Quality Assurance Project Manager - GIPHARMA

260405BR
Quality Assurance Project Manager - GIPHARMA
Advanced Accelerator Applications, a Novartis company, is an innovative radiopharmaceutical company developing, producing and commercializing molecular nuclear medicine theragnostics. AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).

Job Description

We are looking for a Quality Assurance Project Manager for GiPharma, based in Saluggia (VC).

The Project Lead role will serve as the go-to person for the FDA sites in Italy (Ivrea, Forli and Saluggia) for the local and Corporate Quality teams; managing the day-to-day process of fulfilling Quality commitments and initiatives, cross-functional co-ordination and ensuring effective implementation, tracking/reporting and control for the following AAA initiatives:
- Inspection readiness
- Inspection remediation
Additionally will support any key initiatives at the three sites under the lead of the Country Quality Italy Head and GiPharma Quality Head.

MAJOR ACCOUNTABILITIES

General:
Drive the projects and strategic initiatives within Quality and in coordination with other AAA functions
Manage all aspects of project tracking, RAID management (Risks, Assumptions, Issues, and Dependencies), and monitor completed work, milestones achieved, remaining work and key dependencies and resource planning
Ensure that sufficient controls are in place to manage/assess impact of key risks and issues (and that mitigating actions are understood)
Identifies risks of completing / delaying certain milestones
Supporting the sites to deliver Quality activities on time
Leads the design and implementation of solutions for associated risks
Assists with writing and/or review of protocols, reports, data and supportive documentation as needed to ensure full compliance with commitments
Supports business operations and functional activities relating to inspections and remediation (e.g. leadership meetings, cross-functional / country business review preparation)
Assists AAA management in team development and training to improve workflow and general quality
Provide guidance and leadership to ensure that Sites are implementing sustainable CAPAs for deviations, complaints, recalls and inspection observations

Inspection readiness:
Supports the site Quality lead with the preparation of and during inspections, as well as supporting the sites with implementation of related CAPAs
Assists in analysing and detailing additional resource needs to achieve Quality requests
Prepares slides and summarizes status for internal review meetings
Ensures effective communication and promotes good work relationships within the organization
Define and/or agree project metrics and KPIs (to monitor cost, time, resource and risk)

Inspection remediation:
Tracks, follows-up, ensures completion of FDA / inspection commitments, as well as internal Novartis and AAA Quality commitments while observing cGMP guidelines
Supports with sharing knowledge of inspections / CAPAs with other sites, identifying if there are gaps at other sites based on inspection observations, and, if so supporting with implementation of CAPAs.

Minimum requirements

EDUCATION
- Excellent knowledge of cGMP for the pharmaceutical industry
- Pharmacy, Engineering or Science background

EXPERIENCE
- 3+ years of experience in project management / planning
- 5+ years of experience in Quality
- Thought leader with a view to creating a viable PMO service and supporting pragmatic delivery of projects
- Strong communication, leadership and team working skills
- Ability to juggle different projects/priorities and deliver high quality outcomes under pressure
- Capability to provide timely, accurate and relevant project and portfolio reporting as agreed
- Comfortable with coordinating and collaborating with business teams to drive required decisions and outcomes
- Ability to challenge and influence
- Advanced IT skills in relation to Word, PowerPoint and Excel or other project tools
- Able to travel and work in multiple sites as required
Oncology
ADVANCED ACCELERATOR APPLICATIONS
Italy
Saluggia
AAA Italy Srl.
Quality
Full Time
Regular