Sr. Manager, Quality Systems & Continuous Improvement

Sr. Manager, Quality Systems & Continuous Improvement page is loaded## Sr. Manager, Quality Systems & Continuous Improvement locations:
type:
Full time posted on:
Posted Todayjob requisition :
JR100092
** COMPANY:
*** At Bio Cryst, we share a deep commitment to improving the lives of people living with complement-mediated and other rare diseases. For over three decades we’ve been guided by our passion for not settling for “ordinary” in our quest to develop novel medicines. We leverage our expertise in structure-guided drug design to develop first-in-class or best-in-class oral small-molecule and protein therapeutics, led by the efforts of our team of expert scientists in our Discovery Center of Excellence in Birmingham, Alabama.

Our global headquarters is in Durham, North Carolina and our employees span the globe across sites in multiple countries. We are proud of our culture of engagement and accountability that rewards people for innovative thinking and achievement of key objectives. For more information, please visit our website at
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* JOB SUMMARY:

**### The Senior Manager, Quality Systems and Continuous Improvement (CI), will drive CI initiatives within the Bio Cryst Quality Management System (QMS) while partnering cross functionally with all GxP QA to ensure robust, efficient processes are implemented and maintained.  He/she will also lead the implementation of medical device regulatory requirements within Bio Cryst’s existing QMS while ensuring processes are adapted and compliant with global medical device standards and aligned with pharmaceutical GxPs.

Other responsibilities will include procedure development, risk-based compliance strategies, and inspection readiness for combination products and medical devices.### ### This position will act as the backup and co-administrator for global management/administration of multiple electronic systems which include:
Documentation Management System (DMS), QMS, and Learning Management System (LMS). Additionally, he/she will own Internal Audit Program Management ensuring proactive compliance monitoring and inspection readiness while partnering with the Quality Leadership Team to ensure a fit for purpose program is implemented and maintained. This position will also be responsible for supporting the overall quality strategy and risk mitigation including support of internal and external audits and inspections.
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* ESSENTIAL DUTIES & RESPONSIBILITIES:

*** Leads the identification and execution of quality and process improvements of Quality GxP process, driving continuous improvement initiatives using risk-based methodologies to enhance efficiency and compliance, in close collaboration with QA leadership and cross-functional teams.
* Lead the implementation and maintenance of combination products and medical device regulatory requirements (ISO 13485, 21 CFR 820, EU MDR) within Bio Cryst’s existing Quality Management System (QMS).
* Translate ISO 13485, 21 CFR 820, and EU MDR requirements into practical QMS processes by developing and updating SOPs and work instructions to meet device-specific compliance needs.
* Manages and leads the Internal Audit Program across all GxPs ensuring a robust, risk-based framework aligned with global regulatory expectations. Partners with QA leadership to design, execute, and monitor the audit schedule, ensuring timely completion and proactive compliance.
* Responsible for the scheduling of the QMR, Quality Council and Quality council meetings, ensuring attendee lists are maintained, meetings are documented and slide decks are prepared and shared in advance where appropriate.
* Responsible for coordinating Quality Management Review (QMR), Quality Council, and related meetings, ensuring attendee lists are current, meetings are properly documented with minutes, and presentation materials are prepared and distributed in advance as appropriate.
* Designated back up for QA oversight of GxP Computer Systems Validation ensuring GxP IT systems are validated and maintained in accordance with regulatory requirements
* QMS & Training support responsibilities include:  + Act as the system administrator for the DMS and…