Sr. Manager, Quality Systems & Continuous Improvement

COMPANY:

At BioCryst, 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 www.biocryst.com or follow uson LinkedIn and Instagram.

JOB SUMMARY:

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 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.

REQUIRED EDUCATION / EXPERIENCE / SKILLS:

• Bachelor's degree in Business Administration (or similar field), preferably with a technical concentration (IT, Business Systems, etc.) with a minimum of seven (7) years' experience in QA Management Systems (or similar) within a pharmaceutical or biotech environment or an equivalent of education and experience. Five (5) years (within the total experience required) should be in administration of quality systems such as document and/or learning management.
• 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.
• Strong understanding and intermediate to advanced software skills (e.g., Microsoft Excel, PowerPoint, Microsoft Project).
• Excellent organizational skills and the ability to work on multiple projects with competitive timelines.
• Strong attention to detail and respect for the need of accurate information.
• Excellent communication and presentation skills.
• Ability to maintain high ethical standards.
• Proficient in working with people and information, making decisions, problem solving, making a difference, and working in a leadership role.
• Demonstrated ability to work effectively in cross-functional team environment and independently in a remote work setting, as necessary.
• Excellent problem-solving and decision-making skills
• Strong knowledge of MS Office, including Word, Excel, PowerPoint and Outlook.
• Strong written and verbal communication skills.

The statements in this position description are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time.

BioCryst is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and/or other protected class characteristics. Additionally, BioCryst is committed to achieving its business objectives in compliance with all federal, state and local law.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.