Assoc Director, Quality Compliance Oversight - GCP | BioNJ Talent Services

Assoc Director, Quality Compliance Oversight - GCP

Contact Information
Contact Name: 
PTC Therapeutics
Organization Name: 
PTC Therapeutics
Position Location: 
South Plainfield
Company Profile: 

Translating Science. Transforming Lives.

Our mission at PTC Therapeutics has always been to build an integrated biopharmaceutical company based on our expertise in RNA biology. We have focused on discovering and developing novel oral treatments for patients with serious and life-limiting disorders. By targeting the processes that modulate RNA biology and affect protein production, we bring an innovative approach to drug discovery. We are focused particularly on the development and commercialization of treatments for rare and neglected disorders.

Commitment to Patients.

We are committed to finding treatment options for patients living with life-threatening diseases. Our lead product candidate is ataluren for the treatment of patients with genetic disorders due to a nonsense mutation. Ataluren is in clinical development for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). Ataluren has been approved under the trade name Translarna™ in the European Union for ambulatory patients with nmDMD who are 5 years and older.

Job Description:

Job Summary

The Associate Director, Quality Compliance Oversight - GCP supports the on-going enhancement of PTC’s total quality system by managing quality control (QC) functions related to GxP compliance for, but not limited to, both clinical and non-clinical operations. This involves working with cross-functional internal teams and Contract Research Organizations (CROs) to help develop, implement, manage, and support a quality control strategy and plans that contribute to the PTC ability to achieve and maintain regulatory compliance and ensure quality in a regulated environment. This includes conducting QCO activities in-house as well as site visits to CROs and clinical sites involving data checking and assessing clinical monitors for contract compliance.

Primary Duties/Responsibilities

The incumbent works cross-functionally with internal departments and external resources on Quality related issues.

•Directs and supports QC activities involving Quality Management System (QMS) relating to GCP.

•Performs quality compliance oversight activities to assess contracted operations such as monitoring, to ensure overall quality, and compliance with study defined plans and contractual obligations.

•Conducts, reports and documents quality oversight activities according to PTC standards.

•Follow-ups on quality compliance oversight reports to assure proper corrections were made.

•Performs quality checks on various operations involving GxP areas both in-house and at contracted operations, as required.

•Assists, in conjunction with the PTC clinical team, the development of Corrective and Preventive Action (CAPA) plans relevant to process improvement, following internal/external audits/inspections, as assigned by the Head of Quality.

•Reviews data listings in conjunction with relevant departments/personnel.

•May provide guidance to others performing QC activities on regulatory submission documents.

•Performs activities according to relevant SOPs, regulations and GxPs.

•Assists in developing strategic plan for QCO activities.

•Continuously evaluates/assesses processes and procedures for potential improvements and may work in conjunction with various departments including Compliance Learning to ensure implementation of these improvements, as appropriate.

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

Qualifications: 

Minimum level of education and years of relevant work experience

•Bachelor’s degree in a scientific discipline and minimum of 7 years of progressively responsible experience in Quality roles at least 5 of which were in clinically focused, quality-related positions in a pharmaceutical, biotechnology or related environment OR equivalent experience and/or education.

* Special knowledge or skills needed and/or licenses or certificates required.

•Detailed, working knowledge and understanding of GCP regulations and Regulatory Authority requirements.

•Ability to lead without direct authority.

•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 thinker 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.

*Special knowledge or skills and/or licenses or certificates preferred.

•Knowledge and experience in Good Laboratory Practice (GLP) regulations.

•Experience with monitoring clinical sites in a CRO environment.

•Experience working directly with clinically focused operations involving QC activities.

•Experience working in a clinical lab.

•Experience with QA auditing.

* Travel requirements

10-30%

*Physical requirements (only note if the job requires physical capacity beyond general office work:

Office/Field Based position

Additional Job or Internship Information
Position Type: 
Full time job
Function: 
Quality Assurance