Director, Quality Engineering & Computer System Assurance

Serán BioScience seeks a Director, Quality Engineering & Computer System Assurance (CSA) to oversee and provide strategic and operational leadership for the organization’s validation, qualification, and computerized systems assurance programs. This role will support GMP manufacturing, laboratory, and quality systems that stretch across clinical and commercial operations.This position is responsible for establishing and maintaining a risk-based validation and CSA framework ensuring that facilities, utilities, equipment, analytical methods, processes, and computerized systems remain in a validated state throughout their lifecycle. The Director, Quality Engineering & CSA ensures all validation and data integrity activities comply with FDA, EU, and international regulatory requirements, including cGMP, GAMP guidance, and current regulatory expectations for data integrity.The role partners with Engineering, Manufacturing, Quality Control, IT, Regulatory Affairs, and Technical Operations to ensure validated systems and processes enable safe, compliant, and reliable manufacturing of clinical and commercial products. The Director, Quality Engineering & CSA also serves as a key Quality leader during regulatory inspections, client audits, and internal quality reviews, and drives continuous improvement initiatives related to validation lifecycle management, computerized system assurance, and data governance.Duties And ResponsibilitiesStrategic LeadershipDevelops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programsSupports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic reviewLeads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle managementDefines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programsProvides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitieValidation Lifecycle Oversight Provides Quality leadership and oversight of validation programs including:Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systemsKey activities include: Approval and oversight of validation lifecycle documentation including:Validation Master Plans (VMP), User Requirement Specifications (URS), Functional and Design Specifications, Risk assessments, IQ/OQ/PQ protocols and reports, & Validation summary reportsEnsures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master PlanProvides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environmentsEnsures validated systems maintain a continuous state of control throughout their operational lifecycleComputer System Assurance (CSA) & Data Integrity Supports the design and implementation of the organization’s Computer System Assurance (CSA) and Computerized System Validation (CSV) programsEnsures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectationsOversees validation lifecycle management for computerized systems including:Manufacturing Execution Systems (MES), Laboratory Information Management Systems (LIMS), Quality management systems, Electronic Batch Record Systems, & Enterprise resource planning systemsImplements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologiesLeads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systemsSupports system lifecycle activities including system upgrades, migrations, and decommissioningOperational Quality Engineering Support Provides QA oversight and approval for quality system elements impacting validated systems including:Change control processes impacting validated systems and processes, Deviation and investigation management, Corrective and Preventive Actions (CAPA), Risk management and impact assessments, & Periodic reviews of validated systemsEnsures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standardsProvides QA support for technology transfer, new product introductions, and site capital projectsServes as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologiesSupports troubleshooting of complex process or system issues impacting validated systemsServe as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client auditsLeads preparation and inspection readiness programs related to validation and data integrityLeadership & People ManagementLeads and develops a high-performing Quality Engineering and CSA organizationProvides mentoring, coaching, and professional development for technical staffEstablish clear departmental goals aligned with organizational quality and operational objectivesConducts performance reviews and ensure staff maintain appropriate training and GMP qualificationsFosters a culture of quality ownership, compliance, and continuous improvementRequired Knowledge And SkillsBroad knowledge of FDA and international regulations related to GMPs and PharmaceuticalsExperience organizing and managing work responsibilities while working independently with minimal oversightDeep expertise in Computer System Validation / Computer System AssuranceValidation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologiesTime and project management skills with the ability to multi-task and meet deadlinesExcellent verbal and written communication skillsExcellent interpersonal and customer service skillsExcellent organizational skills and attention to detailStrong analytical and problem-solving skillsStrong supervisory and leadership skillsAbility to prioritize tasks and to delegate them when appropriateWillingness to accept feedback from a variety of sourcesAbility to constructively manage conflictAbility to collaborate and work in cross-functional teamsAbility to function well in a high-paced and at times stressful environmentAbility to maintain productive relationships with coworkers, clients, and other contacts outside the companyProficient with Microsoft Office Suite or related softwareEducation And ExperienceBachelor’s degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree Minimum of 10+ years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industryMinimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacityDemonstrated experience with regulatory inspections by the FDA and EU authoritiesPhysical RequirementsProlonged periods of sitting or standing at a desk and working on a computerMust be able to lift up to 15 pounds at timesAdheres to consistent and predictable in-person attendance Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.Benefits Summary:Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees’ wellbeing, along with access to pet insurance.The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.