Associate Director, Quality Control

San Diego, CA

  • We are seeking a responsible, dynamic, creative and highly motivated Associate Director to join our Quality Control Unit. 
  • The Associate Director of Quality Control is responsible for designing, planning, implementing, and evaluating a Quality Control function which supports  analytical development and regulatory approval of products.
  • This role requires extensive interaction with CMC, Regulatory Affairs, and vendors.
  • This is a full-time position in the company’s San Diego headquarters.

Specific Responsibilities

  • Develop, implement, maintain and continually assess a quality control function and a quality management system for applicable regulated activities to meet internal company standards and external regulatory requirements.
  • Plan and coordinate all the quality control activities.
  • Review and approve release and stability specifications and COAs for reference standards, raw materials, drug substances and drug products.
  • Manage method development and method validation activities for drug substance, drug substance intermediates and finished drug products.
  • Review stability study design, monitoring, reporting and data trend-analysis.
  • Manage method transfer activities to contract manufacturing organizations/testing laboratories.
  • Review/approve, methods, protocols, validation reports etc.
  • Write/review/approve deviations and investigations.
  • Establish and maintain QC procedures, work instructions and forms
  • Contribute to Annual Product Reviews.
  • Perform GxP vendor audits as necessary to establish or maintain regulatory and Biosplice compliance
  • Review analytical sections of CMC for regulatory submissions and annual reports
  • Implementing, performing and overseeing  quality auditing of QC function-including applicable vendors or subcontractors,  audit response, and other QC related quality management system activities.
  • Review and recommend appropriate corrective action to ensure consistency with the quality control function and the quality management system.
  • Develop, revise and review procedures and other controlled documents
  • Perform other duties as necessary

Requirements

  • B.A. or B.S. degree or equivalent experience in a scientific or related discipline Advanced ability to define problems, collect data, establish facts, and draw valid conclusions
  • Ability to successfully manage a full workload across multiple-projects
  • Ability to manage vendor compliance
  • A flexible attitude with respect to work assignments and continued industry related education
  • Must have ability to innovate, think strategically and conceptually, and manage multiple projects simultaneously
  • Ability to handle even difficult situations professionally and maintain a professional and caring
  • demeanor
  • 8 or more years of relevant experience in a Pharmaceutical, Biotech or CRO environment is ideal
  • Strong GxP and regulatory knowledge including FDA and ICH regulations
  • Proven ability to collaborate in a team environment and work independently
  • Excellent oral and written communication skills
  • Must be a team-player, punctual and reliable, dependable and flexible in adapting to change in a multi-disciplinary, fast-paced work environment

Please submit your resume or additional inquiries to apply@biosplice.com. Please include the complete title of the position for which you are applying in the subject line of your email. Emails that do not include this information will be disregarded. NO PHONE CALLS PLEASE.