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JOB TITLE:Quality Manager III (Engineering)

LOCATION: REMOTE

DURATION: 12+ MONTHS

CLIENT: SANOFI



10-12 years of experience (Experience at Consultant or Director Level preferred) • Pharmaceutical or Medical Device regulations experience

SanofiRemote for Superstar!





The position can be offered as fully remote for a highly qualified candidate Possibility of an extension Free parking available onsite Must-Have Skills: • 10-12 years of experience (Experience at Consultant or Director Level preferred) • Pharmaceutical or Medical Device regulations experience • Pharmaceutical Manufacturing Experience • Writing, reviewing and negotiation of Quality Agreements with Vendors • Strong Vendor Management experience (role will serve as the liaison between vendors and internal stakeholders) • Previous experience overseeing internal audits and reporting metrics • GXP documentation Nice to Have: • 15+ Years of Experience



Description:



Principal Duties:
• Lead the management and improvement of Sanofi’s mRNA CoE Inspection Readiness Program.
Maintain current Internal/External audit calendars and prepares and organizes audit management activities.
• Plan audit calendars, develop audit schedules and maintain audit logs.
Communicate with external vendors, schedule creation and ensure timely project deliverables.
Scheduling, planning, execution and documentation of internal audits of Sanofi’s mRNA CoE QMS.
Ensures all audit findings are closed in a timely manner with effective corrective action, by assisting owners on investigations and action plans.
• Lead resource on inspection preparation, resolution management of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audit.
• Leads the execution of the remediation responses to ensure progress by working with key stakeholders in their timely completion of identified deliverables.
• Lead the organization and maintenance of the Vendor Management Program, which includes the vendor approval and qualification process as well as maintenance of the Approved Vendor List.
• Ensures new vendor request forms are created and vendor evaluations are completed.
Lead resource in communication with external vendors for creation and response to vendor questionnaires.
• Write, review and negotiate Quality Agreements with Vendors.
• Minimum Education: Bachelor's Degree/Undergraduate Degree in engineering or technical discipline.
Reference : Quality Manager jobs

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Published at 03-04-2023
Viewed: 80 times