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. By harnessing advancements in genetics, immunology and neuroscience, we are pioneering the development of potential therapies to counteract the devastating progression of neurodegeneration. 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:
- Bachelor’s degree in biological sciences or related field with 12+ years in pharmaceutical or biotech settings.
- 6+ years in Quality settings.
- Knowledge of global cGMP regulations and ICH guidelines for pharmaceutical/biotech products.
- Proven track record to manage and resolve Quality Events (Deviations, CAPAs, Change Controls, Complaints) with cross functional department collaboration.
- Experience supporting global Regulatory Authority GMP Inspections.
- Excellent communication and interpersonal skills.
- Attention to detail and strong project management skills.
- Experience with clinical stage and commercial CMO operations.
- Familiarity with monoclonal antibodies, recombinant proteins, and cold chain inventory.
- Proven leadership in deploying cross-functional resources to meet corporate objectives.
- Strong analytical skills for assessing complex issues and proposing solutions.
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At Alector, our vision is bold, people are our priority, and our values are at the core of everything we do. Our dynamic and flexible environment encourages our teams to experiment, take ownership of decisions, and question convention to solve complex problems. We value shared wins, perseverance, and a growth mindset, which drives us forward, together.
Among the things you'll discover at Alector from your very first day are our committed and driven colleagues, a bold company vision, and new, modern offices designed to inspire innovation and collaboration in South San Francisco, right at the heart of Biotech Bay. Our benefits are thoughtfully designed around Alectorians and their loved ones and include flexible hybrid work options, competitive compensation, and comprehensive and unique benefits that enhance your health and well-being. Come join us!
We believe that hard-working teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, or disability status, or any other characteristics protected under applicable federal, state, or local laws.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform essential job functions, and receive other benefits and privileges of employment. Please contact us to request accommodation.
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