~~~Please note: This is a temporary contractor opportunity at Novartis ~~~
Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life!
Novartis US partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit
Ready to work with/through Magnit at Novartis? Please read on...
The Validation eCompliance Manager manages the QA activities related to GxP BR Systems to assure BR system processes & applications comply to Novartis computer system validation (CSV) requirements and remain compliant throughout their life cycle in alignment with e-compliance requirements.
The role will work closely with Quality e-compliance associates, IT, technical and Bioanalytical Laboratory business partners to provide knowledge and assure compliance to Novartis and regulatory requirements.
1. Represent BioMedical Research Quality as eCompliance SME on project validation team(s) overseeing expectations associated with validation and qualification strategy and deliverables.
2. Review/Approve Validation and Qualification deliverables for assigned projects.
3. Ensure strong communication within QA organization and with project teams regard-ing expectations, status and any risks/issues.
4. Anticipate, monitor, report and, as applicable, escalate any CSV and eCompliance risks.
5. Other responsibilities as assigned to support the QA role associated with the new laboratory implementation.
Key Performance Indicators
1. Feedback from key stakeholders (BR Quality, Business partners, System owners).
2. Independent/confident and empowered completion of assignments with minimal management oversight
3. Timely & compliant execution of QA activities to meet project timelines.
4. Demonstrate active collaboration in projects to assure implementation of “best practices” on the domain.
5. Contribute to continuous improvements/enhancements to benefit business.
Education: (minimum/desirable):
Bachelor of Science IT/Engineering/Scientific discipline. Equivalent experience may be considered.
Languages: Fluency in English (oral and written). Additional languages such as Spanish, French, German considered a plus.
Experience:
• 6+ of practical experience in pharma/Biotech industry
• Broad knowledge of IT/Software/Medical Device regulations including practical experience.
• In-depth knowledge of Industry Quality Standards (GLP, GCP, ICH, FDA Part 11, ISO 13485)
Technical Skill Set:
• Knowledge of analytical methods and software
• Good working knowledge of GLP /GCLP Scientific areas and relevant IT systems.
• Good knowledge of the System Development Life Cycle
• Ability to grasp new technologies quickly.
• Strong risk management skills
Personal Skill Set:
• Good interpersonal, negotiation and communication skills (written and oral)
• Innovative, analytical, conceptual & detailed oriented mindset
• Demonstrated ability to partake in interdisciplinary projects with a wide range of business functions and successfully work in global cross-functional matrix.
• A clear sense of personal accountability, ability to drive quality culture with partners and a high degree of mutual respect and integrity are essential factors to succeed.
Location: East Hanover, NJ (Hybrid)
Pay Rate: $70 - $91.88 based on skills/qualifications (W2 Only)
Contract: 6 months
Health, dental, vision, 401k
Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe we can reinvent what's possible when we collaborate with courage to ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine the impact you could make here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.
To do our best work we need different viewpoints, which is why here at Magnit, we celebrate diversity and embrace inclusion. As an equal opportunity employer, Magnit is dedicated to building a team that represents a variety of backgrounds, perspectives, and skills. We strive to ensure that we maintain a positive and enriching work environment for all.
Accommodation:
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [email protected].
Commitment to Diversity and Inclusion / EEO
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