Director SQA/RA

The Director of Quality and Regulatory will report directly the CEO of CRF Inc.  The Director will be tasked with evolving an existing quality assurance group into an enterprise class Quality organization.  Our Quality Assurance Engineers must collaborate throughout the product life cycle with software developers, usability experts, project managers, software testers and other professionals to engineer and deliver a quality product to CRF Inc.’s global pharmaceutical customers. ResponsibilitiesDevelop quality engineering processes to the next stage, define and track appropriate quality release/exit criteria, and lead efforts to ensure that all products are released with levels of quality that exceed customer expectations.  Must be a hands-on Quality Engineer with the ability to contribute Build and mentor a strong team of hands-on engineers focused on the latest automation techniques.  Develop partnerships with other functional areas including Development, Applications Support, Customer Support and End Users.  Create and nurture a climate for technical innovation. Promote a vision for the quality engineering team that transcends traditional testing, applying state-of-the-art concepts of product modeling, test automation and SQA to efficiently and effectively carry out tasks.   Develop, build and maintain quality systems, review and assist in authoring SOPS, develop and implement training programs.  Take an active role in simplifying the procedures whilst maintaining regulatory compliance.   Introduce statistical tools, Training information management system, Quality Management System modules (software), Document management systems (software), etc .  Primary Areas of ExpertiseGXP Possess thorough knowledge of GCP and regulations like FDA, EU Directives, ICH  - expert with applicable regulations, for example 21 CFR § 11.   Participated is regulatory inspections, e.g., FDAAudit Demonstrated expertise conducting client audits including pre-qualification and for-cause audit activities Participated in regulatory inspections, e.g., FDA Trained and qualified auditor  Skills Ability to consult and guide teams tasked with delivering validated systems to the clients Significant experience with enterprise software and the entire product lifecycle, from inception through delivery, maintenance and end-of-life.  In-depth experience in testing enterprise software solutions.  Experience in testing software products is necessary. Deep understanding of automated test methodologies, tools and techniques,    and practical application of test automation in major development efforts is required.  Experience defining and using metrics to improve all facets of product quality. Strong issue recognition capability Focus on problem solving Knowledge of root cause analysis techniques Positive “can do” attitude Knowledge of ISO software quality standards, principles & methodologies  ISO 9001:2000, ISO 12207, ISO 17799, Ability to work independently. Solid understanding on the pharmaceutical industry and GCP clinical trial process Willing to periodically travel to other company, customer, and subcontractor  sites to perform said duties Excellent written and verbal communication skills.  5+ years of experience managing quality engineers.  Experience in building strong teams with an emphasis on teamwork and successful collaboration  Partner with other members of the engineering management team to ensure timely delivery of innovative products Strong leadership and personal characteristics required as site management of Lansdale, PA location will also be a part of this individual’s responsibilities. Education Minimum, Bachelor of Science    Trained Quality Auditor