Associate Director, GMP Quality Assurance

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🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $175k - $210k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Erasca, Inc.

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2020

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

💰 $100M Post-IPO Equity on 2022-12

Healthcare • Biotechnology • Pharmaceuticals

Erasca, Inc. is a clinical-stage precision oncology company committed to eradicating cancer by targeting one of cancer's most commonly mutated pathways, the RAS/MAPK pathway. The company is dedicated to developing a modality-agnostic portfolio of therapeutic programs designed to thoroughly shut down the RAS/MAPK pathway, which affects millions of lives globally each year. Erasca is advancing a robust pipeline with the potential to transform cancer treatment and improve the lives of patients suffering from various types of cancer. With a focus on groundbreaking science in oncology, Erasca aims to bring new hope to patients and lead the way in precision oncology innovations.

📋 Description

• Support GMP CMC operations, including review and approval of manufacturer master and executed batch records, Certificates of Analysis, and associated analytical data for GMP products intended for human clinical use • Support GMP/CMC Quality by Design (QbD), risk assessments, and process performance qualification (PPQ)/process validation activities • Work closely with Qualified Persons (QPs) for batch certification and release of drug product and final IMP for EU countries • Assist with management and oversight of Erasca QA contractors supporting GMP QA operations • Perform final product disposition • Review and approve OOS, deviations, product complaints, temperature excursions, corrective and preventive actions, and change controls before and/or after product release • Liaise with internal subject matter experts and third-party/contract vendors • Provide quality oversight for clinical program supply demands domestically and internationally • Develop, review, and support compliance with quality agreements and customer contracts containing quality-related information • Support internal and external compliance audits and vendor management activities • Assist with selection and qualification of GMP vendors, including representing Erasca Quality during Business Review Meetings • Act as Quality Assurance Person-in-Plant representative at Contract Manufacturers during production of critical batches/campaigns as needed • Evaluate, author, and/or review operating procedures and support an integrated cross-functional quality management system • Collaborate with stakeholders and colleagues to establish metrics and report the state of the Quality Management System • Perform duties in accordance with company values, policies, and applicable regulations • Report to the Executive Director, Quality Assurance GMP

🎯 Requirements

• Bachelor of Science in Biology, Chemistry, Physical Sciences, or related degree and/or training or equivalent combination of education and experience in an FDA-regulated environment • Advanced degree in Pharmaceutics, Chemistry or related field with 8+ years of progressive industry experience in pharmaceutical small molecule drug product development • Minimum 8-10 years in a GxP pharmaceutical environment in progressively responsible Quality roles • Minimum of 8 years of GMP QA experience highly desirable • Previous Quality oversight/support experience in solid oral dosage and Biologics manufacturing is required • Experience with electronic document management systems and Quality Management System software platforms is a plus • Previous experience working with FDA and participating in regulatory agency inspections • Previous experience working with non-US regulatory agencies and/or international product supply is a plus • Strong interpersonal, verbal, and written communication skills • Ability to work well in a fast-paced, team-oriented environment • Excellent organizational ability; able to multitask and shift priorities as needed • Strong learning orientation, curiosity, and passion for science and patients

🏖️ Benefits

• Paid Time Off • Holiday and Sick Leave • Medical, Dental and Vision Plans • Short- and Long-Term Disability • Basic and Voluntary Life/AD&D Coverage • Flexible Spending Accounts (FSA, HSA, and Commute) • Critical Illness and Accident Coverage • Pet Insurance • Employee Assistance Program • 401(k) Plan with Erasca contribution • Employee Stock Purchase Program • Annual bonus • Equity grant at hire and annually in the form of the option to purchase stock in the future • Casual, collaborative, and fun work environment