Director of Quality Assurance

The Director of Quality Assurance plays an integral role in fostering a culture of quality, efficiency, and excellence, ensuring that quality and compliance are integrated into the day-to-day operations and long-term Quality strategy. This position will provide strategic direction and guidance for the Quality Assurance functions to assure end-to-end harmonization of quality processes including risk and GMP core management, and regulatory compliance with worldwide requirements.

The position is also responsible for ensuring that Quality operates in compliance within internal quality system procedures, mitigation of identified compliance and quality risks throughout product life cycle from development to commercialization for the products manufactured at Serán Bio Science.

• Identifies and eliminates risk to continuously improve customer satisfaction and product reliability
• Leads and steers Quality Assurance (QA) Department, including hires and mentors QA personnel, provides constructive and timely performance evaluations, and handles discipline of employees in accordance with company policy
• Leads implementation and continuous improvement of the company’s quality systems and facility validation
• Creates product quality documentation system by writing and updating quality assurance procedures
• Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing
• Responsible for oversight of site activities, assuring that products are manufactured in compliance with cGMP, FDA, and EU guidelines
• Documents authorship, reviews, and approves of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications
• Supports internal audits, client audits and regulatory inspections
• Provides support and oversight of Quality Management Review meetings
• Oversight of a broad range of documentation including, but not limited to User Requirements Specifications (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Controls, and Risk Assessments
• Maintains product quality by enforcing quality assurance policies and procedures and government requirements
• Collaborates with other members of management to develop new product and engineering designs and manufacturing and training methods
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends
• Defines and maintains a strong people management, training, and engagement culture to ensure a high and constantly improving right first-time rate in manufacturing and QC
• Manages the QA budget to ensure that resources are allocated appropriately and that all projects are completed on time and within budget
• Responsibilities may increase in scope to align with company initiatives
• Other related duties as assigned

• General knowledge of aseptic manufacturing processes
• Expert knowledge of GMP guidelines and Quality expectations for preclinical and clinical phase programs
• In-depth understanding and application of cGMP principles, concepts, practices, and standards
• Experience with regulatory inspections by the FDA and EU authorities
• Ability to influence diverse stakeholders and drive accountability and decision-making cross functionally
• Demonstrated ability to partner with other functional groups to achieve business objectives
• Broad knowledge of FDA and international regulations related to GMPs and Pharmaceuticals
• Experience organizing and managing work responsibilities while working independently with minimal oversight
• Time and project management skills with the ability to multi-task and meet deadlines
• Excellent verbal and written communication skills
• Excellent organizational skills and attention to detail
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
• Accepts feedback from a variety of sources and constructively manages conflict
• Strong analytical and problem-solving skills
• Proven ability to lead organizations
• Ability to prioritize tasks and to delegate when appropriate
• Proficient with…