Black Diamond Therapeutics is a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies. Black Diamond targets undrugged mutations in patients with genetically defined cancers for whom limited treatment options currently exist. Black Diamond is built upon a deep understanding of cancer genetics, protein structure and function, and medicinal chemistry. The Company’s proprietary technology platform, Mutation-Allostery-Pharmacology, or MAP, platform, is designed to allow Black Diamond to analyze population-level genetic sequencing data to identify oncogenic mutations that promote cancer across tumor types, group these mutations into families and develop a single small molecule therapy in a tumor-agnostic manner that targets a specific family of mutations.

Black Diamond Therapeutics (BDTX), a clinical stage company, based in Cambridge Massachusetts is seeking an experienced Associate Director/Director of Quality Systems and Compliance to play a critical role in development,  maintenance and execution of  robust Quality Management System (QMS) strategies that enables innovation, productivity, continuous improvement, and adherence to applicable regulations for GxP compliance. The Director of Quality Systems and Compliance will advance a proactive Compliance Strategy and will also be accountable for automation and implementation of electronic Quality Management Systems infrastructure for the company.

Under the direction of the VP of Quality the role involves but is not limited to the following:

• Help define phase appropriate strategy for development and deployment of the company GxP Quality Manual and robust Quality Management System to ensure compliance.
• Manage and oversee the creation and maintenance of SOPs, training programs, deviations, CAPAs, change control, vendor qualification/auditing, and the documentation control and archival processes of these activities in the QMS
• Lead and partner with internal departments and key stakeholders to develop and support the Documentation/data Management System, Learning Management System and Quality Management System process implementations and improvements that meet business and regulatory requirements.
• Own and drive development & implementation of electronic Quality Management Systems for the company.
• Participate and help lead inspection readiness activities and assist in the management of internal and vendor audits and resolution of findings within the Quality organization.
• Will be responsible for the development of Quality System processes, procedures and corresponding controlled documentation and systems.
• Monitor the overall health of the QMS effectiveness and reporting of QMS KPI to cross-functional teams and driving continuous improvements.
• Assists Head of Quality during Regulatory Agency Inspections.
• Actively participate and lead the preparation of Quality Management Reviews and Quality Improvement plans.
• Manage Documentation lifecycle process and maintain periodic review process for documents as appropriate.
• Serves as subject expert and point of contact for staff, providing information and guidance on regulations and procedures related to Quality Systems, Computer Validation and Quality.

• A minimum of a Bachelor’s Degree in Science, Information Science or equivalent technical discipline is required

• A minimum of 10-15 years of experience in the pharmaceutical, biotechnology industry in quality management and compliance.
• Expert knowledge and experience in computer system validation requirements per 21 CFR part 11 Electronic Records and Signatures and other applicable regulations and guidance.
• Experience in design, development and/or deployment of Quality Management Systems supporting pharmaceutical product development and commercialization
• Prior experience in project management, business analysis and implementation of electronic quality systems platforms as used in the pharmaceutical industry environment
• Strong analytical skills and experience leading/managing  risk-based QMS programs for outsourced development and manufacturing.
• Prior experience in information systems quality assurance and validation.
• Ability to travel domestically and international to CDMOs and Vendors.
• Experience implementing eQMS platforms
• Prior experience working in small or mid-sized biotech is preferred
• Working knowledge of common office and quality computer programs such as Microsoft Word, Excel and Microsoft Project.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities
• Previous experience managing direct reports is a plus.
• Maintains professional expertise and knowledge of local and international regulations
• Ability to travel 10 -20 % of time.

Work Environment:

This job operates in a professional office environment. This role routinely uses standard office equipment. 

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to successfully perform he essential functions of this job.

While performing the duties of this job, the employee is occasionally required to stand; walk; sit; used hands to fingers, handle, or feel objects, tools, or controls; reach with hands and arms; climb be stairs; talk or hear. The employee must occasionally lift or move office products and supplies, up to 20 lbs.

Black Diamond Therapeutics is an equal opportunity employer and welcomes and encourages all applications. Diversity and inclusion are important core values and will encourage our creativity and growth as a company. Accommodations are available on request for candidates taking part in all aspects of the selection process. We thank all applicants for their interest, however, only those selected will be invited for an interview.