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**Position Summary**:
The Senior Manager Quality Assurance is responsible for providing the quality oversight of routine GMP batch production activities at our Contract Service Provider (CSP) located in Switzerland.
The Senior Manager Quality Assurance will have a strong scientific background/ education which will enable him/ her to be the point of contact for the day-to-day quality assurance activities for Apellis producing intermediates and drug substance. Furthermore the individual will support the process validation activities for the second generation drug substance (GEN2). 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 Sr. 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.
**Key Responsibilities Include**:
This individual will perform and/or oversee cGMP Quality Assurance activities associated with commercial drug substance, which includes but not limited to:
- GMP Drug Substance Manufacturing Quality oversight of process and method validations, change controls, investigations, and Supplier Qualification.
- Accountable for ensuring product is dispositioned to meet Apellis' timelines for distribution
- Responsible for intermediate and drug substance 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
- Responsible to coordinate with Quality Operations and 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.
- Actively work with cross-functional groups and CSPs to manage receipt, review, approval and storage of documents provided by CSPs.
- Facilitate trending and evaluate 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.
**Accountabilities**:
- Performing deviation investigations, root cause analysis, risk assessments, investigations, CAPAs and change controls.
- Review deviations, investigations, and CAPAs associated with cGMP compliance and supports change controls related to Quality topics through knowledge of quality concepts, investigational techniques, and root cause analysis.
- Conducts Risk Assessments
- Identify and communicate quality or compliance risks and participate in determination of appropriate plan to address 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 intermediate, drug substance.
**Education, Registration & Certification**:
- BS/MS or Ph.D. in any Life Science discipline is required.
- Fluent in German and English language required
**Experience**:
- 5 years of direct Quality Assurance management 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.
- Strong technical knowledge and experience in peptide chemistry, drug substance, desired
**Skills, Knowledge & Abilities**:
- Judgment - Exhibits sound and accurate judgment; supports and explains reasoning for decisions, includes appropriate people in decision-making process, makes timely decisions
- Technical Skills - Pursues train
