OVERVIEW:

The Manager Quality Assurance is responsible for providing the quality oversight of tech transfer and routine GMP batch production activities at our Contract Service Provider (CSP) located in Germany.
The Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the support for the day-to-day quality assurance activities for Apellis producing drug product and prefilled syringes (PDS). Furthermore, the individual will support the process validation activities for the second-generation. Assures products conform to regulatory requirements, company standards, and satisfies GMP regulations.
Work closely with global Quality organization and CSP partners to ensure quality events are thoroughly investigated, changes are assessed and implemented in a timely fashion and product meets Apellis’ quality standards.
The position includes review and approval of Quality Management System documentation, APQR, batch record review, and batch disposition. Monitors CSP documentation for trends, identifies risks, CAPAs, and recommends remediation plans. Lead cross-functional investigations and risk assessments to resolve potential product quality issues. Plan, organize and prioritize work activities based on goals and objectives for QA.
The Manager is expected to effectively interact with external contract manufacturers, testing laboratories, packaging/labeling/distributors and other service providers, as well as work as part of an internal multidisciplinary team to support manufacturing and testing needs of commercial products globally.

ACCOUNTABILITIES:

• Batch Record Review, Documentation Review
• Review of deviations, investigations, and CAPAs associated with cGMP compliance
• Initiates change controls related to quality topics through knowledge of quality
• Conducts Risk Assessments
• Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address these risks.
• Provide inputs to support continuous improvement of Quality systems and SOPs for supporting GMP activities.
• Assure Corporate Management is informed of any potential compliance issue at the Apellis facilities and contract manufacturers, testing laboratories, packaging/labeling/distributors and other service providers
• Conducts the disposition of drug product (vials & prefilled syringes).

EDUCATION, REGISTRATION & CERTIFICATION:

• BS/MS or D. in any Life Science discipline is required.
• Fluent in German and English language required

EXPERIENCE:

• 5 years working experience in Quality Assurance management or related experience in regulated industry (pharma/biotech and medical device)
• Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, and commercial operations.
• Technical knowledge and experience in aseptic product fill finish manufacturing desired

TRAVEL REQUIREMENTS:

• Expected travel to Contract Service Providers located in Germany
• Additional travel may be required

RESPONSIBILITIES:

• This individual will perform and/or oversee cGMP Quality Assurance activities associated with commercial drug product and prefilled syringes, which includes but not limited to:
• GMP Drug Product/Prefilled Syringes manufacturing Quality oversight of process and method validations, change controls, investigations, and Supplier Qualification.
• Responsible for ensuring product is dispositioned to meet Apellis’ timelines for distribution
• Responsible for Drug Product batches including approval of completed manufacturing batch records, non-conformances and ensuring adequate root cause analysis and investigation activities are performed by CSPs
• Ensure conformance to specifications and GMP regulations
• Supports coordination with Quality Operations and International Quality team members to support further regional product release and regulatory filing/distribution requirements.
• Supports the manager 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.
• Actively work with cross-functional groups and CSPs to manage receipt, review, approval and storage of documents provided by CSP
• Support trending and evaluation of CSP documentation for CAPA and remediation
• Support continued risk-based supplier qualification program and creation or review of related Quality Technical Agreements (QTA).
• Participate in various cross-functional projects supporting continuous improvement and new programs
• Support regulatory inspections and external audits as needed
• Other duties as required

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.

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