Senior Director, Quality Assurance

About the Role >>> Senior Director, Quality Assurance

As the Senior Director of Quality Assurance, reporting to the Vice President of Regulatory Affairs and Quality Assurance, you will lead all quality activities supporting Olema's pipeline. You will oversee the development, implementation and maintenance of quality assurance systems and activities, and you will lead and build the quality team and function. You will be responsible for managing business relationships with defined stakeholder groups and leaders in the organization for the strategic development and delivery of risk-based quality management and vendor quality oversight.

This role is based out of our Cambridge or San Francisco office and will require 15% travel.

Your work will primarily encompass:

• Contribution to the development of the GxP (GLP, GCP/GMP/GPV) Quality Management Systems, conduct risk assessments, develop and implement risk-mitigations and potential process improvements

• Creation and implementation of a GxP inspection readiness strategy and plan in collaboration with leaders in the R&D organization

• Ensure effective coordination of investigations, root cause analysis, risk assessments and implementation of change control, and corrective and preventive actions to the adhered timelines as appropriate

• Oversee all audits and proactively prepare the organization for inspection readiness

• Lead and manage all regulatory inspections in collaboration with internal and external partners

• Ensure the company is compliant and in a constant state of inspection readiness across all GxP functions through continuous education, training, and internal audits

• Implement and maintain quality metrics, systems and documentation associated with developmental activities of Olema's pipeline

• Prepare the QA function to support registrational trials and ultimately commercial activities

• Collaborate with R&D, product, manufacturing, clinical and regulatory teams, as well as external stakeholders to ensure quality standards are integrated throughout the product life cycle

• Provide strategic and managerial leadership in all Quality related matters ensuring regulatory compliance of operational business matters

• Successful quality oversight of Olema's Quality Management Systems, including Learning Management System and Regulatory Information Management System

And will also include:

• Oversee the development of personnel within the quality department, building a strong team and clear vision to drive best in class performance

• Maintain a pulse on the ever-changing quality assurance landscape and their implementation within Olema, monitor changes in regulations and keep project teams and management informed of such changes

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• Bachelor's degree is required, preferably in a scientific field; advanced degree is a plus

• High level of familiarity with a broad range of compliance areas and ability to assess risk and develop solutions

• Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards

• Strong knowledge of US, EU and other regulatory compliance/GxP requirements

• Deep understanding of small molecule and oncology drug product development

Experience:

• 15+ years of drug development, including 10+ years of quality assurance experience in the Biotech/Pharmaceutical industry

• Strong proven hands-on experiences with GLP, GCP, GPV and GMP compliance matters, and contractor management in the bio/pharma industry

• Extensive experience handling regulatory inspections required

• Previous experience with building and implementing QA systems (QMS, RIM, LMS, etc.)

• Experience supporting products from early-stage development to post-approval

• Experience leading BIMO and PAI inspections

• Experience leading and developing team of individual contributors

Attributes:

• Strong business acumen and ability to successfully work with international and cross functional partners

• Proven ability to deliver on goals within a cross-functional team/partnership environment with a high level of professionalism

• Excellent verbal, written and communication skills

• Able to analyze, define and effectively convey difficult and complex issues in a way that accurately and persuasively communicates the issues to internal and external stakeholders

• Fosters open communication. Listens and facilitates discussion

• Flexible, able to be successful in a past paced, lightly structured environment

The base pay range for this position is expected to be $250,000 - $265,200 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

#LI-CK1