Vice President of Quality

Bend, Oregon /
Quality – Quality Assurance /
Full-time Exempt
The Vice President of Quality oversees the combined effort of the Quality Assurance and Quality Control departments.  Required attributes include an innovative, results-driven, and broad-minded quality control and assurance executive with extensive experience in compliance and regulations, systems management, deviations, design and development, project management, strategic planning, training and mentoring, client/vendor relations, performance management, and change management.  Extensive experience with laboratory and manufacturing operations is required.

The successful candidate will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments.

Supervisory Responsibilities

    • Building and leading the Quality Assurance and Quality Control groups
    • Provides constructive and timely performance evaluations
    • Handles discipline and termination of employee in accordance with company policy
    • Performs other related duties as assigned

Duties and Responsibilities

    • Implementation and continuous improvement of the company’s quality systems and facility validation
    • Quality Systems, Deviations, CAPA, EC, Change Control, Document Management, Validation, and Auditing
    • Document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
    • Oversight of investigations
    • Support of internal audits and client audits, as needed
    • Primary host of regulatory inspections
    • Oversight of a broad range of documentation including, but not limited to, User Requirements (URS), Functional and Design Specifications, Testing Protocols (Cx/IQ/OQ/PQ), Change Control, and Risk Assessments
    • Work with cross-functional teams to troubleshoot equipment, process, and validation issues
    • All other duties as assigned

Required Skills and Abilities

    • Broad knowledge FDA and international regulations related to GMP and Pharmaceuticals
    • Experience organizing and managing work responsibilities while working independently with minimal oversight
    • Time and project management skills with the ability to multi-task and meet deadlines
    • Excellent verbal and written communication skills 
    • Excellent interpersonal and customer service skills 
    • Excellent organizational skills and attention to detail
    • Strong analytical and problem-solving skills
    • Strong supervisory and leadership skills
    • Ability to prioritize tasks and to delegate them when appropriate 
    • Proficient with Microsoft Office Suite or related software

Education and Experience

    • Minimum of a bachelor’s degree, preferably in a scientific discipline.  An advanced degree is preferred
    • 15+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
    • Experience with facility validation activities
    • Experience with regulatory inspections by the FDA and EU authorities

Physical Requirements

    • Prolonged periods of sitting at a desk and working on a computer
    • Must be able to lift up to 15 pounds at times