Senior Regional Quality Assurance Lead Job Baltimore area,Maryland USA,Quality Assurance

We are currently looking for a Senior Regional Quality Assurance Lead to join a multinational company from the healthcare sector to support the region of Saudi Arabia and the Levant countries.

The Senior Regional Quality Assurance Lead will be based in Riyadh, KSA.

Responsibilities

Act as Local Complaint Coordinator for the region.

Product Surveillance activity for Medical Devices in the region:

To ensure effective gathering, recording, transmission to the Product Surveillance team and reporting to the competent Authorities of medical device adverse events
To collect, follow-up, and transmit all local incidents and near incidents to CTPS (Central Team Product Surveillance) using the Global tracking system and archive relevant document
Set up and maintain an efficient Product Surveillance system in compliance with the local medical devices regulations and with the company standard
To ensure appropriate contacts with other organizations such as Regulatory Affairs, Sales and Marketing, etc

Execute Field Actions for the region:

BeFA Contact Person ensuring execution of FAs according to the European local Procedure
Ensure backup for FA Contact personnel in the Gulf region are appropriately trained, and backup are always available.
Ensure processes and procedures are in place in Saudi Arabia and Levant Countries.

Distributor Control:

Manage the distributor/Third parties’ assessment program in Saudi Arabia and Levant Countries.
Perform/document distributor audits; supervise the performance of corrective actions for deficiencies.
Train distributors on the company QMS requirements.
Prepare QA agreements defining the company and distributors' QA responsibilities.

Audit

Prepare Internal and external assessments and ensure positive outcomes.
Perform internal audits.

Supplier QA

Manage the supplier QA program of sponsoring Divisions for products and parts sourced in the Saudi Arabia and Levant Countries (in cooperation with Divisions).
Maintain the approved supplier list.

Training

Assure that systems are in place and maintained to train employees on quality system compliance (including new SOPs). Ensure training records are maintained.
Assure that Distributors and service providers in Saudi Arabia and Levant Countries are trained on GDP and the company requirements.

Compliance

Ensure that the Dubai warehouse and the company’s workshops in Saudi Arabia and Levant Countries comply with the requirements of applicable national laws and the company’s SOPs.
Working with regulatory bodies on external audits & preparing responses
Conducting Distributor's GDP audits.
Good distribution practices implementation within Saudi Arabia and Levant countries.

QMS & Documentation

Implementation of applicable SOPs in the region
Ensuring all relevant SOPs are in place to meet Corporate Quality Manual requirements and ISO 9000 standards
Preparation of new SOPs, distribution, obsoleting & filing of quality documents

CAPA Management:

LeadCAPA in the region.

Other

Maintain and train backups of critical tasks (PQCs, MDRs, FAs, Releases)
Define and control the quality aspects of third-party warehouses
Selling Authorization:
Ensure that products are sold only to authorized entities and fully comply with local regulations and the company’s requirements.
Main contact for Medical Devices Vigilance for Saudi FDA

Qualifications

KSA Nationality - essential
Minimum 4 years of professional experience in quality assurance
Degree in Pharmacy, Natural Science, or equivalent degree in the scientific field
Ability to liaise with the different functions involved, Regulatory Affairs, Vigilance, W&D, Business
Good Management skills
Languages:

English and Arabic

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