This position reports to the Associate Director, In-Market Quality Country Lead. The following core responsibilities are generally applicable to the In-Market Quality Assurance Specialist role: - Under local Quality Responsible Person (QRP) responsibility, contributes to ensure regulations pertaining to Quality and Compliance for importation, distribution and wholesaling of the products on the markets (e.g. Good Distribution Practice) are fulfilled (where applicable as per the country distribution model
- Supports the implementation and maintenance of a quality system as pertains the activities in scope;
- Supports the development and maintenance of local Quality training program as pertains the activities in scope, including assessment of training effectivenes;
- Contributes to ensure Quality perspective is brought into local business initiatives with Quality impact;
- Has the Quality oversight on management of relevant customer compliants;
- Deviation management, overview and tracking;
- Handling of temperature excursions during transportation, warehousing and distribution
- Oversight of repackaging/re-stickering activities performed by the appointed 3rd party logistics (3PL) provider
- Management of returned goods
- Pharmaceutical Evaluation of Tenders
- Participates in the process of importation of non-registered product in country
- Ensures that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place




- Supports due diligence and audits to assess competence and reliability of external partner(s) and Quality oversight of subcontractors and Third Party Logistics providers (3PLs) to ensure operations comply with regulatory requirements and the conditions specified in the Dossier and in the Quality Agreement. Professional Education and Skills required: - Master's Degree in in pharmacy, biology or equivalent;
- Minimum three years of experience in Quality Assurance (GMP/GDP) within the pharmaceutical industry;
- Documented experience with local, european and international GxP regulations would be an asset and is strongly preferred;
- English language - Proficiency at a business level;
- Teamwork, communication and problem-solving skills. **Required Skills**:
Aseptic Manufacturing, Audits Compliance, Communication, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Driving Continuous Improvement, GMP Compliance, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Root Cause Analysis (RCA), Supplier Quality Management, Test and Evaluation (T&E;), Troubleshooting **Preferred Skills**:
**Search Firm Representatives Please Read Carefully** **Employee Status**:
Regular **Relocation**:
**VISA Sponsorship**:
**Travel Requirements**:
**Flexible Work Arrangements**:
Hybrid **Shift**:
**Valid Driving License**:
**Hazardous Material(s)**:
**Job Posting End Date**:
03/25/2026 **Requisition ID**:R385070

📌 Spclst, Quality Assurance (Roma)
🏢 Msd
📍 Roma