Sr. Specialist, Quality Systems

Position Summary:

Apellis is seeking a Senior Specialist, Quality Systems, a key member of our Global Quality Risk Management team. The role supports the daily operations of the deviation, CAPA, Change Control, and Product Complaints programs.

Senior Specialist, Quality Systems supports evaluating and improving a company's quality systems and technologies. They support program management of deviation, CAPA, change management, product complaints, management review, and quality risk management. They work with end users to coach, mentor, facilitate, or troubleshoot quality system processes. They conduct gap assessments to ensure compliance with regulatory policies and internal guidelines. Using technical skills, they assess system components and suggest improvements. They generate metrics and assess system performance to support oversight and recommend strategies for process enhancement. Good technical, math, leadership, organization, and communication skills are essential for this role.

At Apellis, we combine courageous science and compassion to develop life-changing medicines for some of the most challenging diseases patients face. We advance courageous science. Our goal is to transform treatment for a broad range of debilitating diseases by controlling a part of the immune system known as the complement cascade. We ushered in the first new class of complement medicine in 15 years, and now have two approved medicines targeting C3, the central protein in the cascade. These include the first-ever therapy for geographic atrophy, a leading cause of blindness around the world. 

Key Responsibilities Include:

• Assist with administrating and managing the deviation, CAPA, change control, and product complaints programs, including eQMS admin, developing and communicating oversight tools, facilitating review boards, maintaining SOPs and training materials, and developing end-user tools.
• Manages the receiving and handling (intake, triage, follow-up, product returns, investigation, and reconciliation,) of Product Quality Complaints (drug, device, and combination products) in a manner that complies with global regulatory requirements.
• Facilitate Quality Risk Assessments, investigations, CAPA, change controls, and complaints.
• Support the Quality Management Review
• Regularly generate metrics and communicate (e.g., trends, process) for their effectiveness and provide feedback to the Quality Systems team for action and remediation.
• Ensuring timely closure of quality records in compliance with established procedures.
• Actively participate in continuous improvement initiatives.
• Completes assigned training on-time.
• Other duties as assigned.

Education, Registration & Certification:

• Bachelor's degree in a science, technology, engineering, or mathematics.

Experience:

• 3-5 years of industry experience within Biotech or Pharma field.
• Experience with CAPA, Deviations/Investigations, Change Controls, and/or Product Complaints processes.
• Knowledge of GxPs (GLP, GMP, GCP)
• Proactive in identifying opportunities with a robust solution-minded approach and flexibility to emerging challenges.
• Strong collaborative, influencing, and interpersonal skills with excellent verbal, written, and presentation skills with the ability to deal effectively across all levels of management.
• Ability to understand and translate customer needs for innovative and creative approaches to quality management.
• Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
• The ability to work independently, interact with staff in a fast-paced environment, sometimes under pressure, remain flexible, proactive, resourceful, and efficient, with a high level of professionalism.
• Excellent written and verbal communication skills, strong decision-making skills, and attention to detail are equally important.
• The ability to comprehend regulations and guidance documents, apply critical thinking skills to evaluate requirements, and effectively communicate written and oral findings.

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 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.