Responsible for the establishment, coordination and supervision of the Company's Quality Assurance function including policies, objectives, plans, procedures and audits.  Ensures the quality of the Company's products and services meet the requirements, specifications and quality standards established by the Company, the Company's clients, and regulatory agencies.  Provide updates to Senior Management regarding routine and risk outcomes through the generation of quality metrics.

 Job Description:

 ·        Provide overall GxP Quality Assurance (QA) leadership and strategic development for GxP Quality Assurance activities, to ensure collaborative team involvement and implementation of quality and compliance activities.

·        Establish and manage a corporate wide Quality Management System (QMS) and maintain such policies, standards and plans to ensure regulatory agency compliance. Ensure consistent alignment in support of the corporate quality standards and corporate policies and standard operating procedures.

·        Develop and implement GxP quality strategies for clinical studies and Company’s marketed product(s), including establishment and maintenance of phase appropriate quality systems, proactively identifying, and mitigating quality risks. Develop and oversee quality metrics and reporting, to ensure Company’s quality goals, objectives and standards are adhered to.

·        Review regulatory and corporate compliance risks, alerting Senior Management when necessary.

·        Interface with key stakeholders including Commercial/Marketing, Research and Development (R&D), Clinical Operations, Regulatory and Manufacturing to establish quality requirements for individual products and projects to ensure quality standards and regulatory agency requirements are met.

·        Manage the quality audit program. This includes the review and approval of audit plans, conduct quality internal audits and test functions and systems to ensure that proposed and existing products and processes quality standards are maintained. Assess potential vendor/supplier quality practices and suitability for use. Audit vendors/suppliers/sites in support of Company programs or acquisitions.

·        Host and manage regulatory agency inspections and licensing business partner audits.

·        Train personnel on regulatory inspection processes, assist the R&D and Pharmacovigilance business with inspection responses and maintain inspection readiness.

·        Communicate significant quality risks that may impact product suitability or regulatory compliance to Senior Management.

·        Oversee quality incident investigations, including input and approval of plans for resolution of quality issues, partnering with internal and external stakeholders to ensure CAPAs are appropriate and effective.

·        Manage and develop Quality Assurance personnel, including recruitment, performance management, hiring, training and development.

 Job Requirements:

·        Educational: Applicable Medical, Healthcare or Biological Sciences degree required.  Advance degree strongly preferred or combination of education and related work experience.

·        Experience: 15+ years of GXP experience.

·        Skills: Effective communications, both oral and written; experience in reviewing sensitive documents; ability to defend critical audit observations; ability to train staff in accordance with regulatory and company standards; good working knowledge of, and ability to train others on FDA, EMEA, MHRA, PMDA and Health Canada regulations, and ICH

·        Travel: Approximately 20 - 30% domestic and international