Quality Specialist

Job title: Quality Specialist

• Location: İstanbul

About Job

• Ensure the implementation and maintenance of appropriate Quality System covering the GxP activities within the MCO Quality Organization
• Support driving Quality & Process Management related activities and contributing to improve quality management related systems in the Country Organization
• Ensure and guarantee Product Quality in relation with the International and Local Standards and requirements
• Support the adequate management of third parties across the MCO Quality Organization

To achieve success it is critical that the Country Quality Specialist:

• Fosters a cooperative environment with internal and external stakeholders
• Takes decisions based on factual data, inclusive of all components
• Always seeks improvement in local practices

KEY RESULTS/ACCOUNTABILITIES

I. Quality Management System

1. Quality Documents

• Ensure a consistent management of country Quality Documents related to GxP and health regulated activities within the country using the appropriate tools
• Maintain an updated mapping of GxP Quality Documents within the MCO Organization. Ensure that the mandatory quality documents are in place
• Assist in the issuance of Quality Standard Operating Procedures and their related training
• Provide guidance to GxP country functions that need to develop country Quality Document
• Coordinate the impact analysis of released updates of global quality documents and local regulations to ensure that the requirements are transcribed into country quality documents within timelines
• Assist in the training of GxP employees on related Quality processes
• Verify the proper implementation of the above process, when needed

2. Deviations Management and Corrective-Preventive Actions (CAPA) Management

• Implement the process to manage deviations & CAPAs related to GxP and health-regulated activities
• Help in establishing the appropriate CAPA for deviations, where applicable
• Follow-up on the implementation of the planned CAPAs and their effectiveness measurement

3. Country quality performance indicators (QPIs):

• Maintain an efficient tracking system across all Quality activities to allow an easy data extraction and analysis related to Country QPIs
• Periodically report country QPIs defined by the operational quality unit in charge of the MCO Quality organization (in addition to any other locally defined quality indicators)
• Follow-up with GxP departments on their specific QPIs

4. Change Management

• Implement the process to manage the changes that may impact GxP or health-regulated process or operations by following multidisciplinary exchanges and action plans as applicable

5. Non-product related quality events

• Escalate and manage the events occurring at the country according to defined processes and standards

6. Audit and Inspection Readiness

• Support in the quarterly running of the Inspection Readiness Tool
• Support in any audit or inspection preparation and related follow-ups and CAPAs

7. GxP Computerized Systems

• Ensure the maintenance of an up-to-date local inventory, together with relevant IS functions and that local computerized system in use within the country for GxP activities are in compliance with regulations and standards

8. Internal and Country Reconciliation

• Initiate and manage the internal and country reconciliation to cover Medical Information, Pharmacovigilance, Product Technical Complaints and Counterfeit
• Ensure proper documentation and tracking of this procedure

9. Trainings

• Assist in the Quality induction training of new comers
• Perform routine Quality trainings to GxP departments, according to the established training plan

10. MCO Quality Review

• Assist in the data collection, analysis and preparation of the MCO Quality Review presentation and report

II. Product Quality

11. Product Technical Complaints (PTCs)

• Manage PTCs received by the country organization according to defined Quality Standards & processes and in connection with Global Quality Functions (PTC global database) and other relevant units
• Ensure follow-up on pending cases until their closure
• Update PTC tracker in a timely manner
• Maintain an adequate documentation and filing system
• Conduct PTC trend analysis and signal detection, as appropriate

12. Temperature Excursions

• Manage Temperature Excursions related to the inbound shipments and local storage and shipments in accordance with the established flows and processes
• Provide release decision in alignment with the Country Quality Head
• Ensure follow-up on pending cases until their closure
• Track the Temperature Excursions in a timely manner

13. Product Related Quality Events

• Assist the Country Quality Head in any product related quality event / alert across countries from its identification, tracking and reporting until its closure

III. Third Party Management

14. Third Party Quality Oversight

• Ensure an appropriate quality oversight process of locally managed subcontractors for all GxP and health-regulated activities, either directly (being involved on selection process, qualification and performance of audits) or through coordination with the concerned country functions (as appropriate)

15. Quality Agreements

• Assist the CQH in the review and implementation of the Quality Agreements, where required

16. Third Party Reconciliations

• Initiate and manage the Third Party reconciliation to cover Medical Information, Pharmacovigilance, Product Technical Complaints and Counterfeit
• Ensure proper documentation and tracking of this procedure

IV. Quality Culture

• Ensure appropriate communication of key messages pertaining to quality across the organization, highlighting their possible business impact
• Assist the CQH in drafting and performing quality related trainings for the countries
• Suggest and implement new initiatives aiming at continuously improving Quality awareness at local level

KEY WORKING RELATIONSHIPS

INTERNAL

Regular, close contact with:

Cross Functional Collaboration with:

• All GxP departments (Medical, Clinical, PV, Regulatory, Industrial Affairs and Supply Chain)
• Business Units
• Sanofi Manufacturing Sites and Distributions Centers
• Global Functions
• Quality Supply Chain
• Quality Alert Teams
• Quality Third Party Management Teams

Occasional Contact with:

• Internal Controls
• Procurement
• Human Resources

EXTERNAL

Regular, close contact with:

• Contract Manufacturing Organizations
• GxP Third Parties:
• Suppliers

About Us

• University degree in Medicine, Chemistry, Chemical Engineering, or Pharmacy.
• Minimum of 5 years of experience in Quality within the pharmaceutical industry.
• Minimum of 2 years of experience in a pharmaceutical manufacturing site in Quality Control, Quality Assurance, or Manufacturing Quality units.
• Fluent in English, both written and spoken

Competencies:

• Ability to prioritize tasks with a sense of urgency.
• Strong negotiation and communication skills.
• Integrity, resilience, and adaptability in complex situations.
• Ability to work collaboratively and cross-functionally.

Why do you choose us?

We are Sanofi, an innovative global healthcare company. We chase the miracles of science to improve people’s lives.  

Our team, across some 100 countries, is dedicated to transforming the practice of medicine by working to make the impossible into the possible. We provide potentially life-changing treatment options and life-saving vaccine protection to millions of people globally, while putting sustainability and social responsibility at the center of our commitments.

We are one of the largest pharmaceutical companies in Turkiye, serving public health for with more than 1,600 employees. Adding value to local economy and development in Turkiye, we offer a broad range of products including innovative therapeutic solutions, biotechnological pharmaceuticals, vaccines, and consumer healthcare products.

Our factory in Luleburgaz is one of the leading pharmaceutical manufacturing plants in Turkiye. It is also among the top three Sanofi production sites worldwide in terms of its manufacturing capacity. Our manufacturing site produces high-quality pharmaceuticals in many different forms in accordance with global health standards and develops generic medicine at its on-site R&D Center.

We do not stop there, Explore:

Hybrid Working Options (for Istanbul HQ and for eligible white collar positions at M&S site)    

Comprehensive Medical Plan

Company Private Pension Plan  

Flexible Benefits Program for YOU to design your benefits

Company car for eligible positions & attractive lunch voucher/cafeteria at M&S site

Birthday Leave to celebrate YOU

14-week Parental Leave

Employee Stock Purchase Plan dedicated to Sanofians

Kindergarten Allowance for female employees

Employee Assistance Program

Access to various learning & development resources, career development opportunities

& MORE!

Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.

At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.

Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!