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Full-Time

Manager – Quality Assurance Auditing

Confirmed live in the last 24 hours

Sarepta

Sarepta

Compensation Overview

$112k - $140kAnnually

Senior, Expert

Andover, MA, USA

Hybrid position requiring on-site work at Sarepta’s facilities in the United States.

Category
QA & Testing
Quality Assurance
Required Skills
Management
Requirements
  • Bachelor’s Degree required in a scientific discipline required.
  • Minimum 7 years’ experience in a regulated industry required; in a Quality Auditing role preferred.
  • Excellent organizational skills; ability to work independently and in team environments.
  • Must display in-depth understanding of FDA trends, FDA and EU regulations and guidelines. Must be able to demonstrate advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations.
  • Understanding of GMP/GDP compliance requirements; understanding of FDA and Global GMP Quality Requirements.
  • Must demonstrate effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities/assignments.
  • Must demonstrate effective communication skills and technical writing ability.
  • Must be able to travel domestically and/or internationally 10% of the time.
Responsibilities
  • Conduct internal audits of Sarepta GxP sites and facilities. Develop audit plans, conduct quality audits, prepare audit reports and communicate findings, including compliance risk.
  • Review and evaluate internal audit responses against current industry standards, regulations and guidelines to assure compliance. Drive closure of corrective and preventative actions to ensure implementation, compliance and continuing efficacy.
  • Lead Inspection Readiness Activities at Sarepta facilities and participate in Regulatory Inspections and Partner Audits.
  • Manage gap assessment audits and Regulatory readiness inspections at Sarepta facilities as needed.
  • Conduct external audits of Sarepta approved vendors including Contract Manufacturers, APIs, Drug Product, Primary and Secondary Packaging, Contract Laboratories, 3PL and transport vendors. Develop audit plan, conduct quality audit, prepare audit reports and communicate and escalate findings, including compliance risk. Recommends approval or disapproval of vendors based on compliance assessment.
  • Review and evaluate vendors audit response against current industry standards and guidelines to assure sufficient controls are in place by the supplier to meet quality requirements.
  • Assist in the maintenance of the annual internal and external audit schedules as requested by management.
  • Prepare metrics and reports of auditing activities and submit for Management Review.
  • Manage Sarepta’s Approved Vendor Management program as applicable to all current and new vendors. Perform vendor performance report including risk assessment.
  • Manage the Vendor Change Notification program.
  • Revise, review, and write SOPs and checklists to ensure documentation defines the steps necessary to complete required audit tasks.
  • Manage auditing files, records, reports, licenses and certificates associated with approved vendor program.
  • Maintain audit files and databases to ensure all documentation is current.
  • Assumes additional duties and responsibilities as assigned.

Company Stage

N/A

Total Funding

N/A

Headquarters

N/A

Founded

N/A