- 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.
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Manager, Quality Compliance - Cambridge, United States - Editas Medicine
Description
At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing.
We believe our people are at the core of everything we do, and we're committed to cultivating a culture where every individual feels valued and included. To do this, we strive to integrate belonging, inclusivity, diversity, and equity into every aspect of our organization.
Together, we are leading the way towards a healthier and more equitable future
The Manager, Quality Compliance, is responsible for Audit Management and Inspection Readiness. The incumbent is responsible for the planning, management and execution of Internal Audit activities and External Audit activities in accordance with company procedures. This position will interface with individuals at all levels of the organization and external partners to manage and conduct audits at specified intervals and report audit findings. This position will facilitate and monitor the life cycle of audit findings until completion.
The Manager, Quality Compliance will support the inspection readiness program and support the plan, structure, implementation, education, awareness and reporting for the program.
Description:
Requirements:
Benefits Summary:
Editas provides a comprehensive array of benefits to all employees, including a Blue Cross Blue Shield PPO Medical Plan, a company-funded Health Savings Account, Dental and Vision Insurance, Life and Disability Insurance, Dependent Care Account, Tuition Reimbursement, 401(k) plan with company match, Employee Stock Purchase Plan, Employee Assistance Plan, Wellness Programs, and a flexible Paid Time Off policy.
If you are a results-focused and collaborative professional with a passion for advancing transformative therapies, we invite you to apply. Join us at the forefront of genetic innovation and be a key contributor to Editas Medicine's mission of redefining healthcare through cutting-edge genetic technologies.
Fostering Belonging. Fueling Innovation. Transforming Lives.
