Executive Director, Quality Control

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team you will join other outstanding Revolutionariesin a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Playing a critical role as the QC group leader and QC subject matter expert (SME) within Analytical Development (AD) & Quality Control (QC) Pharmaceutical Development and Manufacturing (PDM) department the position will be responsible for managing clinical and commercial Quality Control (QC) activities from early to late phase development process validation commercial launch in support of RevMeds pipeline development. The candidate will also be responsible for post-approval QC related activities including commercial supplies lifecycle management regulatory submissions (e.g. CBE PAS).

• Partner with senior leadership on QC-related strategic development and implement QC policies and practices.

• Lead the QC team providing technical and strategic leadership for day-to-day QC activities supporting clinical and commercial programs. Responsibilities include preparation for commercial product launches management of quality events (e.g. lab investigations for OOS/OOT deviations CAPAs).

• Direct key QC programs including stability reference standard raw material QC quality systems procedures and documentation (e.g. SOPs) PAI readiness and regulatory inspections.

• Manage the selection oversight and performance management of contract organizations (COs) ensuring the effective outsourcing and execution of clinical and commercial QC activities.

• Author review and approve QC-related documentation including analytical methods protocols reports and regulatory submissions.

• Partner with cross-functional teams such as CMC Regulatory Affairs Drug Substance Drug Product Supply Chain and Quality Assurance to ensure timely achievement of project milestones and objectives.

Required Skills Experience and Education:

• BS MS or PhD in Chemistry Pharmaceutical Science or a related field.

• 20 years of relevant industry experience in small molecule Analytical Development and Quality Control with at least 8 years in a senior leadership role.

• Deep knowledge of global and regional regulatory guidelines (FDA EMA ICH USP etc.) particularly in areas such as method development/validation process validation product launches commercial manufacturing and post-approval QC requirements.

• Extensive knowledge and expertise in cGMP compliance and quality control strategies and industry best practices.

• Strong analytical and critical thinking skills with a solid ability to make risk based and data-driven decisions.

• Excellent scientific business and technical communication skills with strong cross-functional collaboration and strategic planning capabilities.

• Proven ability to manage multiple priorities and thrive in a fast-paced dynamic and innovative environment.

• Experience with global regulatory submissions including IND IMPD NDA MAA and JNDA.

Preferred Skills:

• PhD in Chemistry. #LI-Hybrid #LI-GL1