At Thermo Fisher Scientific team, you'll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.
**Discover Impactful Work**:
The resource will be responsible of a team with multifaceted strengths and will report to the Senior Manager, Quality Operations. The employee will ensure compliance with cGMP regulations, company quality standards, compliance with site GxP processes through the guidance and coordination of Quality Operations Team. The Quality Operation Manager will provide quality support of manufacturing operations, analytical laboratory operations and materials management for Thermo Fisher Ferentino DPS and PDS Business units.
This role will drive, review & support activities related to product disposition including review of batch data, batch records, deviations/investigation, in-process data, EM data, QC release testing and other quality systems documentation. This role must have the vision, drive, and interpersonal skills to succeed in a rapid growth environment. A very equal opportunities positions!
**Keys to Success**:
**Experience**
- Proven experience in similar position within a regulated environment such as, pharmaceutical/biotech or medical devices.
- Recognized by Regulatory Authority to act as Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
**Education**
- Minimum Bachelor's degree required. Chemical, scientific/Technical field such us Biology/Biotechnology, Chemistry, Pharmacy.
**Technical skills**
- GMP regulation (EU and US);
- Specific knowledge of production processes Sterile injectable drugs;
- Sourced from Pharma FDA approved companies;
- MS Office package (Minitab as plus);
- Broad and sound experience with Pharmaceutical Quality Systems (e.g Trackwise) and reporting tools.
**Knowledge, Skills, Abilities**
- Strong knowledge of global cGMP
- Thorough understanding of pharmaceutical law, quality management systems and the professional duties of a QP
- Mathematical and statistical skills
- Experience in quality event management
- Manufacturing and validation environmental experience
- Experienced people leader (direct reports)
- Strong Communication skills
- Data visualization and data analytics (statistics techniques) and continuous improvement
- Strong understanding of the manufacture and supply chain
**Personality traits**:
- Leadership
- Marked Problem solving
- Decision Making
- Excellent communication & negotiation skills
**Languages**:
- English (Excellent)
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.