Currentjob openings

Director/Sr Director, QA GMP

Position Summary:  

Reporting to the Sr Director QA, the Director or Sr Director QA GMP will lead GMP activities and have responsibility for strategic and tactical oversight of QA GMP & Quality System operations in support of Erasca’s clinical development programs (Phase 1, 2, 3) and planned future commercial launch. This position is also responsible for the development and maintenance of the Quality Management System. This includes establishment, continuous improvement, and ensuring consistent implementation of global quality system policies and procedures. As a key member of the Quality Assurance leadership team, this person will partner with GxP functions to execute GMP and QMS strategies and participate in the further development of a high functioning QA organization. 

Essential Duties and Responsibilities:  

• Oversee (and perform as required) batch release of Drug Substance, Drug Product, Packaging, and labeling runs at Contract Manufacturing Organizations 
• Review and approve testing methodology and specifications for raw materials, intermediates, excipients, APIs, and DPs 
• Oversee quality operations at external manufacturing sites and/or contract analytical labs, including process/method development, qualification, transfer, and validation for API and DP. 
• Review and approve specifications, stability protocols, data. and reports for API, DP, intermediates. and reference standards. 
• Collaborate with CMC and RA in the implementation of API and DP operations at contract vendors in support of global regulatory filings. 
• Maintain and provide oversight of Quality Management Systems including: Deviations and Investigations; Corrective and Preventive Actions; Product Complaints; Change Control; Document Control; and GxP Training. 
• Manage internal audit program, audit schedule, and approved vendor list. May perform both internal and external audits.  
• Evaluate, author, review, and/or approve operating procedures (e.g. policies, SOPs, etc.), and perform other activities in support of an integrated cross-functional quality management system (QMS). 
• Develop quality/KPI metrics to support GMP activities and quality management review. 
• Perform all duties in keeping with the Company’s core values, policies and all applicable regulations. 

Required Education and Experience: 

• Undergraduate degree in in Biology, Chemistry, Physical Sciences, or related discipline 
• 12-15+ years experience including GMP Operations and Quality System management in a pharmaceutical or biotech environment in progressively responsible Quality roles.  
• Solid understanding of US, European, and ROW regulations including application in the day-to-day environment 
• Previous experience working with FDA and participating in regulatory agency inspections 
• Must have good written and verbal communication skills. The ability to tailor communications to all levels in the organization and prepare appropriate updates to functional groups 
• Strong organizational skills that reflect the ability to perform and prioritize multiple tasks seamlessly with excellent attention to detail  
• Demonstrated ability to achieve high performance goals and meet deadlines in a fast-paced environment  
• Excellent interpersonal, communication and influencing skills, including effective writing 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 $190,760 – $240,935. 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.