Job Description Summary

Standard activities or routine tasks include batch record and related document (log books, other controlled docs) issuance and review, etc. Manage Document Control area and support related systems for document management and archival. Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP in TRD.

Job Description

Major accountabilities:

Manage Doc Control Room and related activities such as support issuance, review and approval of batch records and related documents including but not limited to logbooks, labels, Tech Docs etc.

Write and review GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
Support site audits and other projects as required.
Review / Approval of Change Controls, QE, CAPA and actions.
Review / Approval of documents in document management systems such as ESOPS D2, CONDOR, SUBWAY.

Key performance indicators:

In accordance with departmental objectives such as support of projects with agreed quality and delivery dates, passing of internal and external inspections.
Maintain sound working relationship with internal customers and external partners.
Meet quality and timelines in area of responsibility.
Feedback from team members.
Act in accordance with Novartis standards in particular; cGMP, ethical, health, safety and environment (HSE), and information security (ISEC).

What you'll bring to the role:

BS degree in Scientific discipline or engineering related field with significant prior experience (3+years) or equivalent. Fluent English (oral and written).
Communication skills to sufficiently address GMP and logistic related questions with line unit experts.
Knowledge of cGMPs and understanding of the concepts of GDP and Data Integrity.
Good organizational skills.
Ability to communicate effectively with cross-functional groups in various aspects of company operations.

Novartis Compensation and Benefit Summary: The pay range for this position at commencement of employment is expected to be between $77,400 and $143,000 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

You'll Receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits-rewards

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

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.

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 to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or 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.

Salary Range

$77,000.00 - $143,000.00

Skills Desired

Agility, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise