VP - Head of Quality Assurance

Location
Cambridge, MA, US
Posted
Aug 23, 2020
Ref
1035
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Overview

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

The VP - Head of Quality Assurance is responsible for the strengthening and further development and execution of the Company's quality assurance program and systems, in support of all drug development and manufacturing activities, directing cGxP quality related activities across the organization to support global regulatory submissions (NDA/MAA, etc) and ultimately commercial launch of products. The VP will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters. This position requires expertise in current Good Manufacturing Processes (GMP), Good Clinical Practices (GCP), Good Pharmacovigilance Practices (GVP), and Good Laboratory Practices (GLP) and relevant regulations.

Responsibilities
  • Ensure that our Quality System meets standards expected by US and global regulatory authorities for research, development and ultimately commercial activities.
  • Ensure quality metrics comply with best industry standards and practices.
  • Maintain an effective Quality governance and continually improve governance to meet business and compliance needs.
  • Determine applicable quality standards and regulations and provide guidance and quality oversight to ensure ongoing compliance.
  • Ensure products manufactured at CDMOs meet company quality standards and government regulations.
  • Counsel, train and interpret quality requirements to ensure we and our GxP vendors maintain a state of compliance.
  • Communicate significant quality risks that may impact product suitability or regulatory compliance in a timely manner to Executive Management.
  • Continually establish and improve quality systems, initiatives, priorities and timelines.
  • Establish strong working relationships with external manufacturers of our products and assure alignment of our Quality Systems and requirements with these CDMOs.
  • Serve as an escalation point for corporate quality issues.
  • Responsible for supplier/vendor qualification audit and inspection management.
  • Serve as primary contact in any audit by a regulatory authority and lead all audit communications with audit personnel from a regulatory agency.
  • Conduct all duties in compliance with country specific regulations, applicable SOPs, and other applicable guidelines.

Qualifications
  • Bachelor's degree or Master's degree in related Life Sciences discipline. Equivalent combination of education and applicable job experience may be considered.
  • 15+ years of relevant experience in GxP, QA management or QA leadership positions in a Biotech or Pharmaceutical industry.

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.