349676BR
Aug 09, 2022
USA

Job Description

This role will support associates in Information Governance Management (IGM) and Business Information Management for the site. The incumbent will be responsible for site oversight of non-IT IGM and Business Information Management while supporting GxP activities in the Engineering department. Will also administer Quality Systems/ Processes including documentation and monitoring of actions.

Takes a key role in the execution of the following activities within the local organization:

• Implementation of Information Governance Management (IGM) and Business Information Management procedures
• IGM Manager in RC meetings Tracking of non-IT actions in the gap registers

Policies, Directives, Guidelines (“Regulations”)

• Distribute IGM and Business Information Management regulations to the local IGM Organization
• Collect and provide usability feedback of regulations
• Report any weaknesses in IGM and Business

Information Management regulations to the IGM Manager
Training and awareness:

• Perform training for the IGM Coordinators and identify any additional training requirements based upon IGM coordinator feedback
• Report on training completion at the site level for all IGM awareness campaigns and for routine IM policy training
• Report to the IGM Manager any training gaps with remediation plans
• Distribute training and awareness material to IGM Coordinators
• Attend IGM trainings upon request of the IGM Manager

Provide Support:

• Provide day-to-day support for Local IGM organization in IGM and Business Information Management
• Collaborate with IGM Manager to identify site response to weaknesses identified in Business Information Management
• Creation of security incidents based upon feedback from IGM Coordinators
• Escalate recurring security incidents to the IGM Manager
• Ensure completion of annual physical archive “clean-up” day

Information risk management process:

• Ensure that the IGM Records Inventory is maintained through the local IGM organization
• Support remediation actions and record the actions in the IRM Tool with IGM manager
• Routinely report on the status of non-IT gap actions to the Business Units

Generally support the lifecycle for information regarding:

• confidentiality
• integrity
• availability
• retention

IGM BIM Coordinators:

• Lead the BIM coordinators meeting
• Prepare the agenda for BIM coordinators meeting
• Distribute BIM meeting minutes
• Meet with IGM manager to address BIM initiatives/progress

Additional specific tasks:

• Actively cooperate and share experiences with other IGM Lead Coordinators from the other sites in the region
• Continuously report on issues, risks, exceptions, etc.
• Point of contact of the site document archival and work with offsite archival (e.g. Iron Mountain)
• Ensures the integrity of all Quality Systems records and data, as applicable and collaboration of own team with other functions and departments
• Ensures an adequate level of education, GxP knowledge
• Updates & maintains relevant information in electronic systems (e.g. Change Control, Documentation, Training)
• Follow up and monitoring of Engineering actions (e.g. CAPAs, actions, metrics, Quality plan)

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

• Associate Degree in related field or equivalent training/experience is required.
• Minimum 5 years of relevant work experience is required.
• Experience in regulated environments such as pharmaceutical, medical device, food and beverage is preferred.

Why Sandoz?

500 million patients were touched by Sandoz generic and biosimilar medicines in 2021 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Sandoz!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network

Accessibility and reasonable accommodations:
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877) 395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

While Novartis does not require vaccination at this time, for certain Novartis sites in the US all associates and candidates may be required to either upload an image of their COVID-19 vaccine card demonstrating proof of full vaccination for COVID-19 (or other similar evidence of vaccination) or proof of a negative COVID-19 test taken by the associate or candidate within the past seven days to enter any of our sites and/or customer office or healthcare facility, as well as prior to participating in other work related off-site meetings. Employees working in customer-facing roles must adhere to and comply with customers’ (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to [email protected].
Novartis Technical Operations
NTO SANDOZ TECHOPS
USA
Hicksville, NY
Quality
Full Time
Regular
Yes
careers default image
349676BR

Engineering Documentation Specialist

Apply to Job Access Job Account