Senior Manager, Quality Operations - Temporary

August 8

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Alector

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We are harnessing the immune system to treat neurodegeneration and cancer.

Biotechnology • Neurodegenerative disease • Neurodegeneration • Immuno-neurology

51 - 200

💰 $133M Series E on 2018-07

Description

• Manage Alector global GMP (CMO/CDMO) vendor activities including batch records development and approvals, change controls, deviations and Corrective Actions and Preventive Actions (CAPAs). • Represent Alector as a person-in-plant during vendor manufacturing operations. • Ensure GMP vendors operate in compliance with Alector requirements, their internal Quality Management System (QMS) requirements and applicable global regulations and guidelines. • Review CMO/CDMO SOP’s, Master and completed manufacturing documents, validation protocols, validation reports, label proofs and release data. • Oversee the activities of Quality Specialists to ensure batch record review and lot disposition related activities for Drug Substance, Drug Product, Packaging, and Labeling are conducted in a compliant and timely manner according to relevant Alector SOPs. • Perform release of Investigational Product (IP) to clinical sites and support QP release to clinical sites in compliance with all country-specific, currently approved regulatory filings. • Perform CMO/CDMO site visits to provide GMP compliance guidance and/or resolve quality issues. • Participate in and support management in the development of risk-based auditing schedules. • Participate in GMP audits of Alector conducted by external partners as well as internal audits. • Lead remediation of GMP audit findings, including review and approval of GMP Vendor CAPAs. • Support Pre-Approval Inspection (PAI) Readiness activities and provide support for hosting PAIs. • Lead continuous improvement initiatives to support CMC activities including manufacturing, testing, and defining GMP policies and procedures. • Represent GMP QA in project teams, provide status reports and quality metrics, and advise on GMP compliance. • Provide SME input to and review of regulatory filing documents and CMC query responses. • Work closely with Alliance partners to ensure Quality oversight is maintained and clinical supplies are available to meet development timelines and clinical study starts, while maintaining compliance with regulatory filings globally. • Provide or support timely response to all product complaints.

Requirements

• Bachelor’s degree in biological sciences or related field with a minimum of 10 years’ experience in a pharmaceutical or biotech setting. • Minimum of 2 years’ experience in a Quality setting. • Knowledge of global cGMP regulations and ICH guidelines covering good manufacturing practices in the development, manufacturing, delivery, and control of pharmaceutical or biotech products. • Track record of managing compliance audits, identifying compliance risks and recommending corrective actions, and authoring SOPs. • Experience in supporting global Regulatory Authority GMP Inspections. • Excellent communication and interpersonal skills for effectively working with internal and external personnel at all levels. • Excellent attention to detail and strong project management skills. • Experience overseeing clinical stage and commercial CMO operations. • Experience working with monoclonal antibodies, recombinant proteins, and cold chain inventory. • Proven ability to lead initiatives, deploying both internal and external cross-functional resources, in a compressed timeline to meet corporate objectives. • Ability to assess complex issues, break them down into components and propose viable solutions.