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Manager, Quality Management Systems
2 months ago
Tris Pharma, Inc. ) is a leading privately-owned biopharmaceutical company in the U.S. with a focus on development and commercialization of innovative medicines that address unmet patient needs. We have more than 150 US and International patents including applications and have marketed several branded and generic products in the U.S., have licensed our products in the US and international markets, and have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.
Our science and technology make us unique, but it is our team members that set us apart; they are the engine that fuels Tris' passion and innovation. Tris colleagues understand the criticality of operating a successful business and take pride in the company's success. But of equal importance to each member of the team is how we interact with one another on a daily basis. We believe in each other, and we believe in respectful, open and honest communications to help support individual and team success.
Located in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager, Quality Management Systems (QMS).
Summary:
The Manager, Quality Management Systems (QMS) supports, oversees and manages the Quality Assurance (QA) Investigations and Product Quality Complaints Team to ensure manufacturing quality controls and procedures are followed in accordance with Standard Operating Procedures (SOPs), current Good Manufacturing Practices (cGMPs), Food and Drug Administration (FDA) standards and batch record specifications.
The incumbent uses systems thinking and a holistic systems-based approach to drive compliance and assess operational needs and activities in to accurately, effectively, timely and compliantly achieve quality goals and key performance metrics across multiple quality functions and systems including, but not limited to: investigations, deviations, Out-of-Specifications (OOS)/Out-of-Trend (OOT)/Lab Event, Corrective and Preventative Actions (CAPAs) and Continued Process Improvements (CPIs), Product Quality Complaints (PQC) documentation, compliance efforts, quality operations, etc.
Responsibilities:
Requirements
Minimum education and years of relevant work experience:
Bachelors degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of increasing technical responsibility (minimum 3 of those years in a supervisory or manager role)
Special knowledge or skills needed and/or licenses or certificates required
People management experience
Certified Quality Manager, Engineer or AuditorExperience with drug-device combination products (highly desirable)Travel requirements
0%
Physical requirements
Office based position
Tris Pharma, Inc. offers a highly competitive compensation package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans and women, etc. Tris Pharma, Inc. is an Equal Opportunity Employer. #LI-DNI