Senior Manager, Quality Assurance

Position Summary:

The Senior QA Manager will be responsible for the quality oversight and routine batch production activities at our Contract Manufacturing Organizations (CMO) for assigned products throughout the product lifecycle. The ideal candidate will have extensive experience related to GMP manufacturing, ensuring products are produced according to GMP, regulatory requirements and Apellis specifications to support clinical and commercial programs based on global alignment.

Key Responsibilities Include:

• This individual will perform and/or oversee cGMP Quality Assurance activities associated with clinical and commercial drug product manufacture, and finished goods.
• Accountable for ensuring product is dispositioned to meet Apellis' timelines for distribution.
• Responsible for coordinating with International Quality team members to support further regional product release and regulatory filing/distribution requirements.
• Responsible for providing inputs for the continuous monitoring of GMP compliance of the supply chain, including evaluation of supplier quality incidents and escalation to Senior Management as risks arise
• Conduct Risk assessments with close collaboration with cross-functional team members.
• Work with cross-functional team to compile and provide relevant batch and quality documentation to Strategic Business Partners.
• Be the point of contact and coordinate review and approval of Quality Events by Strategic Business Partners in accordance with strict timelines.
• Supervising the company's systems and operations related to the products and processes included in the license thereby ensuring compliance with applicable regulations.
• Keeping up to date with regulatory developments impacting the company's activities.
• Ensuring alignment with company standards
• Support of global & local QMS management with respect to applicable requirements
• Track progress of requests to/from Contract Service Providers (CSPs) and Strategic Business Partners, including monitoring status and due dates of action items to drive compliance and on-time completion of activities.
• Manage processes and communications with Strategic Partners to ensure compliance with Quality Technical Agreements.
• Support Apellis with EX-US launch activities by retrieving documentation for the regulatory filings with the CSPs.
• Work with key stakeholders to assure resolution of compliance issues.
• Identify, communicate, and review Quality issues, develop solution proposals and participate in investigations as appropriate.
• Ensure appropriate escalation of quality events.
• Support the continuous improvement objectives involving the Quality organization.
• Participate in inspection related activities, gap assessments, and response/mitigation activities.
• Participates in collation of metrics to evaluate quality performance of CSP or Strategic Business Partner.

Education, Registration & Certification:

• BA/BS (MS or Ph.D. preferred) in any Life Science discipline is required.
• Lean six sigma / Kaizen or green/black belt is a plus.

Experience:

• 6 years of experience in Quality within regulated industry with increasing responsibilities (pharma/biotech).

Skills, Knowledge & Abilities:

• Ideal candidate will have broad experience in product development, clinical operations, regulatory compliance, quality management systems, IT systems, training and education.
• Knowledge in Aseptic fill finish operations a must.
• Good knowledge of project management preferred.
• Strong written and verbal communication skills are a must.

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:

• 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 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 or follow us on and

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.