GxP Qualification & Validation Lead

Sanofi Group; Framingham (MA); Vor Ort; USD 113.000 - 164.000; Vollzeit

Zusammenfassung

Sanofi Group in Framingham, MA is seeking a Qualification & Validation Specialist to lead QA oversight of validation activities across facilities, equipment, utilities, processes, and software systems. You will prepare and review qualification documents and ensure traceability and timely closure of deviations, CAPAs, and change controls.

Join a dynamic team within a global biopharma company focused on regulatory compliance (FDA/EMA), risk assessments, and continuous improvement to support

Qualifikationen

• Bachelor's degree in science, engineering, or related field with 9+ years in GxP.
• Master's degree with 6+ years in GxP.
• Experience preparing qualification documentation (protocols, reports, SOPs).
• Regulatory knowledge (FDA, EMA) related to validation.
• Ability to manage multiple validation projects.
• Experience with risk assessments and handling deviations.

Aufgaben

• Quality oversight of qualification and validation tasks.
• Prepare and review qualification/validation docs: protocols, reports, risk assessments, traceability matrices.
• Document deviations, non-conformances, and corrective actions.
• Evaluate changes controls validation.
• Ensure regulatory compliance per FDA/EMA and company standards.
• Assist audits and inspections with documentation.
• Collaborate with engineering, manufacturing, QC to execute validation activities.
• Provide expertise and support on validation; drive process improvements.

Kenntnisse

Validation documentation

Regulatory requirements (FDA/EMA)

Change controls analysis

Audits & inspections support

Cross-functional collaboration

Ausbildung

Bachelor's degree + 9+ years in GxP

Master's degree + 6+ years in GxP

Jobbeschreibung

Sanofi Group in Framingham, MA is seeking a Qualification & Validation Specialist to lead QA oversight of validation activities across facilities, equipment, utilities, processes, and software systems. You will prepare and review qualification documents and ensure traceability and timely closure of deviations, CAPAs, and change controls.

Join a dynamic team within a global biopharma company focused on regulatory compliance (FDA/EMA), risk assessments, and continuous improvement to support