- Assures compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectives
- Oversee and manage the maintenance and tracking of Quality Systems including, but not limited to Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs) and Continuous Process Improvements (CPIs)
- Works directly and cross functionally throughout company (i.e., QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC investigations relating to production operations, quality operations oversight and quality control analysis and overseeing and ensuring timely, accurate, effective and compliant investigation and resolution
- Reviews and approves laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs
- Performs in-depth data analysis to identify compliance concerns, root causes and recommend/ implement improvements, including CAPAs and CPIs, across departments as appropriate
- Applies quality risk management principles in the design (and resolution) of key quality management system elements to ensure compliance
- Tracks and trends deviations and product quality complaints
- Engages in activities to continuously assess and improve quality systems by identifying and proactively resolving quality issues
- Develops, analyzes and compiles quality metrics and highlights; Reports periodic quality metrics pertaining to investigations/CAPAs/CPIs and PQCs to Quality leadership and other appropriate company personnel
- Assists in training, including but not limited to: investigative processes, CAPAs and CPIs, etc.
- Participates in regulatory agency inspections and customer audits, as needed; Performs and/or participates in internal and external audits, as needed
- Manages, coaches and mentors direct reports
- Any other assignments determined by the management
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
- Strong hands-on knowledge of cGMPs in the pharmaceutical industry and application of current Good Documentation Practices (cGDPs) within pharmaceutical industry
- Experience implementing and managing quality systems and processes
- Familiar with US FDA guidance and other international guidelines on Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
- Strong working knowledge of pharmaceutical investigation process and ability to conduct, lead and/or draft effective investigations
- Proficiency with Microsoft Office
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
- Fluent in English (verbal and written)
- Ability to identify and distinguish colorsSpecial knowledge or skills needed and/or licenses or certificates preferred
- Certified Quality Manager, Engineer or Auditor
- Experience 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
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Manager, Quality Management Systems - Monmouth Junction, United States - Tris Pharma
Description
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:
Manager, Quality Management Systems professionals in Monmouth Junction
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