Senior Director, Clinical Quality Assurance

South San Francisco, CA /
Quality Assurance /
Full-time
/ Hybrid
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.

We are seeking a highly motivated individual to join as Senior Director, Clinical Quality Assurance at our South San Francisco location. The successful candidate will work cross-functionally to develop and implement quality systems and processes to meet all US, EU and potentially global, Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Distribution Practice (GDP), and Good Pharmacovigilance (GVP) requirements. The position will report directly to the Vice President, Quality.

During the first year, your responsibilities and goals will include:

    • Develop and implement GCP, GLP quality systems in accordance to ICH, FDA, EMA and global competent authority regulations and industry guidances
    • Prepare and implement audit plans and audit CAPAs for all CROs, testing and animal laboratories, clinical sites, and internal Alector departments.
    • Lead and ensure inspection readiness activities for all internal and external entities
    • Lead and host GCP, GLP, GVP inspections. Follow up to any responses and CAPAs
    • Develop, implement and manage the deviation and CAPA systems
    • Develop and implement overall GCP strategy, performance metrics, analytics and reports
    • Develop the GCP QA organizational strategy and lead/mentor the respective teams

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

    • Bachelors degree in biological sciences or related field with minimum of 15 years’ experience in a pharmaceutical setting. Advanced degree and experience with neurological degenerative diseases/therapeutic areas is desirable.
    • Ability to mentor, lead both directly and through influence.
    • Develop teams to engage collaboratively and constructively
    • Proven, extensive knowledge of worldwide GCP regulatory requirements, industry practices, and ability to apply concepts. Experience with GDP, GVP and GLP.
    • Experience in crafting and implementing quality systems and risk management tools
    • Experience with monoclonal antibodies, recombinant proteins, and cold chain inventory
    • Experience leading/hosting US and international health authority inspections/interactions
    • Excellent interpersonal, verbal and written communication skills are critical in our collaborative work environment
    • Experience developing and managing budget of department
    • Must demonstrate high organizational, prioritization and management proficiencies
    • Ability to deliver in a fast-paced, small company environment and tenacity to seamlessly adjust workload based upon changing priorities
#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!

Base salary ranges from $50,000 to $300,000 and will be determined by the candidate's level, qualifications, skill set, and experience.

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.