Sr. Director, Head of GMP Quality

Location
Cambridge, MA, US
Posted
Feb 09, 2021
Ref
1081
Discipline
Quality, Quality Control
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.

Black Diamond Therapeutics (BDTX), a clinical stage company, based in Cambridge Massachusetts is seeking an experienced Director/Sr. Director of GMP Quality Operations. The role will be responsible for directing and executing GMP QA activities supporting CMC, API, Drug Product and Supply Chain/Logistics operations for clinical supplies and commercialization. The incumbent will ensure a robust and compliant Vendor management that complies with FDA, global health authority regulations and BDTx procedures. The position will ensure implementation of all elements of a mature and robust QA oversight functions for GMP projects/programs for product quality in compliance with all applicable regulations.

Responsibilities
  • The Sr Director, Head of GMP Quality will collaborate with stakeholders to set GMP QA strategy, and will provide day to day GMP QA support including hands-on functions of GMP contract manufacturing organizations utilized by BDTx.
  • These responsibilities involve working closely with Quality Systems, and the European QPs.
  • Partner with cross-functional teams to ensure products are delivered on time and within specification.
  • Review and approve Quality documentation, as well as review or collection of data for sections of regulatory submissions and IND/NDA lifecycle management requirements.
  • Review and approve master batch records for contract manufacturing organization drug substance, bulk drug product, packaging and clinical labeling operations
  • Perform detailed documentation review of clinical and commercial contract manufacturing executed production records and QC testing results for GMP compliance and according to the approved master records and specifications (API, excipients, drug product, packaging and clinical labeling batches).
  • Determination and accountable for QA product disposition decisions in support of clinical supplies manufactured at CMO sites.
  • Provide Quality support for GMP-related technical transfer activities
  • Review and approval of validation master plans (VMPs), process/method validation protocols and reports, and engaging internal teams to identify and drive continuous improvement.
  • Review and approve GMP change request to ensure the proposed changes are clearly described, justified, and validated or verified as completed per the pre-approved change request.
  • GMP/QA review of QC stability and test method protocols and reports.
  • Perform technical assessments and QA approval of deviations, investigations, and corrective actions.
  • Ensure GMP investigations have proper closure and identification of effective corrective actions.
  • Review and/or approve select standard operating procedures and other controlled GMP documents as necessary.
  • Perform product Complaint Investigations, stock-recoveries and provide annual product quality review as applicable.
  • Communicate/collaborate with internal Subject Matter Experts and contract manufacturing organizations on quality related issues supporting BDTx QA. Maintain QA Operations logs and control documents.
  • Support or perform internal, supplier and qualification GMP audits
  • Contribute to regulatory inspections.

Qualifications
  • A minimum of a Bachelor's Degree is required. Master's degree in life sciences preferred.
  • A minimum of 15 years of relevant experience in the pharmaceutical, biotechnology industry.
  • High level of expertise in GMP compliance to be decisive and be able to educate peers and colleagues at the same time with experience in solid dosage forms and API.
  • 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.
  • Work in a collaborative team setting with cross functional teams in Technical operations and Supply chain/Clinical supplies operations.
  • Knowledge of cGMP regulations 21CFT parts 210/211, ICH and FDA/EU guidance.
  • 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.