Position Summary:

The IT Business Systems Manager serves as the technology business partner to support and implement innovative process and system improvements. This position will focus on ensuring business processes are matched with agility and high-quality technology solutions. This position will drive the execution of key business priorities with solution enhancements and/or implementations that promote and support efficient and effective processes.

This position is centered around platforms and tools used to oversee and document clinical trials, as well as the processes to collate and submit to health authority agency(s). Key business partner groups include:

• Technical Operations – CMC, Analytical Development, Supply Chain
• Quality – Operations, Quality Control, Quality Assurance, CSV-Validation

Key Responsibilities Include:

• Represents IT as the Technical SME across the business area(s) and technology platform(s).
• 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.
• 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.
• Represents IT in collaboration with Quality Validation and Business System Owner determine Computer System Validation (CSV) impact and requirements.
• 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.
• Facilitates and executes IT Computer System Validation activities, including implementation, system release management, and overall support
• Responsible for Computer System Validation and GxP System Change Control documentation including: System Impact Assessments, Plan(s), Requirements/Specifications, Testing Protocols/Scripts (IQ/OQ/PQ/UAT), Data Migration, Traceability Matrix, Summary Report(s)
• Oversees and provides IT support, including vendor operational and maintenance and oversight to the vendor's SLAs for contracted services and products.
• Identifies and troubleshoots technical and system/process issues to resolution.

Education, Registration & Certification:

• Advanced degree in computer science, technology, operations, or related disciplines required.

Experience:

• Experience supporting heavily outsourced partner/vendor organizations.
• Experience defining data transfer processes & standards and/or data integration mechanisms.
• Experience working in a GxP regulated environment; Computer Software Validation (CSV), and IT SDLC.
• 7 years pharmaceutical/biotech required.
• Understanding of technical IT issues to orchestrate discussions with internal and external technical specialists.
• Must be able to ensure best practices are used for each type of technology infrastructure: client/server, virtual environments (private, AWS, Azure), single or multi-tenant web-based Software as a Service (SaaS) solutions.
• Strong understanding and working knowledge of:
  • • GxP Regulations (FDA, EMA, ICH), including, FDA 21 CFR Part 11. ISO Standards including IDMP
    • Strong understanding and working knowledge of FDA 21 CFR Part 11, 210, and 211, ICH Q8/9/10, and EU Annex 11
    • Experience working in a GxP environment(s) (FDA, EU, MHRA) is required
    • Experience supporting heavily outsourced organizations and working with CDMOs
• Experience with related Technology Solutions/Platforms, including Veeva Vault Quality (QDocs & QMS); SharePoint 0365; ComplianceWire.

Skills, Knowledge & 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.

Physical Demands and Work Environment:

• This is largely a sedentary role; however, some filing is required. This would require the ability to lift files, open filing cabinets. This job operates in a professional office environment and routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.

Travel Requirements:

• Up to 15% travel expected.

Benefits and Perks:

Apellis offers a great benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, 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.