Quality Assurance Validation Manager

Bend, Oregon /
Quality – Quality Assurance /
Full-time Exempt
/ On-site
There’s a science to success.  At Serán BioScience our team of seasoned scientists use their expertise and data-based methodology to customize novel pharmaceutical development and delivery. Serán seeks curious and collaborative individuals to join our efforts to help solve the industries toughest drug product problems.  Want to have a global impact while being seen for your individual contributions? Imagine yourself in this valuable role within the Quality Assurance team. The primary role of the QA Validation Manager is to ensure compliance of regulation on processes for qualifying on topics such as computerized systems (CS), process and laboratory equipment’s, facilities, and utilities in line with cGMP requirements, data integrity, GxP regulations, international and company standards. This individual will provide expertise to Qualification/Validation teams. Responsibilities include defend company's interest regarding Qualification/Validation and ensure they are anticipated in the company.

Supervisory Responsibilities

    • Qualification/Validation quality representative in project team to support validation of enterprise computer systems
    • Help to schedule and forecast validation / qualification activities
    • Train testers before testing execution and review the executed testing
    • Train and support groups and external contractors involved in Validation/Qualification activities
    • Review and approve validation documentation (VP, protocols, reports…) for CS and authorize the release of CS systems
    • Review and approve documentation for infrastructure qualification
    • QA representative in IT change management process to ensure GMP changes are under control and compliant to regulations
    • Take part in writing or reviewing policies, approaches, technical guidance and document templates for validation, periodic review, continuous improvement (advisor) and revalidation the different types of systems and equipment in line with various guidelines (Eudralex Volume 4 (Good Manufacturing Practices) part I and part II and associated Annexes, 21CFR part 11, 21CFR part 210&211 (cGMP), ICHQ7 (cGMP for API), ISPE guidelines, GAMP5)
    • Computerized systems
    • Manufacturing process
    • Data integrity management
    • Support the sites for establishment and implementation of their QMS program based on risk, compliance, and efficiency for the group from a quality compliance perspective
    • Support GMP sites to develop and maintain data integrity compliance
    • Contributes actively to the upgrade of documents related to computerized system compliance assessment and validation
    • Provide expertise to be compliant with 21CFR part 11 and data integrity regulatory guidance
    • Involved in site audits as expert auditor on Validation/Qualification
    • Support audit/inspection readiness and assist in responding to regulatory audits for Qualification/Validation topics
    • Attend sector groups on Qualification/Validation to remain up-to-date with the latest requirements (e.g. ISPE) and defend company's interest

Duties and Responsibilities

    • Approval of validation programs to support projects for new product introduction, tech transfer, product / process optimization in the Commercial Manufacturing facility
    • Manage the validation programs in conformance with all applicable guidelines, policies, procedures, and requirements
    • Review and approve validation protocols and reports
    • Coordinate training and execution of validation studies
    • Work with internal and external teams to enhance current Quality and Technical systems supporting product development projects transitioning from Phase 3 clinical to registration as part of technology transfer, and using Product Lifecycle concepts
    • Other related duties as assigned

Required Skills and Abilities

    • Knowledge of cGMPs and Global Regulatory (E.g., FDA / MHRA / EMEA) guidelines and regulations acquired through education, experience, and training
    • Knowledge on Regulatory expectations and Industry practices for Validation using Product Lifecycle approach
    • Effective written, oral, and interpersonal communication skills
    • Excellent leadership skills with ability to motivate and coach employees
    • Strong time-management skills and the ability to organize and coordinate multiple projects at once
    • Proficiency in enterprise systems, Microsoft Office and other office productivity tools, with aptitude to learn new software and systems

Education and Experience

    • Master or bachelor’s degree in a scientific discipline or another discipline with equivalent experience and training
    • A minimum of 5 or more years’ experience as QA/QV developing and executing equipment qualification, process, cleaning, computerized systems validation projects in a Quality Assurance or Technical Services capacity
    • Five or more years of experience in pharmaceutical process development and/or technology transfer, commercial manufacturing and scale-up of approved products
    • Strong background and knowledge of the following: cleaning validation regulations and requirements (US and EU) for both API and finished pharmaceutical products, Health authority expectations

Physical Requirements

    • Prolonged periods of sitting at a desk and working on a computer
    • Prolonged periods of sitting or standing in a manufacturing environment
    • Must be able to lift to fifteen pounds at times