Sr. Director, Quality Assurance/Quality Control

San Diego, CA, United States
May 12, 2019
Required Education
Bachelors Degree
Position Type
Full time

Within a pre-commercial biopharmaceutical company environment, the Senior Director Quality Assurance and Quality Control is responsible for leadership and direction of all aspects of the QA/QC functions, ensuring an appropriate level of compliance of the company's clinical and anticipated commercial production materials. The successful candidate will lead a staff in the release, surveillance, and control of GMP materials as well as enact quality plans and policies while providing progress updates to executive leaders. The position is responsible for the development of commercial Quality Management Systems (QMS) in anticipation of commercial operations and product distribution including Quality leadership oversight of a virtual manufacturing operation consisting of multiple contract manufacturing & laboratory organizations. The individual will design, implement and maintain QA/QC operational systems, compliance programs, and infrastructure - including an SOP system and training program - and perform internal and external audits.

The Senior Director QA/QC will establish, maintain, and ensure effectiveness of quality programs and documentation 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 build and management of contract manufacturing outsourcing supply strategy 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 and timely delivery of clinical and commercial manufacturing batch campaigns for drug substance and drug product (sterile and solid orals) as well as finish packaging
  • Lead, manage, mentor and develop a team of QA/QC 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
  • Establish KPIs, necessary metrics, and reports to support process and Quality performance improvement strategies
  • Lead quality management monitoring, annual product reports, and other summary manufacturing data reviews as required to maintain product performance and licensure
  • Drive forward key activities of post-filings, coordinating activities across multiple stakeholders, removing hurdles, and ensuring decisions are made in a timely manner
  • Create and maintain validated process, equipment, and components including single use disposable systems
  • Design and maintain Quality Assurance and 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, CLOs, central labs, investigator sites, CMSOs, and other key partners supporting clinical programs, including maintenance of quality agreements
  • Write, review, approve and maintain Standard Operating Procedures
  • 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
  • and associated risk assessment of product quality and/or manufacturing systems
  • Ensure training programs throughout Tocagen meet GxP and ICH requirements
  • Direct development and implementation of quality systems to ensure product reliability, quality, efficacy, compliance to applicable SOPs, GxP regulations and applicable country specific standards
  • Oversee compliance auditing program to fulfill regulatory requirements
  • Provide expertise and guidance to Tocagen departments in interpreting and implementing governmental and agency guidelines to assure compliance
  • Follow applicable regulations, including FDA, ICH, GxP, and Tocagen policies and procedures
  • 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
  • Lead qualification, monitoring, and quality oversight of CMO, CLO, and GMP material suppliers
  • Lead and oversee QMR, MRB, APR, and CMO quality reviews and site monitoring audits
  • 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
  • Lead and/or support for PLI, PAI, and CMO biennial inspections as require
  • 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 15+ years of progressive managerial experience within the Quality function of a pharmaceutical company. A minimum of 8 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
  • Experience with using risk-based principles, industry practices, and decision making to ensure compliance at all stages of development
  • Proven track-record of leadership & building relationships with both internal & external customers
  • 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
  • Strong analytical, problem-solving, and critical thinking skills
  • Excellent writing and skills with Microsoft Word, Excel, Power Point, and Project
  • Experience with development and/or commercialization of solid orals a plus
  • Experience managing complex outsourcing manufacturing relationships a plus
  • Interpersonal skills; good judgment and ethics; professional presence and demeanor
  • Strong business orientation and financial skills
  • 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
  • Proven track record of successfully managing escalated compliance events (e.g., enforcement actions, recalls, etc.).
  • Skilled at acquiring, developing, and qualifying quality electronic management systems (e.g Trackwise, Veeva, LIMS, etc.)
  • Skilled in Six Sigma tools, Project Management, and Risk Management methodologies
  • Availability to travel (~20%)