Associate Director, Quality Systems & Operations

Location
San Diego, CA, United States
Posted
Apr 12, 2019
Ref
o1nV8fwb
Required Education
Bachelors Degree
Position Type
Full time
Function/Scope:

The Associate Director, Quality Systems and Operations will establish, maintain, and ensure effectiveness of quality systems and operations to assure compliance in a GxP pertaining to GMP, GLP and GCP as well as relevant ICH, US and EU regulations. This position will have direct influence on the internal systems and external compliance for gene therapy platform products built on retroviral replicating vectors, or RRVs, initially for patients with recurrent high grade glioma (rHGG).

Duties and Responsibilities Include But Are Not Limited To:
  • On behalf of Tocagen, lead and/or represent internal/external manufacturing Quality site management
  • Review and release of clinical and commercial manufacturing batch campaigns for drug substance and drug product (biologics and solid orals) as well as final product packaging
  • Oversee and develop a team of Quality Systems and Operations professionals with varying degrees of experience
  • Support process transfer and process engineering of retroviral replicating vectors (RRV) platform products including process optimization, new product implementation, process transfer, scale-up, validation, risk analysis process characterization and troubleshooting
  • Lead quality management monitoring, annual product reports, and other summary manufacturing data reviews as required to maintain product performance and licensure
  • Direct post-filings, coordinating activities across multiple stakeholders
  • Create and maintain validated process, equipment, and components including single use disposable systems
  • Oversee GxP compliance for all aspects of Tocagen's programs to support clinical studies and future product registration
  • Provide GxP Quality Assurance oversight of all external vendors' quality programs, including CMOs, Contract Testing Vendors, investigator sites, including maintenance of quality agreements
  • Establish & maintain phase-appropriate Quality Management Systems
  • Responsible for deviations, product complaint investigations and GxP archives
  • Ensure the adherence to industry standards and practices when conducting root cause investigations
  • Oversee compliance auditing program to fulfill regulatory requirements
  • Develop effective partnerships with internal staff and external organizations to help formulate and implement proactive regulatory compliance strategies and controls
  • Track, evaluate, and manage production related quality data and leverage to improve product quality
  • Provide core launch team membership to due proactively plan and execute launch readiness activities with compliant quality product supply in a timely manner
  • Ensure Quality Agreements are in place and CMOs are in compliance
  • Oversee PLI, PAI, and CMO biennial inspections as required
  • Provide Quality Assurance input to strategic goals in the form of schedules, plans, and budgets
  • Hire and manage quality function personnel
  • Lead as a change agent in fast-paced environment to promote flexibility, creativity, and accountability to ensure speed to market
  • Create an environment of teamwork, open communication, and sense of urgency
  • Performs other duties as required.


Desired Knowledge and Abilities:
  • Extensive knowledge of development and optimization of biopharmaceutical Quality/Manufacturing validation and commercialization industry standard processes
  • Fundamental knowledge of single-use technologies and suppliers
  • Knowledge about the biotechnology, virus, gene, and/or cell the manufacturing industry landscape, the key companies and their products/processes.
  • Active leader in professional biopharma industry organizations (e.g. PDA, ICH, ASQ, ISPE, USP)
  • Established Quality network across the biopharmaceutical DS/DP outsourcing industry
  • Relevant certification and specialty training a plus (e.g. ASQ, Six Sigma, PM)


Education and Experience:
  • BS in Biology, Microbiology, Chemistry, or a related pharmaceutical science (e.g. Pharmacy). An advanced degree a plus.
  • Proven staff leadership abilities in developing staff and functional integration into multi-disciplinary project teams
  • A minimum of 10+ years of progressive managerial experience within the Quality function of a pharmaceutical company. A minimum of 5 years supervisory experience leading a Quality function is preferred.
  • Experience working in small biopharmaceutical company and/or experience working within a virtual manufacturing company utilizing a number of contract manufacturing organizations is preferred
  • Extensive knowledge and experience in GXP and QA principles, practices & industry standards
  • Experience with biologics development programs, as well as small molecule biologics from early-stage through commercial. Experience with parenteral products is preferred.
  • A strong team player is required with the ability to effectively communicate sound Quality advice cross-functionally based on experience, regulations & business needs
  • Strong negotiation skills, flexibility & ability to provide a solution-based approach to emerging challenges
  • Excellent communication skills and abilities to collaborate with and present to individuals of varying levels of authority, including senior and Executive leadership
  • Excellent verbal and written communication skills; strong presentation skills as this role requires the ability to communicate and connect with all levels of the organization
  • Skilled at acquiring, developing, and qualifying quality electronic management systems (e.g Trackwise, Veeva, LIMS, etc.)