EvotecGroup

Head of Quality Assurance - Product & Process Development (all genders)

Toulouse Full time

We’re excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine! Click to learn more. 

 

Location: Toulouse, France. 

Type of contract: Permanent. 

 

What You’ll Do: 

 

You lead and manage the strategic and operational performance of the Development Quality department, contributing to the successful delivery of the business strategy, Key Performance Indicators (KPIs) and objectives, whilst adhering to Regulatory and Quality compliance including Sandoz Standards, international & local regulations to achieve success in development projects and ensure the efficient and effective day-to-day running of the Development Quality department. 

 

Ensure adequate QA oversight on all GxP operations in development projects and make appropriate QA collaboration available in all laboratory operations of SDC.  
Manage and lead the Development QA team of SDC. 

 

Major Accountabilities 

·  Lead a group of associates, manage successful execution of Quality Assurance tasks in SDC, plans and align resources, strategies, activities, and processes to handle the given workload. 

·  Assure inspection readiness of SDC. 

·  Assign specific tasks to subordinates and define target dates and priorities. 

· Ensure timely notification, management escalation and reporting of potential quality concerns. 

·   Responsible for the development of direct reports. Mentor, coach, and develop direct reports and manage/ lead a high performing team that delivers continuous improvement and added value. Support a culture of quality, high performance, and trust. 

·  Responsible for implementing applicable Sandoz practices and ensuring sustainability and timeliness. 

· Assure that the required level of knowledge and skills is available and identifies and communicates competency gaps to next level management. 

· Establish and implement training and development plans for team members to close competency gaps. 

·   Set objectives and monitor ongoing progress and performance in a timely manner. Complete regular performance reviews and manage any other people's issues in conjunction with P&O functions. 

·  As a departmental member, interact and collaborate with other departmental members/ groups/ functions to facilitate transfer of knowledge and quality culture. 

·   Maintain relations and interactions with functional management and escalate quality topics as appropriate. 

·   See the bigger picture and therefore consider business and compliance aspects when taking decisions. Challenge the status quo. 

·    Demonstrate leadership. 

·   Adhere to Sandoz values and behaviors, in particular quality, ethical, HSE, and information security (ISEC) standards. 

·   Ensure and actively support communication within the SDC project team(s) and information exchange with other groups/teams within SDC and within the Global Product Development/SDC network as well as local and global QA teams. 

 

Key Performance Indicators 

·   Meet quality and timelines regarding all tasks. 

·   Adhere to Sandoz values and behaviors, in particular quality, ethical, HSE, and informational security (ISEC) standards. 

·  Challenge the status quo and therewith improve the compliance status of development D&R activities. 

·   No critical audit/ inspection findings in SDC due to QMS gaps to be traced back to missing QA oversight or implementation. 

 

 

Who You are 

 
·  Degree in Natural Science (e.g. Pharmacy, Chemistry, Biology) or equivalent natural scientific education.    

 
· Minimum 5 – 10 years of experience within the pharmaceutical industry, e.g. in Quality Assurance, Quality Control, Pharmaceutical Development, Production.

 

·  A professional level of English is required to work effectively within this international team (meetings, technical documentation, etc.). 

· Profound knowledge of GMP regulatory requirements and latest trends. Familiar with ICH guidelines (e.g. ICH Q7, Q8, Q9 and Q10), FDA regulations (21CFR 210-211, Part 4) and EU regulations. 

·  Leadership experience: prepared to motivate people to act towards achieving a common goal by applying the right communication skills/ channels, being inspiring while supervising/coaching a team. 

·  Quality mindset, always looking for improvement and best practice. 

·  Business and customer focused, able to see the broader influence/ big picture and impact of QA on the organization. 

·   Collaboration, cross-functional attitude. 

·   Motivated by challenge. 

·   Resilient and open to initiate and lead change. 

 

Why Sandoz? 

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more! 

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. 

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! 

The future is ours to shape! 

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities. 

 

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.