A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Manager QA, Global EDM QA
Job Description:
The EDM QA Manager is providing quality and compliance governance and oversight for the inte-grated data management Alliance (iDMA) in Integrated Information Science (IIS) and ensures that the systems and processes are fit for their intended purpose and meet all applicable Novartis in-ternal and external regulatory standards.
1. With the support of Senior EDM QA expert and global EDM-QA Management supervision, acts as the single point of QA contact (SPoC) for the iDMA organization related to operations quality and compliance support including incident and change management, process improve-ment initiatives and 3rd party related deliverables.
2. Acts as the quality consultant for process improvement initiatives and supports appropriate metrics /measurement approaches in collaboration with affected Franchises and functional groups
3. Acts as the SME for EDM 3rd party services evaluation, selection, implementation and monitoring.
4. Ensures that GCP Data Management processes and systems are in compliance with applicable regulations, guidance, and Novartis Quality Modules and Policies, by facilitating and ad-ministering a program of review and approval of validation documentation and the support of IA&R, FENs, and IIS Franchise teams and IIS OGD/OTM
5. Stays abreast of changing technologies, analyses impacts and provides guidance/training to iDMA personnel on the impact of those new technologies on regulatory compliance, and po-tential areas of new or changing responsibilities, workflows and business processes.
6. Conducts regular quality reviews of EDM documentation across Business Franchises and EDM functional areas as scheduled.
7. Provides interpretation of GCP regulations, guidelines, policies and procedures, and provides both verbal and written guidance to iDMA and their business partners personnel and con-tracted service providers.
8. Acts as the SPoC for the Dev QA GxP IT Systems and Process team related to all Computer-ized Systems enabling iDMA.
9. Supports Health Authority inspection Preparation, execution and follow-up activities.
10. Acts as an SME and facilitator in incident and change Management processes coordinating between all involved partners.
11. Supports regional Data Management and technical Pharma Development audits as a subject matter expert.
12. Aligns regional, general Dev QA priorities with the local Head of Development QA, Reports to the local Head of Development QA related to general local / regional Development priorities.
Candidate Profile
Science Degree or equivalent Fluency in English (oral and written)
• Minimum 3 years of experience in the pharmaceutical industry, in addition a minimum of 3 years in QA, IT or data management.
• A solid understanding computerized system validation,.
• Very good communication, negotiation and influencing skills, be able to lead, influence and coach complex, cross-functional teams.
• Project management expertise.
• Ability to assess complex DM processes and summarizing the essentials in a format understandable for a variety of stakeholders with very different background.
• Experience in working with numerous and diverse stakeholders in a complex matrix environment, strong customer orientation
• Understanding of latest industry and regulatory trends on e-Clinical Data Management.
• Knowledge of formal quality systems
• Expertise in GCP regulations
• Ability to work independently and in a team environment.
• Graduate degree (Science / Pharma / or related degree preferred
Additional Information:
Experience: 3-4 Years
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 146720BR
End Date: 22nd August, 2014
See All Novartis Jobs B.Sc Alerts B.Pharm Alerts
See All Other Jobs in our Database
.png)
