Director of Commercial Quality Assurance presso Serán BioScience

Duties and Responsibilities

• 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

Required Skills and Abilities

• 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 Microsoft Office Suite or related software

Education and Experience

• Bachelor’s degree in a scientific discipline; advanced degree is preferred.
• Requires a minimum of 10 years of GMP and Quality experience in the Pharmaceutical or Biotechnology industry
• Requires a minimum of 5 years in a QA management role

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 a time
• Adheres to consistent and predictable in-person attendance