Sr Manager/assoc Director, Quality Systems

Position Summary:

Reporting to the Senior Director, Quality Assurance GMP, the Senior Manager or Associate Director of Quality Systems leads the implementation and management of the Quality Management System at Erasca. This person is responsible for supporting GXP Quality System activities including training, document control, change control, quality events (deviations, product complaints, temperature excursions), corrective & preventive actions (CAPA), audits, and vendor quality management. The position also owns the electronic document management system and is responsible for system maintenance and continuous improvements.

Note this position can be hybrid in our San Diego or South San Francisco locations or fully remote anywhere in the United States. 

Essential Duties and Responsibilities:

• Own GXP Quality Systems including training program, document control, change control, deviations, product complaints, temperature excursions, and corrective & preventive actions (CAPA).
• Develop, implement, maintain, and support 21 CFR Part 11 compliant electronic systems in support of GXP operations, (i.e., Veeva Quality Suite, DocuSign) as Business System Administrator and Business Process Owner, conduct system user training, and ensure continuous improvement to support business needs.
• Oversight and maintenance of the Vendor Quality Management program including development and maintenance of the GXP audit schedule, qualification status of vendors, and along with GMP QA ensures appropriate CAPAs are in place to resolve audit observations.
• Development and oversight of the Internal Audit Program; coordinates, and schedules audits, communicates results to the relevant functional area management, and interacts with various teams to ensure CAPAs are taken to resolve audit observations, as applicable.
• Liaise with all functions to ensure compliance with Quality Management System, including tracking and completion of quality records to ensure issues are resolved in a timely manner and process improvements are identified, captured, and implemented.
• Assist/lead in the development, review, and approval of SOPs for GXP operations and activities.
• Collaborate with key stakeholders and colleagues to establish metrics and report the state of the Quality Management System. Provide management with information on the state/health of the QMS.
• Provide training to contractors/consultants supporting Quality Systems.
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations

Required Education and Experience:

• Undergraduate degree in life science preferred, or comparable experience in an FDA-regulated environment.
• Minimum 8 years in GxP pharmaceutical environment in progressively responsible Quality roles, including at least 4 years of QA systems experience. Experience in a related GXP Quality function (GMP/GCP/GVP/GLP) a plus.
• Previous experience with administration of electronic Document Management Systems. Experience with Veeva QualityDocs and Veeva QMS modules required.
• Experience with development, implementation, and support of Quality Management System software platforms, including knowledge of 21 CFR part 11 requirements, and computer system validation practices.
• Expert knowledge of GXP Quality Systems including training, document control, change control, deviations, product complaints, temperature excursions, and corrective & preventive actions (CAPA).
• Previous auditing experience as well as experience working with FDA/global health authorities and participating in regulatory agency inspections.
• Experience with Supplier/Vendor management and quality oversight of contracted vendors performing GXP activities.
• Strong customer focus with the ability to build relationships and influence across functions and levels of the organization.
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks with excellent attention to detail 
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment. 
• Effective interpersonal and verbal and written communication skills; must be a collaborative team player with a can-do attitude and the ability to identify and implement creative solutions to complex technical problems. 
• Strong learning orientation, curiosity, and commitment to science and patients. 

The anticipated salary range for this position is $165,000-185,000,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etcetera. In addition to base salary, the hired applicant will be eligible to receive an annual bonus and an equity grant at hire and annually in the form of the option to purchase stock in the future for a specified price.