Manager, Quality Compliance
Editas Medicine
- Cambridge, MA
- Permanent
- Full-time
- Conduct and manage the internal audit program, scheduling, performance, follow up and closure.
- Manage the external audit program, working closely with supplier quality.
- Prepare audit reports and maintain audit files.
- Review and approval of all audit reports and responses.
- Work with departments/auditees to address identified issues, provide recommendations, and facilitate the corrective action process.
- Communicate action items and escalate issues to management.
- Ensure audit findings are addressed in a timely manner.
- Assist with trend analyses related to audits (e.g. types/number of observations).
- Research applicable regulations and standards to ensure the Company's ongoing compliance.
- Assist in maintenance of the annual internal and external audit schedules as requested by management.
- Revise, review, and write SOPs, checklists, and quality documents.
- Participate in Quality Risk Management exercises
- Lead and support the preparation activities for GxP Compliance audits and Health Authority Inspections as needed.
- Work with leadership and partner with colleagues to develop and maintain a robust strategy, including action plans and tracking to ensure Editas is inspection ready at all times.
- Support GxP Inspection Readiness assessments/plans
- Promote a culture of quality and operational excellence. Proactively identify areas for improvement and work across multiple organizations to influence and implement solutions.
- Align expectations across Editas as it pertains to Inspection Readiness activities and oversight.
- Identify Quality risks and track, report on and facilitate mitigation of identified risks as it pertains to Inspection Readiness.
- Drive effective management of quality issues and make decisions that may involve complex quality and technical issues.
- Contribute to Quality by undertaking a variety of roles and assignments to further develop internal processes and people.
- Ability to travel domestically and internationally
- Other duties or special projects as assigned.
- Bachelor's degree
- 7+ years experience in Quality Assurance in the pharmaceutical, biopharma industry
- 3+ years experience conducting audits as the lead auditor
- Extensive knowledge of Good Manufacturing Practices (GMPs), US FDA and EU GMP regulations and ICH guidelines.
- Background in hosting and/or supporting US health authority inspections.
- Ability to work on a team and independently on projects
- Demonstrated ability to perform internal and external audits
- Outstanding organizational skills and attention to detail
- Ability to communicate effectively
- Ability to travel approximately 20% per year, domestically and internationally
- Certification as a quality auditor from ASQ, RAPS, ISO or equivalent.
- Cell and Gene Therapy experience
- Demonstrated experience using Quality Risk Management tools.