Sr. Manager, R&D Quality

AbbVie

Annecy, France

Job Description

Join AbbVie as our new R&D Quality Assurance Senior Manager at Our Pringy Site!

Are you passionate about ensuring the highest standards of quality in medical device development? Do you thrive in a leadership role, driving strategic quality initiatives? At AbbVie, we're searching for an experienced professional to lead our R&D Quality Assurance team at the Pringy site.

Your Impactful Role: As the R&D Quality Assurance Senior Manager:

You, and your team (5-6 people), ensure that new Medical Device products from the Pringy site are developed in accordance with Global regulatory requirements, AbbVie quality standards and customer expectations. You will be responsible for overseeing all aspects of Quality for Research and Development of Aesthetic Filler products, including Design Controls, Risk Management, Design Changes and Clinical Batch Manufacturing.

You define the site's R&D quality strategy and establish a culture of quality to guarantee the robustness of our products. You use your expertise to partner with and influence cross-functional team members in various departments, including R&D, Operations, Medical Safety, Clinical, Project Management and Asset Strategy leaders. You manage the site’s R&D Quality Systems, including CAPA, Training, Metrics, and Document Control compliance. You represent the site in Internal and External Audits as a Subject Matter Expert in R&D Quality.

You are the site's R&D QA representative at global meetings related to the harmonization of the quality management system, risk management, and design control processes. You take part in global R&D quality initiatives and ensure the deployment of these initiatives on site.

You act as a key person in the transformation of the Quality R&D culture on the site and deploy the Quality culture among your partners.

Qualifications

You have assets to join us:

A higher scientific education Bac+5 (Engineering Degree preferred) with a minimum of 12 years of experience in the Medical Devices industry and minimum 5 years of experience in team management;
Proven expertise in interpreting and applying medical device standards and regulations, including ISO 13485, 21 CFR Part 820 quality system regulation, ISO 14971, MDR, and IEC/EN 62366;
Solid experience in reliability analysis, test methods and validation of test methods;
Extensive knowledge and experience with corrective action and preventive action systems, statistical process control, quality risk management, Design Change Management, Failure Modes and Effects Analysis (FMEA), Design of Experiments (DOE), and other key tools for managing quality performance;
Experience in managing major projects within a complex matrix organization;
Motivating leader that can coach and develop team members with varying levels of experience;
Strong project management skills within a matrix organization;
Fluency in English (written and oral) required;
Excellent verbal (presenting, facilitating, facilitating, influencing) and written communication skills (writing technical reports);
The ability to manage and solve complex problems and to propose effective solutions;
In-depth strategic understanding of priorities and decision-making abilities;
A strong collaborative spirit and sense of teamwork.