Assoc Director, GMP Quality Assurance

Position Summary: 

Reporting to the Executive Director, Quality Assurance GMP, the Associate Director, Quality Assurance GMP supports GMP clinical manufacturing operations, including product release, analytical data review, and approval of quality events. This person is a Quality point of contact for internal and external customers and ensures compliance with company policies and procedures and applicable domestic and international standards and regulations.

Essential Duties and Responsibilities:

• Support GMP CMC operations, including review/approval of Manufacturer master and executed batch records, Certificates of Analysis, and associated analytical data of GMP products intended for human clinical use (Drug Substance, Drug Product, and Investigational Medicinal Product), to include biologic and small molecule products. Supports GMP/CMC Quality by Design (QbD), risk assessments, and process performance qualification (PPQ)/process validation activities
• Works 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 prior to and/or after product release.
• Liaise with internal subject matter experts and 3rd party/contract vendors.
• Provide quality oversight for meeting clinical program supply demands, both domestically and internationally.
• Develop, review, and support compliance to quality agreements, and other customer contracts containing quality related information.
• May support both internal and external compliance audits. Assist with vendor management activities for GMP vendors including review and approval of audit agendas, reports, and corrective and preventive actions.
• Assist with selection and qualification of GMP vendors including representing Erasca Quality during Business Review Meetings (BRMs).
• May act as Quality Assurance Person-in-Plant representative at Contract Manufacturers during production of critical batches/campaigns.
• Evaluate, author, and/or review operating procedures (e.g., policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS).
• Collaborate with key stakeholders and colleagues to establish metrics and report the state of the Quality Management System.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations.

Required Education, Experience and Attributes:

• 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 GxP pharmaceutical environment in progressively responsible Quality roles. Highly desirable to have a minimum of 8 years of GMP QA experience. Quality Systems experience a plus.
• 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 – can easily multi-task and shift priorities as needed.
• Strong learning orientation, curiosity, and passion for science and patients.

The anticipated salary range