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Johnson & Johnson > offerta di lavoro n. 240584

immagine: lavoro con Johnson & Johnson

Senior Specialist Compliance

> 2105927263W

contratto
Assunzione alle dipendenze

durata
Tempo indeterminato

regime orario
Full time

luogo di lavoro
IT Lazio, Latina

area professionale
Legale, Regulatory

livello professionale
Senior

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Descrizione della posizione


Johnson & Johnson is an American multinational company founded in 1886, a world leader in the development of products and devices for surgical therapies and pharmaceutical companies, as well as in the marketing of consumer products for personal hygiene, and is organized into three business segments: Pharmaceutical, Medical, Consumer.

Every day more than 130,000 employees work in 250 companies of the Group, located in 60 countries.

In Italy there are all the three sectors, each of which represents one of the segments mentioned above:

  • Janssen Spa (Pharmaceutical Sector). Marketing Company (Milan). Plant: Borgo San Michele (Latina)
  • Johnson & Johnson Spa (Consumer Sector). Marketing Company and Plant: Santa Palomba (Rome)
  • Johnson & Johnson Medical Spa (Medical Sector). Marketing Company: Pratica di Mare (Rome).

For the production site of Borgo San Michele (Latina) we are looking for a Senior Specialist Compliance in the Quality Department.

Job Scope:

Drive or support the integration of industry best practices and regulatory intelligence into proactive and effective quality processes and systems delivering a lean and agile EQ organization by forming and leading a lean agile central operations group that supports EQ in:

  • Manage Complaints for External Manufacturers where EQ oversees. Establish one common complaint process for EQ
  • Other projects supporting EQ.
     

Essential Functions: Complaint Management

  • Supervise day-to-day EQ Product Quality Complaints process to ensure standard procedure is followed, data is consistent and of high quality, and to provide team members assistance with correct decision making. 
  • Provide direct supervision of EQ complaints team personnel, per guidance of Manager
  • Provide direct support to all members of the EQ complaints team as needed to ensure on-time closure of complaint records
  • Provide training and mentoring to new employees
  • Process and analyze product complaints according to Policies and Standard Operating Procedures.
  • Communicate with External Business Partners to ensure timeliness and review their investigation report for accuracy and completeness.
  • Partner with stakeholders (JJQS, PQV, Internal JSC Manufacturing Sites, External Business Partners, Regional EQ organizations, Call Intake Centers, Global Medical Safety/LSOs, Marketing, Sales Administration, Brand Protection, etc.) to gain knowledge of products and processes.
  • Direct working relationships with internal groups, including EQ Site Managers (globally), ESI Operations, Planning, Clinical (Research & Development GMP), internal site personnel (globally), and External Manufacturers to ensure the depth of investigation required.
  • Develop and generate Monthly Complaint Signal Reports (which typically include the generation of ETS records), including detailed analysis of data, and root cause analysis.
  • Develops and updates complaint handling procedures.
  • Support internal and external audits and inspections.
  • Provide QBR information/reports for Site Managers, including complaint data, complaint timeliness data, and complaint categorization.
  • Support field samples evaluation as backup, as applicable.
     

Quality Metrics:

  • Generate, analyze, and distribute complaints performance metrics on a monthly and quarterly basis as required
  • Lead complaints metrics review during EQ SMR meetings, per guidance of Manager

 

Projects:

  • Lead or participate in organizational driven projects, including, but not limited to the Janssen/EQ complaints process, Janssen/EQ Quality Systems, and Janssen/EQ Business Processes


Qualifications

Requirements:

  • 5+ years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with proven experience in managing external manufacturing operations or Quality Assurance for external manufacturing
  • Exposure to regulatory authorities’ inspections
  • Direct working knowledge of the business environment outside of the quality organization (e.g., manufacturing, product / process development, etc.).
  • •            Full professional knowledge of English (CEFR level B2 and above) and italian (nice to have)

 

Desired:

  • A minimum of an undergraduate degree in scientific subjects is required, and an advanced degree is preferred. 
  • A minimum of 5 years of healthcare industry experience required.
  • Strong analytical and problem-solving skills required. 
  • Excellent computer skills along with extensive experience in PowerPoint, SharePoint and experience with Excel spreadsheets and pivot tables are required. 
  • Ability to work independently in a global environment/virtual team as an individual contributor, team member, and team leader is required.
  • Proven track record of engaging the organization and demonstrating influencing without direct supervision and collaboration skills required. 
  • Strong written and oral communication skills are required. 
  • Demonstrated knowledge and expertise of manufacturing processes, complaint vigilance global regulatory requirements, including 21CFR parts 210 and 211, ICH Q10 and CFR 820.198.  
  • Ability to manage a high workload and deliver to negotiated deadlines is required. 
  • Understanding of Quality and Supply Chain processes & organizational structure is preferred. 
  • Competency in understanding system functionality in relation to process requirements (i.e. Trackwise, ComplianceWire)
  • Ability to build and nurture strong, positive relationships with business leadership and partners in at all levels within Janssen, across the Enterprise and externally with business partners and industry peers.

 

Avvertenze

La presente inserzione è pubblicata allo scopo esclusivo di raccogliere candidature in relazione ad opportunità di lavoro o formazione effettivamente esistenti presso la nostra azienda o presso società controllate o partecipate. È pertanto esclusa qualsiasi finalità di intermediazione. La ricerca è rivolta a candidati di entrambi i sessi (L.903/77). I dati saranno trattati ai sensi del Regolamento UE 2016/679.
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