Vice President, Quality Assurance

Vice President, Quality Assurance

South San Francisco, CA /

Quality Assurance /

Full-time

At Alector, our mission is to develop therapies that empower the immune system to combat neurodegeneration and cancer . Our team is solely 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, leading healthcare investors, and pharma company partners who share in our commitment to bettering the lives of patients.

Would you like to scale Alector's Quality Assurance organization to meet our growth trajectory and accommodate the ever-evolving regulatory environment? Join us as an important influencer in solidifying our quality model. If your track record includes building a successful clinical quality system that is complementary to the manufacturing quality framework, help us scale as we move towards commercialization.

As our Vice President, Quality Assurance, you'll report to the SVP, Regulatory, Pharmacovigilance and Quality Affairs. You'll partner closely with Alector's leadership team to refine our overall GxP strategy and QA plan in alignment with both business objectives and regulatory requirements. Quality Assurance develops and implements all GxP related to manufacturing, non-clinical, clinical, and pharmacovigilance activities, including, but not limited to research activities, clinical trial management, and pharmacovigilance system oversight. You'll ensure that Alector operates under applicable regulatory requirements, guidelines, laws, and established standards and practices. You'll also prepare the organization for commercialization and pre-approval inspection plans.

During your first year, your goals will include:

• Collaborate with senior leadership to provide strategic and technical leadership of Quality Assurance activities and outcomes. You'll lead a culture of Quality by conceiving, collaborating, and supporting the implementation of specific actions, processes, and behaviors.
• Help to implement, monitor, and promote good practice of all Quality Assurance Systems to ensure compliance with relevant FDA and EU regulations/directives/requirements and ICH guidelines.
• Establish required phase-appropriate GxP systems for Alector, including prioritization, and timeline oversight.
• Evolve, audit, and monitor Standard Operating Procedures (SOPs) and Work Practices (WPs) to ensure they are in accordance with GCP and GLP guidelines and meet local regulatory requirements. Carry out corrective actions for identified deviations.
• Be responsible for CQA validation and audit of computer systems in support of research, development, global operations, and global pharmacovigilance.
• Partners with research staff in study design, data collection, and analysis, reporting activities that support quality improvement interventions, transparency, compliance with regulatory standards, and provide performance monitoring.
• In coordination with the SVP and peers within the Global Quality organization, develop and implement a common platform of quality and compliance systems, tools, procedures, and standards.
• Work to develop a quality CMC strategy via objectives and plans to ensure quality oversight, timely resolution of issues, and early intervention to assure compliance.
• Review Validation Master Plans and protocols for CMOs to implement in order to ensure requirements for BLA filings are met.
• Direct and mentor a team of dedicated and exceptional Quality Assurance professionals.
• Accountable for training and education on GxPs, SOPs, and WPs.
• Accountable for the preparation and conduct of all inspections by any regulatory authority.
• Serve on Joint Steering Committees for Alector in partnerships with CDMOs and CROs.

We'd love to hear from you if you have:

• Minimum 15 years of experience in the biotechnology industry with at least 10 years in Quality, and at least 7 years in a leadership role.
• Bachelor's degree in a scientific field or relatable field required; Master's or Ph.D. strongly desired.
• Track record of establishing Quality systems in a phase-appropriate manner.
• Proven success with establishing a strong Clinical QA team.
• Experience with cGMP requirements for Phase III and commercial products and with US and International regulatory authority inspection requirements and first-hand experience hosting pre-approval inspections.
• Success in collaborating on IND, BLA/NDA, and MAA submissions for novel products.

#LI-BL1

#LI-Hybrid

Alector is a phenomenal place to learn and grow. Alector is a dynamic environment where teams are encouraged to experiment, take ownership of decisions, and question convention to solve complex problems. At Alector, we value shared wins, perseverance, and a growth mindset.

Alector was named on Fortune's " Best Workplaces in Biopharma " top list for small and medium-sized companies for the second year! And we moved up from #16 to #11 in 2022 .

Among the things you'll discover at Alector on Day 1 and throughout your tenure: Committed and driven colleagues, a bold and important company goal, brand-new brightly lit offices in Oyster Point, right at the heart of Biotech Bay. Alector offers flexible remote work options, and competitive compensation and benefits. Come join us!

At Alector, 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.

Employees of Alector working on-site are required to be vaccinated against COVID-19, and are required to provide proof of vaccination. Employees may be entitled to an exception or reasonable accommodation if they cannot be vaccinated because of a disability/medical necessity, or sincerely held religious belief.

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.