GxP Training and Administration Manager

Position Summary:

The GxP Training and Administration Manager will oversee the Learning Management System (LMS), manage the LMS and associated processes, and develop training as needed. In addition, this position will ensure that GxP Staff meet compliance requirements relating to knowledge, skill, and practices necessary successful job performance and remain prepared to perform assigned tasks. This includes overseeing the development, deployment, and maintenance of GxP training matrices to ensure alignment with role-specific competencies, managing onboarding compliance to confirm that new hires are trained in a timely and comprehensive manner, and coordinating the accurate and consistent rollout of GxP training and procedural updates across the organization. The role will also support departmental training managers by facilitating collaboration, providing guidance on best practices, reporting, communication, and ensuring consistency in training strategy and execution. Furthermore, this position will be responsible for managing the annual review of training requirements within departments to ensure continued relevance and alignment with evolving regulatory expectations and business needs.

Key Responsibilities Include:

• Serve as the primary administrator for ComplianceWire and manage overall LMS governance.
• Provide Organization Administration level support.
• Perform routine LMS maintenance activities, escalate issues as needed, and oversee system performance.
• Manage user access, role assignments, and onboarding/offboarding processes to ensure timely access to training, accurate deployment of curricula, and completion of onboarding GxP training requirements.
• Support LMS system upgrades, validations, integrations with HR and document management systems, and change control processes.
• Maintain system governance documentation, including procedures, work instructions, user guides, and validation records.
• Oversee and ensure onboarding compliance by verifying that GxP training is deployed accurately and completed within the required timeframe for new hires and job changes.
• Lead and coordinate the annual review of departmental training curricula and role assignments to ensure relevance, completeness, and alignment with quality system updates.
• Participate in internal and external audits, provide LMS-related documentation, and support inspection readiness activities.
• Facilitate ongoing communication with cross-functional stakeholders to align on training priorities, share compliance updates, and promote continuous improvement in training processes.
• Train and support LMS users, including departmental Training Managers and Administrators, by providing guidance, tools, and oversight to ensure consistency, accuracy, and compliance in training deployment and maintenance.
• Develop, deploy, and maintain GxP training curricula and role-based assignments in partnership with functional departments, ensuring alignment with QMS requirements and timely delivery of procedural updates.
• Develop and deploy learning assessments and support the development of training content.
• Create and maintain reports, dashboards, and training compliance metrics, and regularly communicate key findings, trends, and areas for improvement to stakeholders and leadership.
• Monitor training program effectiveness and identify gaps, recommending improvements based on performance metrics and stakeholder feedback.
• Manage and maintain GxP training matrices with departmental training managers, when necessary, to ensure training assignments are current, role-specific, and aligned with regulatory and operational requirements.
• Act as the point of contact for Helpdesk to resolve system issues and requests.
• Partner with cross-functional teams to create user groups and training curricula tailored to business needs.
• Lead LMS-related projects including system upgrades, UAT coordination, and validation documentation efforts.
• Identify and deploy LMS best practices to enhance system utilization and feature adoption.
• Contribute to quality systems projects and support other system-related tasks as required.

Education, Registration & Certification:

• B.S. in Life Sciences related field.

Experience:

• 5-7 years in biotech/pharmaceutical industry preferred.
• Strong understanding of ComplianceWire is preferred.
• Strong organizational skills and attention to detail.
• Strong communication skills (written & oral)

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 20% travel expected.

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/benefits/ 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 visithttp://apellis.comor follow us onTwitterandLinkedIn

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.