IT Business Systems Manager – Quality Systems

Position Summary:

The IT Business Systems Manager will be the IT System Owner to the quality learning management system (LMS), quality management system (QMS), and electronic document management system (eDMS). Their primary role is to partner with the Quality team to ensure the ComplianceWire and Vault Quality solutions are meeting the needs of the cross-functional GxP business community.

This individual must have a deep understanding of the Veeva Vault Quality specifically the QMS Quality Event and QualityDocs applications. Experience with working in a hybrid waterfall - iterative methodology is expected by using an incremental, iterative approach to gather and refine scope with solution options before executing a defined and controlled deployment approach using an adaptive, risk-based GxP system change control process.

Responsibilities:

• Oversees and provides IT support, including vendor operational and maintenance and oversight to the vendor’s SLAs for contracted managed services and products.
• Prioritize activities and solutions in alignment with overall corporate/business strategies. Review, analyze and evaluate business systems and user needs. Responsible for business systems consulting, project planning, prioritization, and implementation of deliverables, including implementations and operations. Ensures documentation of process and system, functional and business requirements, and objectives for technology initiatives.
• IT Technical SME for system activities for system/process enhancements and integration projects. Coordinates support activities across vendor(s) for all support and maintenance and ensures the proper delivery of services, including managed services.
• Identifies and troubleshoots technical and system/process issues to resolution.
• Represents IT in collaboration with Quality Validation and Business System Owner determine Computer System Validation (CSV) impact and requirements.

             o Accountable as the IT System Owner for GxP/CSV solutions. May be called upon to provide evidence of computer system validation and compliance in the case of an audit or inspection.

             o Facilitates and executes IT Computer System Validation activities, including implementation, system release management, and overall support. Computer System Validation and GxP System Change Control documentation may include: System                    Impact Assessments, Plan(s), Requirements/Specifications, Test Scripts (IQ/OQ/PQ/UAT), Data Migration, Traceability Matrix, Summary Report(s)

Skills & Abilities:

• Ability to communicate and work independently with cross-functional/inter-departmental teams and within the framework of the IT organization.
• Must be able to effectively prioritize and plan; must have the ability to address multiple projects and adapt to changing priorities and ensure.
• Self-motivated and passionate to learn and adopt new technology and nimble, pragmatic methodologies. Must be able deal with ambiguity, work through issues with agility but without compromise to best practice processes and documentation.
• Team-oriented and generous in sharing knowledge and enabling others
• Strong communication and facilitation skills to lead teams to establish consensus, ensure clarity and decisions/justifications

Required Work Experience:

• Experience supporting outsourced partner/vendor organizations.
• Experience working in a GxP regulated environment; Computer Software Validation (CSV), and IT SDLC
• Degree in computer science, technology, operations, or related disciplines preferred.
• 5-7+ years pharmaceutical/biotech required

Required Technical Knowledge/Experience:

• Strong understanding and working knowledge of: GxP Regulations (FDA, EMA, ICH), including FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11. ISO Standards including IDMP
• Experience with related Technology Solutions/Platforms, including Veeva Vault Quality (QDocs & QMS); Microsoft SharePoint 0365; UL ComplianceWire
• Veeva Vault Quality Certified Administrator certification is highly desirable

Benefits and Perks:

Apellis offers a comprehensive benefits package, including a 401(k) plan with company match, inclusive family building benefits, flexible time off, summer and winter shutdowns, paid family leave, disability and life insurance, and more! Visit https://apellis.com/careers/ to learn more.

Company Background:

Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that combines courageous science and compassion to develop life-changing therapies for some of the most challenging diseases patients face. We ushered in the first new class of complement medicine in 15 years and now have two approved medicines targeting C3. These include the first and only therapy for geographic atrophy, a leading cause of blindness around the world. With nearly a dozen clinical and pre-clinical programs underway, we believe we have only begun to unlock the potential of targeting C3 across many serious diseases.

For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn

EEO Statement:

Apellis is an equal opportunity employer and complies with all applicable federal, state and local fair employment practices laws. Apellis strictly prohibits and does not tolerate discrimination against employees, applicants or any other covered persons because of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including gender nonconformity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, marital status, AIDS/HIV status, smoker/nonsmoker, and occupational pneumoconiosis or any other characteristic protected under applicable federal, state or local law.

For San Francisco postings: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.  

Other Duties:

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.