Associate Director/Director GMP Product QA Contractor

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.

Provide Quality Assurance oversight of the development and registration of drug substances and drug products from starting materials through manufacturing, packaging, labeling, shipment of and distribution of clinical supplies. 

Responsible for providing Quality Assurance oversight of method development, validation, and stability testing for raw materials, intermediates, drug substances as well as pre-clinical, clinical drug products and associated methodology such as impurity analysis, content uniformity, dissolution and stability studies.

Additional support will be provided for service provider oversight through activities such as conducting GMP audits, assessing and updating Quality Agreements and assisting with Supplier Corrective Action Records.  Other related support will be requested from time to time. All services and deliverables will be performed and produced in accordance with GMP, GDP and GCP standards.

• Provide Quality oversight of the development and registration of drug substances and drug products from starting materials through manufacturing, packaging, labeling, shipment of and distribution of clinical supplies.  
• Provide Quality oversight of method development, validation, and stability testing for raw materials, intermediates, drug substances as well as pre-clinical, clinical drug products and associated methodology such as impurity analysis, content uniformity, dissolution, and stability studies.  
• Guiding functional areas in writing/ reviewing of GMP documentation such as change controls, validation reports and methods, ensuring laboratory deviations and atypical results/OOS/OOT/are properly investigated and documented.
• Provide quality support and leadership to the CMC teams to ensure compliance with GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) for product manufacturing, distribution and GCP (Good Clinical Practices) to ensure on-time delivery of safe and compliant product to the clinical sites.
• Activities include but not limited to review and approval of GMP master documentation, production batch records, change controls, labeling specifications (Texts/proofs), SOP’s, GMP release, shipping/distribution to the clinic, approval of Pharmacy manual, and IRT protocols.

• In some situations, this individual will act as person-in-plant at our CMO/CPO’s during primary production and secondary packaging and labeling operations.
• Responsible for managing temperature excursion and product complaints related to packaging and logistics.  
• Responsible for all QP related interactions such as establishing Quality to QP quality agreements, coordinating QP audits, obtaining and delivering documents as required.  
• Works with the Clinical Supply Chain team to ensure on-time commitments for quality oversight and management of all logistics and packaging process related risks, change controls, deviation/investigation, CAPA, batch disposition and product complaints.
• Review and approve Quality documentation, as well as review or collect data for sections of regulatory submissions e.g., IMPD/IND and regulatory filing lifecycle management requirements. Ensure GMP investigations have proper closure and identification of effective corrective actions including product shipping excursion and product quality complaint Investigations, stock-recoveries 
• Review and approval of validation master plans (VMPs), process validation protocols and reports, and engaging internal teams to identify and drive continuous improvement.
• Provide annual product quality review as applicable. 
• Maintain QA Operations logs and control documents.
• Support or manage a supplier quality management program 
• Support or perform internal, supplier due diligence and qualification GMP audits • Contribute to regulatory inspections.
• Monitor quality performance metrics and drive continuous improvements of CMO/CPO processes.  
• Identify, as needed, areas of improving process and procedures in area of responsibility.

• A minimum of a Bachelor’s degree is required. Master’s degree in life sciences preferred.
• A minimum of 10 years of relevant experience in the pharmaceutical, biotechnology industry in Quality Assurance. 
• Direct experience in working with and supporting clinical supply operations.  
• Solid understanding of clinical supply chain and logistics  
• Solid understanding of EU Qualified person requirements
• In depth understanding and knowledge of US, EU, AU, JP and other Asian Countries GMP/GCP product/clinical supplies quality requirements.
• Experience in working with external partners, contract manufacturing/packaging organizations. 
• Relevant quality experience in the clinical product support systems including IRT (or relevant inventory system), Pharmacy manuals, IMP disposition per GMP, GCP and GDP.
• Additional knowledge and hands-on experience in regulatory inspections.
• High level of written and oral communication skills, Presentation skills, use of Microsoft office.
• Must have working knowledge of quality systems as they apply to GMP operations using contract manufacturing of product and to make informed decisions.
• Shall have the ability to be detail- oriented to understand complex issues and possess the skills to problem solve with a sense of urgency.
• Working experience managing a supplier quality management program and experience auditing CMO’s.
• Ability to handle multiple priorities on a daily basis while being flexible and responsive to frequently shifting priorities
• Prior experience working in small or mid-sized biotech is preferred • Proven people management and leadership experience is required
• 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.