What are the responsibilities and job description for the Associate Director, Quality Engineering & Computer System Assurance position at Serán BioScience?
Company Description Serán BioScience provides optimized drug development and manufacturing services that support clients from discovery through clinical stages. The organization uses a science-driven approach, integrating predictive design tools, novel chemistry, advanced analytics, enabling delivery technologies, and deep quality and regulatory expertise to address complex development needs. Serán’s team specializes in delivery of poorly soluble compounds for both small and large molecules, leveraging technologies such as complex granulations, spray-dried dispersions, hot melt extrudates, and a range of tablet and multiparticulate formats. Custom-built spray dryers support sophisticated particle engineering, from nano-structures to micro-particulates, which are combined with solid dosage expertise to produce high-quality clinical trial materials including suspensions, capsules, and tablets. Team members collaborate in a technically rigorous environment focused on innovation, compliance, and reliable outcomes for clients and patients.
Role Description 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 Associate 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.
Qualifications
Strategic Leadership
- Develops and implements the site strategy for Quality Engineering and Computer System Assurance(CSA) programs
- Defines key performance indicators (KPIs) and metrics to measure effectiveness of Quality Engineering and CSA programs
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
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
Operational Quality Engineering Support
- 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
Leadership & People Management
- Leads and develops a high-performing Quality Engineering and CSA organization
- Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
Education and Experience
- Bachelor’s degree, preferably in a scientific discipline. Preference will be given to those with an advanced degree
- Minimum of 5 years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry
- Minimum of 3 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