes, deviations and CAPA
• Provide QA support for continuous process improvement initiatives for CSV/CSA processes by performing/reviewing applicable gaps and remediating such identified gaps.
• Maintain the list of digital technology suppliers and coordinate, schedule and manage audits and questionnaires for such suppliers
• Perform/support internal audits for internal IT processes and external audits for digital technology suppliers
• Performs other quality and CSV/CSA related duties as necessary.
Requirements
• Bachelor’s with 3-5 years or a Master’s with 2-3 relevant experience.
• Basic understanding of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g., FDA, MHRA and EMA Data integrity guidelines etc.) around quality systems, data integrity and CSV in Biotech and/or pharmaceutical industry (GAMP5)
• Experience as a QA or Validation professional in CSV/CSA within the Biotech and Pharmaceutical industry is required.
• Experience in coordinating and managing IT Vendor Audits is required.
• Good organizational, communication, and interpersonal skills
• Effective oral and written communication skills.
• May require travel up to 15% domestically and 10% internationally
Nice-to-haves
• Experience as a lead auditor or a co-auditor for IT Suppliers is preferred
• Understanding the use of AI in GxP environment is desirable
Benefits
• We offer comprehensive benefits including medical, dental, and vision coverage, life and disability insurance, a lifestyle reimbursement program, flexible spending and health savings accounts and a 401(k)with a generous company match.
• Eligible employees enjoy paid time off, wellness days, holidays, and two company-wide recharge breaks.
• We also offer generous family resources and leave.
Apply Now
Apply Now