Small Molecule & Oncology Complaint Lead

Highly Competitive
  1. Permanent
  2. Good Clinical Practice (GCP)
  3. United States
Somerville, Massachusetts
Posting date: 12 Jun 2019
QA.SH.23830_1560355186

An internationally leading pharmaceutical company is seeking to recruit a Small Molecule & Oncology Complaint Lead to their office in Massachusetts. Specialising in multiple therapy areas, the company boasts a superb pipeline with products that include treatments for diabetes, cancer and asthma. This is an exciting opportunity to work with a company that operates in over 90 countries across the globe.

Job Responsibilities:

  • Initiating, writing, and managing the complaint investigation to completion.
  • Serving as the point of contact for commercial & clinical product complaints and post market product vigilant monitoring processes.
  • Receiving, initiating, investigating, and concluding product complaint investigations using the current product complaints management software, coordinating all aspects of investigation through closure, and/or providing oversight for complaint handling process.
  • Applying departmental procedures to assess product complaints' impact on patient safety and product quality compliance.
  • Assessing product complaints and determining if escalation is required due to potential regulatory notification requirements.
  • Interfacing and collaborating with various departments including the OpUs, External Supply, Quality Assurance, Regulatory, Development, Safety/Pharmacovigilance, etc. and the regional organization.
  • Interfacing with external stakeholders such as CMO, Call Centers, and vendors/contractors on product complaint issues.
  • Assuring that all product complaints are investigated to the appropriate level within the required timeline.
  • Critically reviewing and approving complaint investigations and sending customer response letter.
  • Representing the company as the Subject Matter Expert (SME) for the product complaints process during Internal, External and Regulatory Body Inspections.
  • Driving continuous Improvement.

Skills and Requirements:

  • Bachelor's degree.
  • A minimum of 6-12 years of experience in Quality Assurance or a GMP related field within medical device, biotechnology, or pharmaceutical manufacturing.
  • Working knowledge of cGMPs and other regulatory requirements governing combination drugs and device products.
  • Knowledge of EU/ FDA cGMP requirements pertaining to drug/device product complaints reporting and investigation.
  • Desirable experiences: combination working experiences in product complaints handling, deviation management, CAPAs, quality compliance investigations, risk management, and cGMP audits.
  • Good understanding of the manufacture of combination products and the linkage to customer complaints.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sherron Howard at +1 267 435 8600 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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#Compliance/Quality

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