What are the responsibilities and job description for the Associate Director Quality Operations position at Alector, Inc.?
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare investors, and pharma company partners, who share in our commitment to bettering the lives of patients and realizing a world where we make brain disorders history.
The Associate Director, Quality Operations is responsible for working cross-functionally with internal collaborators and external partners and vendors to ensure compliant and timely execution of all deliverables.
Essential responsibilities include but are not limited to :
- Manage global GMP (CMO / CDMO) vendor activities, including batch records, change controls, deviations, and CAPAs.
- Act as Alector's representative during vendor manufacturing operations.
- Ensure GMP vendors comply with Alector requirements, their QMS, and global regulations.
- Review CMO / CDMO SOPs, manufacturing documents, validation protocols, reports, label proofs, and release data.
- Oversee Quality Specialists to ensure timely and compliant batch record review and lot disposition for Drug Substance, Drug Product, Packaging, and Labeling.
- Release Investigational Product (IP) to clinical sites and support QP release in compliance with regulatory filings.
- Conduct CMO / CDMO site visits for GMP compliance guidance and issue resolution.
- Participate in risk-based audit schedule development and GMP audits by external partners and internal teams.
- Lead remediation of GMP audit findings and review / approve GMP Vendor CAPAs.
- Support Pre-Approval Inspection (PAI) readiness and host PAIs.
- Lead continuous improvement initiatives for CMC activities, including manufacturing, testing, and defining GMP policies.
- Represent GMP QA in project teams, providing status reports and quality metrics.
- Provide SME input and review of regulatory filing documents and CMC query responses.
- Collaborate with Alliance partners to ensure Quality oversight and availability of clinical supplies, maintaining compliance with global regulatory filings.
Qualifications :
188,821 - $204,229 a year
Base salary ranges will be determined by the candidate’s level, qualifications, skill set, and experience.
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Salary : $188,821 - $204,229
