Careers

Director/Senior Director – Quality

Location: Berkeley, CA – USA

Reports Into: Senior Vice President, CMC

Summary & Scope of Position:

Direct, manage, develop and implement Quality Assurance and Quality Control (QA/QC) programs for compliance with applicable national and international regulations (such as US-FDA, and numerous rest of world (ROW) regulatory bodies), standards, internal Standard Operating Procedures (SOPs) and best industry practices to ensure that Company products comply and meet applicable regulatory requirements. The Quality team is extensive and demands both hands-on supervisory skills and leadership.

Primary Responsibilities:

  • Oversee quality assurance (QA) activities related to FDA and ROW regulations for biologics, cell therapeutics and chemical synthesis clinical and/or commercial Active Pharmaceutical Ingredients (API), Drug Substances (DS) and Drug Products (DP).
  • Lead a team of Quality professionals to enhance performance and maintain accountability for the implementation of QA systems
  • Create, implement and maintain key QA systems, including creation/revision/review of internal SOPs and other quality documentation, including investigation reports (OOS, Deviation. CAPA, etc.), audit reports, protocols, interim reports and final reports (including process and method validations, non-clinical studies, etc.)
  • Report significant investigation/deviation issues and system deficiencies to senior management, as appropriate
  • Manage internal document control system, including development of document templates and forms, and coordinate report generation from preclinical/research/product development/stability studies
  • Perform internal and external (Contract Manufacturing Organizations (CMO) and Contract Testing Labs (CTL) quality audits and facilitate corrective actions
  • Manage internal training program and coordinate and/or administer GxP (including GMP, GCP and GLP) training, as needed
  • Review and/or approve manufacturing- and Quality Control-related documentation (internal and external), including unexecuted batch record (BR) approval and executed BR review/approval, Aduro final lot release for intermediates (API/DS), final drug product and clinical/commercial labeling, external Aduro product-specific specifications, method and process procedures and stability testing data
  • Review and verify integrity of raw data, where applicable, and approve protocols, interim, and final study reports
  • Facilitate the maintenance of equipment/facility calibration/PM files
  • Assure product integrity through the cold chain storage and shipments
  • Manage and maintain the CMO/CTL quality relationships, along with routine vendor qualification per SOPs
  • Prepare and approve Quality Agreements and provide input for Supply Agreements
  • Prepare and review relevant CMC sections for regulatory filings
  • Ensure budgets, schedules, resourcing, performance and safety requirements are met as applicable for QA function
  • Identify/implement new applicable state/local/federal/ROW regulations and standards that apply to QA/QC activities at Aduro       
  • Provide quality and compliance leadership across the organization
  • Identify and perform other related duties as required (includes projects in the areas of compliance and quality systems)
  • As necessary, supervise and/or provide QA/QC guidance to other development and/or scientific staff

Qualifications/Requirements/Skills:

  • Bachelor’s degree in a scientific discipline or equivalent with a minimum combination of 8-12 years relevant QA/QC experience in pharmaceutical and/or biotechnology companies
  • Broad-based industry regulations/standards knowledge and current understanding of quality trends and intents
  • Phase appropriate judgment and experience in drug development
  • Proven leadership skills in Quality management
  • Experience with biologics, recombinant vectors and chemical-synthesized products a plus preferably in the vaccines and/or therapeutic vaccines/immunotherapy space
  • Strong communication (verbal, written, listening); interpersonal skills and ability to communicate across multiple disciplines successfully and accurately (internally and externally)
  • Proficient in writing SOPs, reports and comprehensive quality documentation
  • Experience reviewing technical documentation and reports
  • Proficient in Microsoft Word, Visio, Excel and Adobe Acrobat
  • Time management (timelines, schedules, task prioritization) and the ability to work independently
  • Attention to detail and accuracy
  • Ability to grow and integrate the needs of the quality organization
  • Flexible; ability to adapt to changing priorities
  • Able to understand scientific, medical and manufacturing disciplines
  • Familiarity with statistical tools and concepts and their application in a regulated environment
  • In-depth knowledge of multiple biologic/chemical manufacturing processes (including aseptic processing) is desirable
  • Regulatory experience considered a plus

Aduro Biotech, Inc. is at the forefront of discovery, development and commercialization of breakthrough immunotherapies. We provide a workplace where employees excel, thrive and deliver value to patients, their families and our partners. Aduro headquarter office is located in Berkeley, California and international office located in Oss, The Netherlands.

Aduro Biotech, Inc. offers a competitive salary and benefits package. Qualified candidates should forward a resume and cover letter including a statement of interest, availability, and experience in Word or PDF format to: careers@aduro.com  PLEASE, NO PHONE CALLS.

Aduro Biotech, Inc. is an Equal Opportunity Employer