About Morgan McKinley
Our client is a forward-thinking pharmaceutical company committed to delivering quality medicines that make a meaningful difference in the lives of patients.
Job Description
The Senior Quality Auditor will play a critical role in ensuring compliance and quality in supplier management, while contributing to global healthcare. The successful candidate will be responsible for mentoring and developing team members, overseeing the lifecycle management of approved vendors and suppliers, and collaborating cross-functionally with departments such as Supply Chain, Regulatory, and Quality.
Key Responsibilities:
* Mentor and develop team members to support their professional growth
* Oversee the lifecycle management of approved vendors and suppliers in line with industry regulations and guidelines
* Collaborate cross-functionally with departments such as Supply Chain, Regulatory, and Quality
* Travel nationally and internationally as part of the role's responsibilities
* Deputize for the Senior Quality Manager - Supplier Assurance as required
* Establish and monitor KPIs, providing evaluations and reporting on related metrics
* Manage a risk-based audit program for vendors and suppliers used in the client's products (excluding Pharmacovigilance suppliers/partners)
* Conduct risk analysis-based outcomes on Quality audits, collaborating with QPs and management on follow-up actions
* Ensure audits meet current EU GMP, EU GDP, or equivalent standards, as well as relevant marketing authorization (MA) requirements
* Maintain and track CAPAs (Corrective and Preventive Actions) internally and with external suppliers
* Keep vendor data valid and up to date in the SAP ERP system
* Evaluate and interpret global regulations for audit activities
* Create, revise, and review documentation related to QA audit checklists, questionnaires, and other SOPs/guidance documents as required
* Support additional activities at the discretion of the Senior Quality Manager - Supplier Assurance
Requirements
To be successful in this role, you will require:
* A degree in Chemistry, Pharmacy, Microbiology, or a related field
* General Auditing Qualification
* External Lead Auditing Qualification
* At least 2 years of experience in a similar role within the pharmaceutical industry
* Strong organizational skills with the ability to prioritize and work under pressure