Quality Management Systems Manager

2 days ago

Monmouth Junction, New Jersey, United States Tris Pharma Full time
Job Title: Manager, Quality Management Systems

Tris Pharma, Inc. is a leading biopharmaceutical company in the U.S. with a focus on developing and commercializing innovative medicines that address unmet patient needs.

Job Summary:

We are seeking a highly skilled Manager, Quality Management Systems to support, oversee, and manage the Quality Assurance (QA) Investigations and Product Quality Complaints Team. The successful candidate will 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.

Key Responsibilities:
  • Assure compliance with all SOPs, cGMP, FDA, and company compliance guidelines, standards, and objectives.
  • Oversee and manage the maintenance and tracking of Quality Systems, including Investigations/OOS/OOT/Lab Event, Product Quality Complaints (PQCs), Corrective Action Preventive Actions (CAPAs), and Continuous Process Improvements (CPIs).
  • Work directly and cross-functionally throughout the company on deviations and PQC investigations relating to production operations, quality operations oversight, and quality control analysis.
  • Review and approve laboratory (OOS/OOT/Lab Event) and manufacturing investigations and CAPAs/CPIs.
  • Perform in-depth data analysis to identify compliance concerns, root causes, and recommend/implement improvements, including CAPAs and CPIs, across departments as appropriate.
  • Apply quality risk management principles in the design (and resolution) of key quality management system elements to ensure compliance.
  • Track and trend deviations and product quality complaints.
  • Engage in activities to continuously assess and improve quality systems by identifying and proactively resolving quality issues.
  • Develop, analyze, and compile quality metrics and highlights; report periodic quality metrics pertaining to investigations/CAPAs/CPIs and PQCs to Quality leadership and other appropriate company personnel.
  • Assist in training, including investigative processes, CAPAs, and CPIs.
  • Participate in regulatory agency inspections and customer audits, as needed; perform and/or participate in internal and external audits, as needed.
  • Manage, coach, and mentor direct reports.
Requirements:
  • Bachelor's 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 the 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 colors.
Preferred Qualifications:
  • Certified Quality Manager, Engineer, or Auditor.
  • Experience with drug-device combination products.
Work Environment:

Office-based position at Tris Pharma, Inc.

We offer 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.

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