Sr. Manager, Quality Systems & Continuous Improvement

Role Summary

The Senior Manager, Quality Systems and Continuous Improvement (CI) will drive CI initiatives within the BioCryst Quality Management System (QMS) while partnering cross-functionally with all GxP QA to ensure robust, efficient processes are implemented and maintained. They will lead the implementation of medical device regulatory requirements within BioCryst’s QMS, ensuring processes are adapted and compliant with global medical device standards and aligned with pharmaceutical GxPs. Other responsibilities include procedure development, risk-based compliance strategies, and inspection readiness for combination products and medical devices. This role also acts as backup and co-administrator for the management of multiple electronic systems (DMS, QMS, LMS), owns Internal Audit Program Management, and supports overall quality strategy and risk mitigation including audits and inspections.

Responsibilities

• Leads the identification and execution of quality and process improvements of Quality GxP processes, 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 BioCryst’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 carry out processes utilized for the creation, editing, review and approval of controlled documentation (e.g., SOPs, Policies) and other documentation that utilizes the functions/features of the DMS to manage and hold documentation.
  • Develop and maintain training documentation, including system vendor video training, slide decks and SOPs and work instructions specific to the DMS and QMS.
  • Assign all required training to BioCryst users that need access to the DMS and QMS and ensure all training has been completed prior to granting system access.
  • In collaboration with IT team members, and as Quality systems administrator, support all DMS, QMS, and LMS upgrades, including updates made at regular intervals, by reviewing for impact and completing testing/validation accordingly, where required.
  • Set up new employees in the LMS and manage the curricula for all BioCryst employees based on input and feedback from the individual managers and their reviews per the BioCryst SOPs and policies.
  • In collaboration with system vendors, work to resolve issues with system process flows that impact the documented processes.
  • Collect and report metrics for the DMS, QMS and LMS as they relate to support and administration activities (e.g., late training, overdue actions, training assignments, etc.) to all levels of management and in the Quality Council and Quality Management Review Meeting.
• Provide support and contribute to other Quality Assurance activities as assigned.

Qualifications

• Extensive knowledge of ISO 13485, 21 CFR 820, EU MDR with ability to design and implement QMS enhancements in alignment with these requirements.
• Knowledge of US, EU, ICH Regulations, guidelines and requirements.
• Proven track record of leading CI projects within QA/QMS processes.
• Thorough knowledge of administration of electronic Quality Systems and legacy paper systems for Quality processes supporting GxP activities.
• Demonstrated ability to work effectively in cross-functional team environment and independently in a remote work setting, as necessary.
• Proficient in working with people and information, making decisions, problem solving, and leadership.
• Excellent problem-solving and decision-making skills.
• Strong written and verbal communication skills.

Skills

• Strong knowledge of MS Office, including Word, Excel, PowerPoint and Outlook.
• Excellent organizational skills and the ability to manage multiple projects with timelines.
• Strong written and verbal communication skills.
• Excellent problem-solving and decision-making abilities.
• Proficient in cross-functional teamwork and remote work settings.
• Leadership capabilities and ability to drive process improvements in a regulated QA/QMS environment.

Education

• Bachelor’s degree in Business Administration (or similar field), preferably with a technical concentration (IT, Business Systems, etc.). Seven or more years of experience in QA Management Systems in a pharmaceutical/biotech environment, with at least five years in administration of quality systems such as document and/or learning management.