Quality Assurance Manager

Goal:

The Quality Assurance Manager is responsible for leading and managing the implementation, maintenance, and evaluation of quality systems and processes throughout our organization.

Job Duties:

• Implement a harmonized and standardized Quality Management System across all the company’s geographies.
• Manage nonconformity and CAPA processes.
• Oversee and collaborate with stakeholders on regulatory compliance, quality improvement, risk management, internal audits, vendor/site audits, document control, and complaint management.
• Lead the company through internal and external audits.
• Plan, execute quality audits, and report results appropriately in a timely manner.
• Implement and oversee the vendor and the site qualification process.
• Periodic review of company quality documents to ensure up-to-date compliance with EU/USA and other country-specific regulations.
• Implement vendor-qualification questionnaires for providers.
• Periodic review of KPIs.
• Develop company Standard Operating Procedures (SOPs).

Requirements:

• 5+ years of relevant experience and an advanced science degree or legal degree such as BS, MS, MD, or PharmD.
• Deep knowledge and experience in quality assurance in a highly regulated healthcare or clinical trial environment.
• Preferable people management experience.
• Substantial knowledge of industry best practices and trends.
• Is comfortable interacting with clients, regulatory agencies and possesses the ability to represent the company in public forums.
• Demonstrates acumen in resolving challenging audit situations.
• Excellent verbal, written, and interpersonal communication skills.
• Proficient with Microsoft Office Suite, Google Workspace or related software.
• English language proficiency.

The company offers:

• Full-time remote position in a fast growing business of biotechnology
• Excellent professional and career opportunities
• Open-minded executive management
• Friendly and supportive team
• Intellectually stimulating training from the best providers in the biobanking field 
• Attractive salary package
• Medical insurance
• Fully paid vacation and sick leave

Audubon Bioscience is an Equal Opportunity Employer that does not discriminate on the basis of actual or perceived race, creed, color, religion, alienage or national origin, ancestry, citizenship status, age, pregnancy, disability, sex, marital status, veteran status, sexual orientation, genetic information, arrest record, gender identity, or any other characteristic protected by applicable federal, state or local laws.