Associate CQA Director

At Alector, our mission is to develop therapies that empower the immune system to cure neurodegeneration and cancer. Our team is dedicated to developing cures for some of the most challenging diseases facing our society. We are supported in this mission by world-class scientists and board members, leading healthcare investors, and among the most innovative pharma companies.

Job Responsibilities

• Executes the direction for CQA’s approach in collaboration with the Quality Leadership Team/CQA Management Team and relevant stakeholders. Directs the development and implementation of this approach to ensure an effective CQA oversight and audit program which complies with regulatory requirements and stakeholder expectations.

• Manages the audit program including oversight of Contract Auditors, management of audit plans, reports, and responses, as well as evaluation and refinement of Audit tools and templates (for Clinical Investigator Sites, Vendors, and Internal Audits). Manages development and maintenance of the schedules for internal and external audits (e.g. investigator sites and vendors)

• Provides QA support to PV for process improvements, compliance initiatives, issue resolution, etc.

• Assures the creation and implementation of the appropriate strategic risk-based support model for each program. May represent CQA on Study Teams, Clinical Teams and/or Project Teams.

• Ensures the development of short and long-term risk-based quality strategies in support of development programs based on current regulatory interpretations, and drives their implementation locally and globally as appropriate

• Provides strategic direction to ensure that the appropriate processes and procedures are in place for CQA

• Responsible for quality oversight to support development programs and submissions by establishing strong collaborative relationships with internal CQA key stakeholders and development functions, as well as of relevant external stakeholders

• Support Sponsor GCP Inspection Readiness and Management for Clinical Sites and Sponsor activities including review and staging of regulatory authority expected and actual inspection requests (FDA, EMA, MHRA), organizational preparation activities (mock inspection, storyboarding, etc.) and management of in-process global regulatory authority inspections at Clinical Sites.

Required Qualifications

• Minimum 5 years CQA, preferred 10 years experience in Clinical Quality Assurance

• Experience conducting and managing Investigator Site, Vendor, and Internal GCP audits

• Experienced in GCP Sponsor and Clinical Investigator Site Inspection Readiness/Preparation

• Expert knowledge of the pharmaceutical and/or CRO industry, pharmaceutical R&D processes and global regulatory agencies, regulations, and procedures

• Proven experience with GCP Quality Management Systems and quality support and oversight of global clinical trials and drug development operations

• Practical experience and understanding in GLP and/or GVP

PREFERRED QUALIFICATIONS:

• Experienced in SmartSheet and Veeva

$125 - $175 an hour

Hourly ranges will be determined by the candidate’s level, qualifications, skill set, and experience  This role will be 40 hours per week and will be required to attend meetings in Pacific time.

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At Alector, we believe that high-performing teams include people from a wide variety of backgrounds and experiences who can challenge each other’s assumptions with new 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, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Alector is a phenomenal place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a cure, where you’ll drive growth, this is the role for you. There is no limit to how far you can go with us.

Benefits

While we’ve focused on what to look forward to in your first year and beyond, Day One is great, too: committed and driven colleagues, an ambitious and important company goal, state-of-the-art brand-new brightly-lit offices in the heart of the biotech area, competitive compensation and benefits. But these things matter only if you’re excited to build and own something great, and tackle these challenges with us. Come join us.