INACTIVE
Full-Time
Manager – Quality Compliance
Posted on 4/11/2024
Develops CRISPR-based gene editing medicines
Biotechnology
Mid, Senior, Expert
Cambridge, MA, USA
Required Skills
Management
Requirements
- 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
- Outstanding organizational skills and attention to detail
- Ability to communicate effectively
- Ability to travel approximately 20% per year, domestically and internationally
Responsibilities
- 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
Editas Medicine specializes in CRISPR gene editing technologies, including CRISPR/Cas9 and CRISPR/Cas12a, to create groundbreaking treatments for serious diseases. This company offers a technologically advanced environment where employees can contribute to pioneering efforts in medical science. Working here provides a unique opportunity to engage in impactful research and development that could potentially improve the lives of people worldwide.
Company Stage
IPO
Total Funding
$884.6M
Headquarters
Cambridge, Massachusetts
Founded
2013
Growth & Insights
Headcount
6 month growth
↑ 11%1 year growth
↑ 24%2 year growth
↑ 14%INACTIVE