Quality Manager/ Sanofi Pasteur Responsible Person

Job Purpose:

Sanofi Pasteur is seeking a highly skilled and experienced Quality Manager to join our team in Turkey. As the Quality Manager, you will be responsible for managing the implementation of the Country Quality System across the Turkey Country Offices for GenMed, Speciality Care, and Sanofi Pasteur GBUs. Your role will involve ensuring compliance with local health regulations, Sanofi Global Quality rules, and acting as the responsible person (QP) for Sanofi Pasteur. You will play a crucial role in ensuring the availability of safe, efficient, and quality products, information, and services to meet the needs of patients and customers.

Responsibilities:

• Manage the implementation and maintenance of a local quality system that complies with regulatory requirements and internal quality reference standards.
• Coordinate with all concerned Country functions responsible for GxP and health-regulated activities to ensure the efficient and effective operation of the Country Quality System.
• Act as the backup Country Quality Head Turkey and provide coordination and guidance to quality associates.
• Develop and manage local Quality Documents (QDs) for GxP and health-regulated activities in collaboration with relevant functions.
• Ensure compliance with quality risk management activities, including identification, anticipation, and assessment of quality risks, and the development and implementation of appropriate action plans.
• Oversee the quality performance indicators and participate in quality projects.
• Coordinate and support audits and inspections, including liaising with regulatory authorities and attending Turkish MoH GMP inspections as the Quality Representative.
• Manage deviations and Corrective-Preventive Actions (CAPA) related to GxP and health-regulated activities.
• Implement a change control management process for GxP or health-regulated processes or operations.
• Handle country quality agreements and service agreements with third-party suppliers and subcontractors.
• Ensure compliance of GxP computerized systems with regulations and Sanofi standards.
• Ensure the quality of products, including managing product technical complaints, product-related quality events, and the temperature release of incoming shipments.
• Provide quality oversight on local manufacturing operations, including managing quality agreements, monitoring compliance, and conducting site visits/audits.

Requirements & Qualifications:

• University degree in Medicine, Chemistry, Chemical Engineering, or Pharmacy.
• Minimum of 10 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.
• Strong knowledge of relevant regulations, guidelines, and good practices applicable to Country Organization operations.
• Ability to interact effectively with Turkish Health Authority.
• Fluent in English, both written and spoken.

Competencies:

• Autonomy and ability to prioritize tasks with a sense of urgency.
• Analytical mindset and ability to make decisions without compromising quality.
• Strong negotiation and communication skills.
• Integrity, resilience, and adaptability in complex situations.
• Ability to work collaboratively and cross-functionally.
• Demonstrated leadership skills and flexibility.

What Sanofi Can Offer You

• Benefits to enhance your life journey
• Development opportunities to own your future
• An open and inclusive environment where you can be yourself
• Social activities and wellbeing programs to support your life

We chase the miracles of science to improve people’s lives.

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

Our factory in Lüleburgaz is one of the leading pharmaceutical manufacturing plants in Turkey. 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.

Pursue progress.

Discover extraordinary.

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.

So let’s be those people.

Let’s explore more, and share a purpose, as well as our skills. Let’s reinvent healthcare, chase change, and embrace new ideas. Let’s take bigger risks and find better solutions for the people we help.

Let’s pursue progress.

And let’s discover extraordinary, together.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.