Associate Director, QA Compliance
At 2seventy, it's all about time – how you use your time to do meaningful work that matters, who you choose to spend your time with, and how we can give more time to our patients. When you join us, you are so much more than a number – we invite you to bring all of you and become part of a community where we believe we are better 2gether. Are you ready to re-think the (im)possible? Not only are we ready – we are doing it. The time is NOW.
The Quality Systems team provides quality and compliance oversight and support for GxP Quality Management Systems elements. In this role, you will support the organization by providing GMP/GLP QA oversight for activities required at all stages of 2seventy bio products' life cycle. This position is actively involved in executing the QA strategy by contributing to risk-based assessments, providing QA leadership to foster cross-functional partnerships, and implementing regulatory intelligence processes. Oversees and is directly responsible for inspection readiness efforts and the internal audit program to meet all US, European and global Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) requirements. The Associate Director of Compliance will also partner with Development Quality and Supply Chain Quality on the external audit program and inspection readiness.
ABOUT THE ROLE:
- Provides leadership for inspection management
- Ensure audit readiness for GMP/GLP compliance to regulatory and client inspections
- Constantly promote QA Compliance within the development community and actively seek out additional tasks that would benefit from QA Compliance input
- Apply Continuous Improvement methodologies to compliance processes, tooling and workflows
- Establish internal audit plans and execute such plans and follow-ups meeting internal regulatory requirements to ensure compliance to quality systems on site
- Perform internal audits for the maintenance and continuous improvement of the management system and compliance to regulatory requirements
- Conduct internal auditor training
- Promptly escalate all compliance issues to Quality and Senior Management
- Ensures that the status of the QMS is communicated to appropriate stakeholders including management, and that any required actions are identified and executed to ensure the continuing suitability and effectiveness of the QMS
- Ensures that quality risks are communicated to appropriate stakeholders including management, and that any required actions are identified and executed to ensure proper risk management
ABOUT YOU:
- Bachelor's degree in a scientific discipline with 10+ years of training experience in a GxP regulated industry.
- Expert knowledge of GxP regulations, quality systems, and guidance documents (including ICH)
- Experience with leading internal/external audits, participation in regulatory inspections
- Strong technical knowledge including but not limited to: Quality Control, auditing techniques, and QMS design
- Teaching and facilitation skills
- Solid quality culture knowledge and understanding of how to influence and improve overall compliance
- Experience with impact and risk assessment tools, process mapping and process improvement tools
- You should enjoy pushing limits, creating solutions, and working within a highly motivated culture where our mission – to offer patients and their families more time – is at the heart of all we do.
- Motivated to solving difficult, messy problems like developing cell therapies for cancer—it's hard!
- Ability to communicate above and below level in a way that fosters relationship building, including cross-functional teams, and external relationships with vendors
- Successfully worked in a collaborative team environment where results are achieved through influence and incorporating multiple points of view
- Must have excellent attention to detail, project and time management skills, and the ability to manage multiple priorities
- Embraces and models our core values—re: think, have: heart, better: 2gether, time: is now
- Ability to travel up to 15%