Manager, Quality Assurance - GxP at PTC Therapeutics, Inc. in SOUTH PLAINFIELD, New Jersey

Job Description:

Job Description Summary:

The Manager, Quality Assurance - GxP supports the implementation of the Quality Assurance (QA) strategy to facilitate specific tasks in compliance with appropriate regulations (e.g., FDA Good Clinical Practices ICHE6, and relevant rest of world regulations), guidance documents, Company policies, and Departmental Standard Operating Procedures (SOPs).

This role involves engaging and collaborating with cross functional internal teams to evaluate study-related processes, procedures, and activities for adherence to relevant industry standards, regulatory guidelines, and company SOPs as appropriate.

The incumbent will support and/or conduct internal and external GCP compliance audits of investigator sites, central laboratories, Clinical Research Organizations (CROs), vendors, clinical study reports, protocol, investigator brochures, submission documents etc. and will assist in inspection readiness activities, Quality Control activities, and the development and review of SOPs.

The incumbent will work cross-functionally with internal departments and external resources on GxP QA related issues and will be accountable for the execution and closure of the assigned GXP QA audit activities ensuring the current regulations at contract facilities worldwide.

The Manager, Quality Assurance - GxP supports adherence to relevant regulatory requirements and company SOPs as appropriate.

Job Description:

Responsibilities:

• Perform audit activities as a lead auditor or as part of a team to ensure compliance with good practices (GXPs), international guidelines, and departmental SOPs.


• Performs assigned internal and external audits to assure compliance with Good Clinical Practices (GCP) regulations; evaluates the quality systems of Contract Research Organizations (CROs), laboratories, and other vendors to ensure that alignment is achieved regarding resolution strategies; champions corrective actions until fully implemented. This includes, but may not be limited to, the following activities:
  
  
  • Schedules, plans, and prepares for audits of investigator sites, CROs, vendors, laboratories, submission documents etc. in accordance with an Audit Plan.
  
  
  • Conducts audit(s) according to approved Study Plans and appropriate regulations.
  
  
  • Communicates audit outcome to stakeholders.
  
  
  • Prepares and submits audit reports for peer review and input.
  
  
  • Assesses audit responses and collaborates with colleagues and QA Management to develop and ensure closure of Corrective and Preventive Actions (CAPA) plans.
  
  
  • Assists with inspection readiness activities for regulatory authority inspections and coordinates tracking of document requests, responses and supporting documentation during inspections.
  
  
  
  


• Maintains effective relationships with colleagues and other departments by working collaboratively to deliver high quality service to the organization.


• Ensures appropriate and timely escalation of quality issues, including issues of significant deviation with projects to QA Management and makes appropriate recommendations for correction and improvement as may be necessary.


• Supports Quality Management System (QMS) implementation efforts involving the development program. This includes, but may not be limited to, the following activities:
  
  
  • Contributes to QA review of SOPs and documentation related to Clinical and Non­Clinical/Toxicology functions, as well as other related documents as required by regulation and as appropriate.
  
  
  • Authors, reviews, and updates GCP compliance related SOPs as needed.
  
  
  • Creates and manages GCP compliance related metrics.
  
  
  • Assists in identifying and communicating clinical/non-clinical trial-related risks and opportunities for process improvement.
  
  
  • Assists QA Management in Corrective and Preventive action - tracking and implementations.
  
  
  • Ensures that documentation, procedures and processes supporting the clinical development program are maintained in compliance with company and industry standards and global regulations.
  
  
  
  


• Engages in quality system continuous improvement initiatives to enforce the quality culture.  


• Performs other tasks and assignments as needed and specified by management.

Qualifications:

• Bachelor’s degree or higher in life science, biology, chemistry, molecular biology, or related discipline and a minimum of 5 years of relevant Quality Assurance/auditing experience in regulated pharmaceutical, biotechnology or related environment and familiarity with GXPs.


• A strong working knowledge of FDA GCP regulations/guidelines, ICHE6 and global clinical regulations and Guidance’s.


• Able to work as a team player: listen, promote exchanges, communicate, adapt, and advise.


• Demonstrated knowledge and understanding of GCP regulations and compliance regulatory requirements.


• Experience conducting audits (investigator, vendor, documents etc.).


• Ability to travel to conduct audits locally and internationally.


• Effective interpersonal skills - ability to work with all levels of personnel.


• Effective oral and written communication skills; ability to communicate issues accurately and precisely.


• Proficiency with Microsoft Office.


• Excellent verbal and written communication skills including the ability to communicate cross-functionally.


• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.


• Analytical thinker with problem solving skills, attention to detail, 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.


• Ability to comply with all applicable SOPs, internal department requirements, and external regulations.


• Experience writing and reviewing SOPs which support clinical/non-clinical trials preferred.


• Knowledge and experience in GCP preferred.


• Clinical/non-clinical Laboratory experience preferred.   


• Registered GXP Quality Assurance Certifications preferred.


• Experience supporting regulatory agency (e.g., FDA) inspections preferred.


• Travel requirement post covid 15-20%


• Remote/Office/Field Based position

EEO Statement:

PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.

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