Senior Director, R&D QA

Position Summary:

The Senior Director of R&D Quality Assurance is responsible for establishing and implementing the strategy for the R&D QA function that provides Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Laboratory Practices (GLP) quality oversight at Apellis. The individual will partner with senior management and stakeholders to develop risk-based, phase-appropriate strategies to ensure that clinical trials and post-approval activities are conducted in compliance with applicable regulations, ICH guidelines, and industry best practices.

Key Responsibilities Include:

• Provide overall R&D QA leadership and strategic development for global R&D QA activities at Apellis, its investigator sites and external service providers to ensure implementation of quality and compliance initiatives for global Phase I - IV clinical studies and marketed product, including establishment and maintenance of phase appropriate quality systems for drug, devices, and combination products.
• Partner cross functionally to enable transparency & escalation of R&D quality risks and issues, collaborating to address challenges and constraints. Provide risk-based rationale to facilitate decision-making, demonstrate sound judgment, and support the development and execution of effective and comprehensive action plans to address quality and compliance risks
• Establish strong partnership with senior leaders and key stakeholders, fostering a commitment to quality and a culture of quality. Interface with key external Quality organizations for development vendors and partners.
• Identify and drive continuous quality process improvements through assessment of audit, inspection and quality event outcomes and identification of trends from internal deviations.
• Assist in the implementation of compliant procedures and operations to ensure a robust quality management system for the conduct of clinical studies and marketed pharmaceutical/medical device combination products.
• Serve as a resource to global clinical and safety personnel on compliance issues, preparations for external inspections, regulatory risk, and process improvement opportunities. Provide guidance and training on relevant GxP regulations and guidelines to cross-functional business partners.
• Review regulatory and corporate compliance risks, altering senior management when needed.
• Assure global regulations are followed for clinical trial and marketed product reporting, including submission of adverse events/SAE reporting and all required clinical reports.
• Assure personnel, documentation (protocols, reports, device labeling, promotional and advertising materials), processes and quality standards meet expectations for regulatory submissions, regulatory authority inspections, and compliance with applicable regulations and guidelines.
• Develop and oversee appropriate Quality metrics and reporting on the state of Apellis' compliance to senior management regarding critical quality and compliance related issues and corrective actions to mitigate risk.
• Assure the quality and integrity of the results from raw data protocols and reports are in compliance with investigational plans, policies, procedures, and applicable government regulations.
• Deliver leadership and technical direction in preparation and hosting of Health Authority Inspections (BIMO, PADE, REMS, etc.) internally, at clinical sites, and at CROs, including follow-up efforts, to ensure successful outcomes and responses to any observations.
• Host GCP and GVP regulatory inspections at Apellis. Lead/oversee management of internal inspection readiness activities throughout program life cycle for study teams
• Direct the internal and external R&D audit programs, including the development of audit plans, priorities and schedules.
• In collaboration with functional area leaders, ensure clinical and pharmacovigilance service providers comply with the applicable quality program and regulations/guidelines.
• Develop and implement Study-Specific Audit Plans and Quality Risk Management Plans for clinical trials.
• Oversee R&D QA incident investigations, including input and approval of plans for resolution of Quality issues including but not limited to the assessment of serious breaches, partnering with internal and external stakeholders to ensure CAPAs are appropriate and effective.
• Proactively provide consultative R&D QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency.
• Function as a member of the Quality Leadership Team (QLT), responsible for establishing the organizational strategy, resource and capacity planning, culture building, talent management, and stakeholder engagement.
• Build strong R&D QA team. Manage and develop staff through empowering team members.

Education, Registration & Certification:

• Master's or bachelor's degree with required years of experience. 

Experience:

• Minimum of 15 years pharmaceutical/medical device R&D QA experience including at least 7 years in a people management role.

Skills, Knowledge & Abilities:

• Strong understanding of R&D Quality for pre-clinical, clinical, and commercial stage work.
• Expert knowledge and in-depth experience of implementation of global regulations in clinical trials, pharmacovigilance, product surveillance for medical device and pharmaceutical manufacturing environments.
• Experience implementing and ensuring GCP/GVP/GLP quality (e.g., GCP oversight, auditing, electronic systems management, global inspection readiness.)
• Proven ability to build and manage a high performing group, including attracting, retaining and coaching top talent.
• Experience leading/hosting regulatory authority inspections and developing responses to regulatory authority inspection findings.
• Proven experience in successfully developing and implementing Quality Risk Management Plans for clinical trials and safety.
• Experience working with CROs, vendors, and relationship management.

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 and bend or stand on a stool as necessary. 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/ 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.