345364BR
May 24, 2022
India

Job Description

5! The number of projects you will be leading to develop our growing pipeline of Gene Therapy products. We are looking for an experienced professional in the area of drug product development for Gene Therapy-based drug products, with special focus on viral vectors. As a member of Pharmaceutical Development in the Cell and Gene Therapy Development Unit, Technical Development NBEs, you will play a key role in the development of parenteral dosage forms of viral and non-viral vectors, for gene therapy, for preclinical and clinical studies, as well as in the development of market formulations.

Job Purpose:

The Senior Principal Training Operations and Process Improvement Lead leads quality deliverables across platforms, franchises or therapeutic areas. Drives participation and inputs within Data Operations (DO), and cross functionality where applicable, in the delivery of quality data and programs, processes and documentation which satisfies regulations and aligns with industry standard methodologies for Data Management and Statistical Programming (Data Operations).

Your key responsibilities:
Your responsibilities include, but not limited to:

• Plan, lead and implement DO Process Standards and Control (PSC) across platforms, franchises or therapeutic areas. Accountable for all quality related aspects within remit to ensure full compliance to all applicable global regulatory requirements is maintained and business objectives are achieved.

• Leads discussions with internal team members and partners across and outside GDD in support of quality deliverables. Leads DO and PSC towards agreed deliverables, proactively addressing potential issues before they become problematic.

• Represents DO in all audits and inspections, centralizing and aligning the team in audit preparation, readiness and response.

• Actively participate in PSC Team and partners with organization to progress DO towards industry standard methodologies, simplification, agility and deliverable effectiveness.

• Manages and measures quality within platform, franchise or therapeutic area. Build and maintain strong partnerships within GDD with special focus within Data Management, Statistical Programming, Statistics, Clinical and Quality functions.

• Lead/participate and keep current in Industry regulations and requirements. Ensure Novartis participation in industry regulation initiatives (i.e., ICH, GCP, etc.).

• Ensures DO at Novartis is considered as industry leading internally and externally.

Diversity & Inclusion / EEO

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

Minimum Requirements

What you’ll bring to the role:

Key Performance Indicators:

1. Achieve overall goals as set each year by Global Head Data Operations, GDO. Achieve high level of quality, timeliness and customer satisfaction across Quality and Compliance activities, deliverables and support.

2. No critical findings as result of internal inspection, routine audits or health authority inspections relating to activities/deliverables supported by DO.

3. Effectiveness of participation in internal and external networks/initiatives.

Minimum/desirable:


Bachelor’s degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent. Preferred Post-graduate university or college degree recommended in Life Sciences, Computer Science, Medical Informatics or equivalent.

Languages: Fluent English (oral and written).

Experience/Professional requirement:

• Significant experience and knowledge in the Pharmaceutical or Device Industry.

• Expert in regard to regulatory requirements relevant to Data Management and Statistical Programming (e.g., GCP, ICH).

• At least 9 years of experience in global drug development, within the pharmaceutical or device industry.

• Superior interpersonal and communication skills. Builds positive departmental and inter-departmental relationships.

• Outstanding verbal and written skills.

• Proven track record to proactively identify issues, recommend and implement solutions.
Global Drug Development
GDO GDD
India
Hyderabad, AP
Research & Development
Full Time
Regular
No
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345364BR

Sr. Principal Process & Training Lead

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