Senior RQS Manager

Job Description:
At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology, and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world. 
Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging, and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organization and as professionals.
Together we can influence the world around us to make life and work better.
Ferring+You   
The RQS Manager leads the Regulatory Affairs strategy and Quality Management System in Italy, guiding and supporting the regulatory, quality, and pharmacovigilance teams.
Reporting directly to the General Manager and as a member of the Italian Management Team, the RQS Manager also ensures quality and safety standards are met, including oversight of audits, CAPA, complaints, and recall processes, while fostering team performance and development.
Your day at Ferring  
The RQS Manager leads the Regulatory Affairs, Quality, and Safety strategy in Italy, guiding and developing the local RQS team while ensuring high efficiency, motivation, and effective coaching. The role acts as Ferring’s official representative with AIFA and other Health Authorities, including serving as delegate for the Medical Device Ministerial Database, and serves as Local Safety Officer (LSO), Local Complaints Coordinator (LCC), and Local Recall Responsible Person (LRRP) , overseeing the timely execution of recall processes and safety reporting. The role also involves interacting with other regulatory associates, cross-functional teams, and participating in global and regional projects, industry trade groups, and professional societies.
The role encompasses three main areas of responsibility :
Regulatory Affairs
Develops and executes long- and short-term regulatory plans in line with company objectives.
Oversees timely submission, registration, and maintenance of all products in Italy.
Ensures compliant labeling, advertising, and promotional materials.
Provides regulatory advice to management and participates in business planning.
Maintains regulatory intelligence, monitors local and global changes, and communicates updates internally.
Collaborates on pricing, reimbursement, and negotiations with Institutions in coordination with Market Access.
Quality Management
Manages and coordinate local QA and compliance activities, including audits, CAPA, deviations, complaints, and Trackwise reporting.
Supervises the Quality team, ensuring efficient processes and high department morale.
Leads the preparation, maintenance, and tracking of procedural documents, SOPs, manuals, and policies.
Educates and trains employees on QA and compliance matters.
Safety & Pharmacovigilance
Oversees PV and device vigilance activities, ensuring compliance with internal and regulatory requirements.
Coordinates timely reporting of safety and recall matters to Health Authorities and Headquarters.
Behind our innovation…There’s you  
 

• Degree in Pharmacy, Medicine, or Health Sciences.
• Strong communication and administrative skills.
• 5–10 years of experience in Regulatory Affairs, with proven people management experience.
• Solid understanding of GDP, GLP, GMP, GCP, and ISO regulations.
• Knowledge of international guidelines and national legislation related to drug registration, GDP, and Pharmacovigilance.
• Fluency in English and Italian (or local language).
• Experience with IT systems such as TrackWise, Veeva Regulatory, Veeva Promomats, and SAP.
  

 
People come first at Ferring  
Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love. Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role. Parental leave for both birthing and non-birthing parents. Extended support on family building journey 
 
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You. 
Behind our purpose… There’s you  
If our mission and your vision are aligned, please apply! 
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status. 
Note to agencies: this search is being managed by Ferring’s Talent Acquisition team. Kindly do not send us spontaneous profiles. 
Location: Ferring Italy