You will join the Quality function and you will be responsible for providing professional expertise for the Quality Risk Management Program at site level.
Leveraging your solid experience in risk management and a goal-drive attitude, you will proactively implement PSG Global Guidelines and Standards for Quality Risk Management Process, including quality of products, facilities, processes and method.
The ability to effectively interact with and influence internal stakeholders at all level will be key.
In this role you will enjoy a global exposure and you will be instrumental in ensuring the plant's growth and ability to meet the need of world-class clients.
You will specifically focus on:
- Develop and maintain quality risk management program for the site;
- Assist Risk Management Activities as defined in Risk Management Standards by using the local SME Team;
- Implement risk management principles, methods and tools, and document template according to Global Standard Procedures;
- Act as primary liaison between the Global Quality Risk Management (QRM) Team and site
- Assist Global QRM Team in identifying, facilitating, and implementing continuous improvement projects related to Quality Risk Management processes and systems at the site.
- Prepare and execute training for site SME in quality risk management principles and practices as per Global Request;
- Member of the QRM Network by assisting Global QRM Team in identifying, facilitating, and implementing continuous improvement projects related to Quality Risk Management processes and systems at the site.
- Oversee timely facilitation and completion of risk activities;
- Revise and maintain updated the Global and Local Risk Register and Metrics;
- Lead the QMR periodic update to the Local Quality Management Review Meeting with SLT;
- Manage data analysis and statistical tools used to support quality risk management activities;
- Communicate the outcome from quality risk management activities and periodic reviews to SLT and Global Team;
- Ensure that periodic risk review are executed and escalated as necessary to the SLT and Global QRM Team in case of criticality;
- Act as site level Quality Risk Management SME and resource for site Quality Risk Management related matters, regulatory Audits and Client Audits.
**REQUIREMENTS AND QUALIFICATIONS**:
- Bachelor's Degree in Science, Engineering, or related fields
**Technical Skills**
- Solid knowledge of current Good Manufacturing Practices (cGMP) and current Good Documentation Practices (cGDP).
- Experience in conducting Quality Risk Assessment in a GXP environment;
- Ability to execute investigations within TrackWise as a SME;
- Strong proficiency in Microsoft Office 365, Teams platform and SharePoint platform;
- Familiar with the following Risk Management Tool: FMEA, FMECA, HACCP, FTA
**Professional Background**
- Requires BS/BA in scientific discipline or related field plus minimum 5-10 years of relevant experience.
May consider significant industry experience in lieu of educational requirement.
- 5-10 years of experience of pharmaceutical manufacturing, Biological Product, medical device/combination product manufacturing, or design and development risk experience
- Thorough understanding and experience with Quality Risk Management principles, tools, and systems.
- Demonstrated leadership skills
**Languages**
- English, fluent
- Italian, fluent