Quality Management Systems Manager

4 weeks ago

Monmouth Junction, New Jersey, United States BioSpace, Inc. Full time
Job Summary

We are seeking a highly skilled Quality Management Systems Manager to join our team at Tris Pharma, Inc. The successful candidate will be responsible for overseeing and managing 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 ideal candidate will have a strong background in quality management systems, with experience in implementing and managing quality systems and processes. They will be responsible for ensuring compliance with all SOPs, cGMP, FDA, as well as all applicable company compliance guidelines, standards and objectives.

The Quality Management Systems Manager will work closely with the QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc. teams to ensure timely, accurate, effective and compliant investigation and resolution of deviations and product quality complaints.

The successful candidate will have excellent analytical thinking, problem-solving skills, and the ability to adapt to changing priorities and deadlines. They will also have strong communication and interpersonal skills, with the ability to work independently and collaboratively in a fast-paced, matrixed team environment.

Responsibilities
  • 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 Preventative 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 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
  • 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 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
  • Special knowledge or skills needed and/or licenses or certificates preferred

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