Quality Assurance Manager

Serán BioScience is seeking a Quality Assurance Manager to oversee the day-to-day operations of the Quality Assurance department. Required attributes include a results-driven and broad-minded quality assurance professional with extensive experience in compliance and regulations, quality systems management, investigations, training and mentoring, client relations, performance management, and change management. Experience with analytical laboratory or manufacturing operations is desired. 

Successful candidates will have excellent problem-solving skills and will identify critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments. Preference given to candidates who have proven leadership abilities with greater years of experience and broad knowledge and of FDA and international regulations related to GMP within a pharmaceutical manufacturing setting.

• Leads and mentors Quality Assurance personnel  
• Provides constructive and timely performance evaluations 
• Handles discipline of employee in accordance with company policy
• Hires, trains, and mentors new staff members

• Oversees management and scheduling of department operations 
• Leads Quality System improvements, Investigations, CAPAs, Change Management, Document Control, Validation, and Auditing 
• Identifies critical quality objectives, develop cross-functional, collaborative, and creative teams, and improve, adapt, and execute practical solutions in competitive and fast-paced environments 
• Performs document authorship, review, and approval of SOPs, batch production and quality control (QC) records, certificates of analysis, method validations, and equipment qualifications 
• Oversees of a broad range of documentation including, but not limited to User Requirements (URS), Functional and Design Specifications, Testing Protocols (IQ/OQ/PQ), Change Control, and Risk Assessments 
• Support internal audits, client audits and regulatory inspections, as needed 
• Work with cross-functional teams to troubleshoot equipment, process, testing, and validation issues 
• All other duties as assigned 

• Broad knowledge 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 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 
• Proficient with Microsoft Office Suite or related software 

• Minimum of a bachelor’s degree, preferably in a scientific discipline
• 5 years previous GMP and Quality experience in the Pharmaceutical or Biotechnology industry 
• Experience with regulatory inspections by the FDA and EU authorities is desired 

• Prolonged periods of sitting at a desk and working on a computer 
• Must be able to lift up to 15 pounds at times