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, our European headquarters is in Dublin, Ireland 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 us on LinkedIn and Instagram.

 

JOB SUMMARY:

BioCryst is a fast-growing pharmaceutical company with an immediate opening for an experienced Assoc. Director, IT Quality and Compliance who can effectively support and manage the company’s compliance and Quality-related activities to achieve regulatory compliance for all computer systems and IT services.  This role will develop strategic plans for complying with regulations governing BioCryst including but not limited to FDA GxPs, EMEA, Sarbanes-Oxley. BioCryst is a cloud-focused organization so this role will need to bring expertise in this area as well as expertise in managing service provides in this area. He or she will ensure systems are compliant, supported, and achieve maximum value for the company. The role reports directly to the SVP, Information Technology and will have a dotted line to the SVP, Quality for GxP validation activities. #LI-Remote

ESSENTIAL DUTIES & RESPONSIBILITIES:

• Develop & support the global information technology compliance program and provide operational leadership for IT quality and compliance
• Ensure that the company meets its IT compliance obligations, working in partnership with key stakeholders in the company that include Quality, Validation, Legal, Finance, and HR
• Draft global IT SOPs and ensure adherence to the organization’s SOPs, IT Controls framework and System Development Life Cycle (SDLC), ensuring current projects meet business and regulatory requirements
• Act as primary contact with responsibility for representing & responding to all IT related audits, GxP inspections and privacy related inspections, work in collaboration with GxP related systems and Financial SOX
• Assess all global software systems for applicability with 21CFR part 11 or Annex 11 or equivalent international regulations. Maintain and manage the Computer System Validation master list
• Review and approve CSV validation plans, validation protocols, traceability matrixes, validation reports or any other associated documents.
• Responsible for IT privacy initiatives to ensure that all computer-based systems comply with internal and external privacy policies and requirements
• Develop and implement monitoring processes to ensure that information systems are implemented and maintained according to corporate policies and regulatory requirements including 21CFR Part 11, Data Integrity, Data Privacy, and Sarbanes-Oxley (SOX)
• Responsible for developing, negotiating, and auditing external service providers (SAAS and cloud) to ensure SLA compliance with internal security and compliance requirements
• Ensure CSV vendor/software providers are qualified for GxP activities.
• Coordinate and prepare reports for various technology management committees with a focus on accuracy, consistency and clarity.
• Report, analyze, audit and develop plans and programs to support continuous quality improvement to IT processes and procedures.
• Manage SOX-related IT General Controls and all policies and procedures related to security controls.
• Oversee maintenance of the IT Business Continuity Plan and regular training for Executive team on the plan.
• Assist in developing and maintain IS policies and procedures that are compliant with regulations.
• All other duties as assigned.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree in Computer Science, Engineering or a Related Field and minimum of 6 years of experience in IT Quality and Compliance or related.
• Professional Auditing certification preferred
• Work history in a biotech or pharmaceutical environment
• In Depth knowledge and understanding of 21CFR Part 11, Data Integrity, GxP activities , Validation Procedures and protocols (IOQ)
• Strong understanding of SOX controls
• Strong understanding of timelines, milestones, and deliverable due dates
• Highly ethical and transparent, with professional sensitivity and care for confidentiality
• Highly organized and ability to manage multiple priorities
• Experience in developing and managing external business partner relationships.
• Knowledge of emerging technologies in Infrastructure IT Systems
• Knowledge of the management of cloud-based environments.
• Knowledge of client server and web-based system development.
• Experience in configuration management.
• Skill in project and resource management.
• Strong interpersonal skills and the ability to work collaboratively and will be an effective communicator with excellent written and verbal communication and presentation skills.
• Ability to work as part of a team, both in a leadership role and as a contributing member of the company.
• Exposure to the following:
  • Cloud-based Infrastructure and Operations services
  • Selecting and managing Managed Service Providers
  • Cyber-security techniques and managements of security-related providers
  • End-Point protection and management
  • Office 365 and all related services/applications
  • VMWare, Azure and Azure AD
  • SharePoint and Teams
• Experience with regulatory guidelines and managing environments containing validated systems
• Direct experience with SOX 404 IT General Controls and managing audit documentation and relationship with auditors.

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.