Senior Manager, Clinical Quality Assurance

Position Summary:

The Senior Manager of Clinical Quality Assurance will serve as the GCP Quality Lead for assigned studies. In this role, the position will be responsible to drive inspection readiness, facilitate entry/approval of quality issues (including Serious Breach investigations), participate in protocol deviation trend analysis, implementing quality agreements, monitoring CRO KQIs, and review/endorsement of key study specific documents as protocol deviation plan, TMF plan, Monitoring/Oversight plans, etc., and execution of a risk-based audit program.

This role will be expected to routinely interact with external partners that support the clinical development organization, such as CROs, laboratories, and other vendors, to promote collaboration to ensure their systems and processes are following applicable global regulations, guidelines, and standards.

Key Responsibilities Include:

• Participate on cross-functional teams as SME in GCP/GLP/GCLP to provide guidance and risk-based options that promote compliance.
• Review clinical study documents and check for consistency and compliance with relevant regulations, standards and best practices.
• Serve as a quality SME and provide guidance to clinical development personnel performing investigations, root cause analysis, and CAPAs through knowledge of quality concepts and techniques.
• Identify and communicate quality and compliance risks and participate in determination of appropriate planning to resolve and address issues and risks.
• Assist the clinical development organization in establishing procedures to support a risk-based approach to oversight and execution of clinical trials using principles of quality by design (QbD) and quality risk management (QRM).
• Oversight and approval of deviations and CAPAs to ensure high quality content and timely advancement of the record and closure of actions.
• Support development of new and revised existing operational and quality procedures and tools to promote compliance and ensure adherence to regulatory requirements.
• Support the GCP inspection readiness (IR) strategy by leading IR activities for assigned studies and participating in regulatory inspections.
• Collaborate with key stakeholders in the development and implementation of a comprehensive internal (systems and procedures) and external (investigator sites and vendors) audit programs and plans
• Execute the audit program including setting agendas in collaboration with clinical development SMEs, review and approval of audit reports and responses and follow-up on CAPA and effectiveness checks.
• Identify quality process and system improvements and implement timely actions.

Education, Registration & Certification:

• BA/BS (or MS) preferably, in a Life Science discipline

Experience:

• Minimum 7 years of GCP/GLP Quality Assurance experience in regulated industry (pharma/biotech/CRO and medical device)

Skills, Knowledge & Abilities:

• Experience managing internal and contract personnel and external vendors and auditors
• Thorough knowledge of FDA and ICH Good Clinical Practices (GCP) requirements and regulations
• Ability to communicate effectively and non-confrontationally with internal department
• Experience in supporting Regulatory Authority GCP inspections

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 15%

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.