Quality Assurance Manager

Bend, Oregon /
Quality – Quality Assurance /
Full-time Exempt
The QA Manager oversees the day-to-day operations of the Quality Assurance department.  Required attributes include a results-driven and broad-minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management.  Experience with laboratory or manufacturing operations is desired. 

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

    • Leads and mentors Quality Assurance personnel  
    • Provides constructive and timely performance evaluations 
    • Handles discipline of employee in accordance with company policy 
    • Performs other related duties as assigned 

Duties and Responsibilities

    • Management and scheduling of department operations 
    • Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, 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 
    • Support of internal audits, client audits and regulatory inspections, as needed 
    • Oversight of a broad range of documentation including, but not limited to User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Control, and Risk Assessments 
    • Work with cross-functional teams to troubleshoot equipment, process, testing, and validation issues 
    • All other duties as assigned 

Required Skills and Abilities

    • Broad knowledge FDA and international regulations related to GMPs 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. 
    • 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry 
    • Experience with regulatory inspections by the FDA and EU authorities is desired 

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