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    Sr Director/Director, Quality Systems

    Clinovo
    15+ years
    $197.5-$226K
    Seattle Washington
    10 Jan. 23, 2025
    Job Description
    Job Type: Full Time Education: B.Sc,M.Sc,B.Pharma,M.Pharma,LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Senior Director/Director, Quality Systems
    Location: Seattle, Washington
    Employment Type: Permanent
    Compensation: Base Salary Range: $197.5K - $226K (Depending on experience and title)

    Position Overview:

    The Senior Director/Director of Quality Systems will be responsible for leading the development, implementation, and maintenance of a robust Quality Management System (QMS) that ensures compliance with Good Manufacturing Practices (GMP) and other regulatory requirements. This leadership position involves collaborating with both internal and external stakeholders to ensure product quality and regulatory compliance throughout the entire product lifecycle, from development to commercialization.

    Key Responsibilities:

    Quality Management:

    • Lead the development and execution of a strategic vision for the Quality Management System (QMS), aligning it with the company’s long-term business objectives.
    • Oversee the implementation and maintenance of quality systems that ensure compliance with global regulatory standards, including FDA, EMA, ICH, etc.
    • Ensure effective management of CAPA (Corrective and Preventive Actions), change controls, deviations, and other GMP-related processes.
    • Lead continuous improvement initiatives within the QMS, focusing on efficiency, effectiveness, and compliance with all applicable GMP regulations.
    • Oversee the revision of SOPs, policies, and Quality Agreements to stay aligned with regulatory updates and business needs.
    • Ensure training programs related to GMP, GCP, and other quality standards are effectively developed and executed.

    Documentation and Record Control:

    • Manage GxP document control and records management systems, ensuring proper approval, archiving, and retrieval processes.
    • Serve as the business process owner for the company’s electronic document management system (EDMS), ensuring system validation and continuous improvement.
    • Implement and oversee the Computer System Quality Assurance and Data Integrity programs for electronic-based systems in compliance with 21 CFR Part 11.

    Regulatory Compliance and Inspection Readiness:

    • Ensure the organization’s quality systems remain inspection-ready and in compliance with regulatory requirements for GMP audits or inspections.
    • Collaborate with regulatory affairs and cross-functional teams to support regulatory submissions, including providing necessary documentation and ensuring compliance.
    • Support site preparation for regulatory inspections, including training and personnel preparation.
    • Manage the storage and organization of Quality Agreements, ensuring proper record keeping.

    Operational Leadership and Continuous Improvement:

    • Lead continuous improvement initiatives across quality operations, focusing on operational efficiency, risk reduction, and product quality enhancement.
    • Provide strategic leadership and direction to quality operations teams, ensuring alignment with business goals and regulatory demands.
    • Develop metrics to monitor and report on the performance of quality operations, ensuring that corrective actions are taken when necessary.
    • Promote a strong Quality culture within the organization, identifying compliance risks and collaborating on solutions.

    Team Leadership and Development:

    • Mentor, coach, and develop a high-performing quality team to support organizational growth.
    • Set performance objectives for direct reports and manage their development through regular evaluations and feedback.

    Qualifications:

    Education and Experience:

    • Bachelor’s degree in life sciences, chemistry, engineering, or related field; advanced degree (MS, PhD, MBA) preferred.
    • Minimum of 15 years of experience in quality assurance, quality systems, and/or quality operations within the pharmaceutical, biotechnology, or life sciences industries.
    • At least 5 years of leadership experience in quality systems management.

    Skills and Competencies:

    • Proven experience managing GMP operations, QMS, and vendor management, including oversight of CMOs.
    • Deep knowledge of global regulatory guidelines (FDA, EMA, ICH) and their application to Quality Operations.
    • Experience supporting both clinical and commercial stage programs, with a strong understanding of the product lifecycle.
    • Strong leadership, project management, and organizational skills with the ability to multitask and prioritize in a fast-paced environment.
    • Excellent verbal and written communication skills, with the ability to collaborate effectively across functions and at all organizational levels.
    • Demonstrated ability to lead cross-functional teams and manage external vendors and stakeholders.
    • Proficiency in using electronic QMS platforms (e.g., MasterControl, TrackWise, Dot Compliance) and Microsoft Office Suite (Word, Excel, PowerPoint).
    • Strong strategic thinking and a proactive approach to problem-solving and process improvement.

    Compensation:

    • Base Salary: $197.5K - $226K, depending on experience and title.

    How to Apply:

    Interested candidates should submit an updated resume that highlights relevant experience and qualifications.

    Clinovo is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind

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