Director, Quality Engineering & Computer System Assurance

Job description

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 Responsibilities **Strategic Leadership** - Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs - Supports the establishment governance structures for risk-based validation lifecycle management including planning, execution, maintenance, and periodic review - Leads initiatives to modernize validation practices including CSA adoption, digital validation approaches, and automation lifecycle management - Defines key performance indicators (KPIs) and metrics to measure effectiveness of QualityEngineering and CSA programs - Provides leadership to cross-functional teams supporting validation, qualification, and system lifecycle activitie **Validation Lifecycle Oversight** - Provides Quality leadership and oversight of validation programs including: - Facility, utility, and equipment qualification, Cleaning validation, Computerized systems validation / assurance, & Manufacturing automation systems Key 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 reports - Ensures validation activities comply with internal procedures and regulatory requirements and remain aligned with the site Validation Master Plan - Provides quality oversight for commissioning, qualification, and validation activities in highly automated manufacturing environments - Ensures validated systems maintain a continuous state of control throughout their operational lifecycle **Computer System Assurance (CSA) & Data Integrity** - Supports the design and implementation of the organization’s Computer System Assurance (CSA) and Computerized System Validation (CSV) programs - Ensures computerized systems comply with data integrity principles (ALCOA++) and regulatory expectations - Oversees 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 systems - Implements risk-based testing approaches consistent with GAMP 5 and modern CSA methodologies - Leads initiatives to strengthen enterprise data integrity governance programs across manufacturing, laboratory, and quality systems - Supports system lifecycle activities including system upgrades, migrations, and decommissioning **Operational 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 systems - Ensures that validation and CSA programs remain aligned with corporate policies, regulatory guidance, and evolving industry standards - Provides QA support for technology transfer, new product introductions, and site capital projects - Serves as the Quality Engineering representative for site project teams implementing new equipment, systems, or manufacturing technologies - Supports troubleshooting of complex process or system issues impacting validated systems - Serve as subject matter expert for validation, computerized systems assurance, and data integrity during regulatory inspections and Client audits - Leads preparation and inspection readiness programs related to validation and data integrity **Leadership & People Management** - Leads and develops a high-performing Quality Engineering and CSA organization - Provides mentoring, coaching, and professional development for technical staff - Establish clear departmental goals aligned with organizational quality and operational objectives - Conducts performance reviews and ensure staff maintain appropriate training and GMP qualifications - Fosters a culture of quality ownership, compliance, and continuous improvement ### Required Knowledge and Skills - Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals - Experience organizing and managing work responsibilities while working independently with minimal oversight - Deep expertise in Computer System Validation / Computer System Assurance - Validation lifecycle management, Data integrity regulations and industry guidance, Risk-based validation methodologies - 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 - Willingness to accept feedback from a variety of sources - Ability to constructively manage conflict - Ability to collaborate and work in cross-functional teams - Ability to function well in a high-paced and at times stressful environment - Ability to maintain productive relationships with coworkers, clients, and other contacts outside the company - Proficient with Microsoft Office Suite or related software ### Education and Experience - Bachelor’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 industry - Minimum of 5+ years previous experience with qualification/validation/CSA activities in a QA or Technical capacity - Demonstrated experience with regulatory inspections by the FDA and EU authorities ### Physical Requirements - Prolonged periods of sitting or standing at a desk and working on a computer - Must be able to lift up to 15 pounds at times - Adheres to consistent and predictable in-person attendance