Job Post: Quality Management Specialist – External Entity Oversight

The company
The aim of our client is to bridge the gaps present in women’s healthcare and make a positive impact on the everyday health of women across the globe. Our client is in search of individuals who share a commitment to prioritize women’s health as a daily practice.

Position Overview
We are seeking a dedicated and skilled Quality Management Specialist to join our team. As the Quality Management Specialist for External Entity (EE) Oversight, you will play a pivotal role in ensuring the highest standards of quality and compliance for the manufacturing of our company’s products at external sites. Your responsibilities will encompass overseeing manufacturing, testing, packaging, storage, and distribution processes, ensuring they adhere to approved methods and regulatory requirements. Your expertise will be crucial in maintaining robust Quality Management Systems and ensuring adherence to company policies and guidelines.

Essential Functions
–Assume responsibility for Quality Management System (QMS) activities at the External Entity (EE) site.
–Provide quality oversight of manufacturing, testing, packaging, storage, and distribution processes at the EE site.
–Ensure products are produced or tested following approved processes and methods, complying with all applicable regulatory requirements and company policies.
–Implement effective and compliant Quality systems in line with regulatory standards, policies, and guidelines.
–Offer technical advice and support to the External manufacture of materials (active pharmaceutical ingredients, intermediates, seeds, and cell banks).
–Provide on-site supervision as required to ensure quality standards are met.

Primary Activities
–Ensure compliance with established Division and Corporation policies and procedures, as well as all relevant domestic and foreign governmental regulations (GMP, etc.).
–Maintain expertise in EQA systems, tools, data, and processes on an ongoing basis.
–Collect and compile metrics, identifying trends and root causes to facilitate the development of Corrective and Preventive Actions (CAPAs).
–Oversee Quality Control functions, including product testing, batch documentation review, change controls, and deviation investigations.
–Support effective complaint management, change control oversight, and review of annual product reviews.
–Operate in a safe and efficient manner, adhering to the Safety and Health Policy.
–Minimal routine travel required for this position.

Qualifications
–Bachelor’s degree in a relevant scientific or engineering discipline.
–Proven experience in Quality Management within the pharmaceutical or related industry.

We also would like to talk to candidates who worked in the following  roles:
-Quality Assurance Specialist
-External Manufacturing Quality Manager
-External Entity Quality Control Supervisor
-Quality Compliance Coordinator for External Manufacturing
-External Manufacturing Oversight Specialist
-Quality Systems Manager (External Manufacturing)
-External Entity Quality Assurance Lead
-External Manufacturing Compliance Analyst
-External Site Quality Manager
-External Manufacturing GMP Coordinator

Other information
Our client is seeking highly motivated talents for different positions, do you want to join them and be part of an exciting journey in the production of contraceptive rod? If you are interested or know someone who is, contact me via the apply button. I would be happy to discuss this opportunity with you.