Sr. QA Manager, Supplier Quality
About The Position
RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organization creating cutting-edge therapies that change people’s lives. Collaborative, dedicated, and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilizing ground-breaking science. Here at RoslinCT, our team can contribute to the development of revolutionary treatments. We live every day by our core values: Partner Focus, One Team, Personal Growth, Integrity, Innovation, and Trust and Respect. We put our employees at the forefront by providing a flexible and empowering work environment, an attractive benefits package, and an emphasis on work-life balance. Our people are the key to our success. At RoslinCT we focus on developing our corporate culture, people’s development, growth, and the ability to impact patients. The Senior QA Manager, Supplier Quality is responsible to support the development, implementation, and on-going management of Supplier Quality Programs. The ideal candidate is a self-starter with experience in a startup environment.
Requirements
- A highly organized work style that ensures timely execution of tasks.
- A mindset that ensures accurate results.
- Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
- Effective problem-solving capabilities.
- Strong oral and written communication skills.
- 8+ years relevant Supplier Quality experience in a pharma/biotech company, working within a Quality System and regulated GMP environment. Cell therapy experience a plus
- Prior experience with implementing quality systems and/or continuous improvement initiatives focused on Quality Systems and Supplier Quality
- Must be team oriented; previous management experience preferred
- Ability to partner cross functionally and integrate feedback during development and implementation of quality systems
- Ability to work independently to meet objectives and timelines
- Ability to make decisions of moderate/high complexity independently and escalate complex decisions as needed.
- Well versed in cGMP and ICH regulations/ guidelines
- Domestic and International travel will be required
- Must be able to perform in person and/or virtual audits
Nice To Haves
- Quality Audit certifications a plus
- Cell therapy experience a plus
Responsibilities
- Manage and further develop the Supplier Quality Program
- Manage and conduct Supplier Audits
- Manage the Supplier Qualification activities including classification evaluation, quality agreements and quality questionnaires; further development with peers
- Manage Supplier Change Notification (SCN) Program
- Manager Supplier Corrective Action Requests and Notifications (Support creation and management of supplier investigations)
- Develop programs, workflows and standard operating procedures for the Supplier Quality program.
- Monitor implementation of Supplier Quality programs, ensuring compliance to SOPs and identifying areas for improvement
- Support implementation and training of associated systems
- Act as Supplier Quality SME for NCMRs (Non-conforming Material Requests)
- Assist Quality Systems during health authority inspections and client audits
- Review/Approve Deviations, Change Controls and CAPAs as necessary
- Contribute to development of Key Performance Indicators that measure effectiveness of QMS and assist with tracking and trending of Supplier Quality data
- Support reporting of KPls as part of Quality Management Review
- Mentor personnel within QA and cross functionally on Supplier Quality Systems to promote a quality culture
- Other duties as assigned.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
Number of Employees
251-500 employees
