- Contributes to the design architecture of Quality Compliance by authoring or providing robust compliance feedback to the procedures governing the site compliance programs and working with other functional departments towards their timely implementation.
- Supports the site level Quality Management Review program including monitoring and reporting key performance indicators, as appropriate.
- Works with the management team to implement and execute the Inspection Readiness program, including Novartis Corporate Inspections and Global Health Authority Inspections.
- Supports quality inspections at the site level.
- Monitors industry observations and trends as a preventive tool to ensure compliance.
- Develops internal audit schedule and lead internal audit performance, follow up, and escalation of significant observations.
- Supports management to implement and maintain the following programs: Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments
- Leads and prioritize on-going continuous improvement projects directly related to Quality Compliance to support business needs.
- Reviews and approve global change controls, deviations and CAPA and perform effectiveness checks.
- Acts as representative in monthly Quality Management Review meeting (QMR) to review plant metrics, ensure a state of control and drive action where appropriate along with reporting on a specific set of quality and compliance metrics.
- BS in Life Sciences or other relevant scientific field with minimum of 6 years' experience within a regulatory or pharmaceutical environment. Master's a plus.
- Comprehensive knowledge and understanding of FDA, ICH, EU, and Health Canada regulatory compliance requirements, guidelines, standards, and expectations.
- Direct experience reviewing and/or authoring global policies and standard operating procedures.
- Experience with system selection and/or global implementation of QMS
-
Compliance Program Oversight Lead
1 day ago
Stripe Indianapolis, United StatesStripe is a financial infrastructure platform for businesses. Millions of companies—from the world's largest enterprises to the most ambitious startups—use Stripe to accept payments, grow their revenue, and accelerate new business opportunities. Our mission is to increase the GDP ...
-
Records and Compliance Coordinator, Lead
1 week ago
Republic Airways Indianapolis, United StatesRecords and Compliance Coordinator, Lead · in · Indianapolis , · Indiana · Job Category: · Quality · POSITION PURPOSE · Maintains and retains maintenance, repair, overhaul and inspection records in accordance with the requirements of 14 Code of Federal Regulations · ESSENTIA ...
-
Records and Compliance Coordinator, Lead
1 week ago
Republic Airways Indianapolis, United StatesRecords and Compliance Coordinator, Lead in Indianapolis , Indiana Job Category:QualityPOSITION PURPOSEMaintains and retains maintenance, repair, overhaul and inspection records in accordance with the requirements of 14 Code of Federal Regulations ESSENTIAL DUTIESTo perform this ...
-
Records and Compliance Coordinator, Lead
1 week ago
Republic Airways Indianapolis, United StatesJob Category: · Quality · POSITION PURPOSE · Maintains and retains maintenance, repair, overhaul and inspection records in accordance with the requirements of 14 Code of Federal Regulations · ESSENTIAL DUTIES · To perform this job successfully, an individual must be able to ...
-
QA & Compliance, Test Automation Specialist/Lead
3 weeks ago
Alight Indianapolis, United StatesAlight · QA & Compliance, Test Automation Specialist/Lead · TG , · Indiana · Apply Now · At Alight, we believe a company's success starts with its people. It's why we're so driven to connect passion with purpose. Our team's expertise in human insights and cloud technology, a ...
-
Laguna Source Indianapolis, United StatesThis is an exciting opportunity to join a leading food manufacturing company that produces and distributes low-calorie nutritional products as well as innovative powders and low acid aseptic beverages targeting consumers who seek healthier alternatives. Your overall responsibilit ...
-
Quality Assurance Compliance Specialist
2 days ago
SPECTRAFORCE Indianapolis, United StatesJob title: QA Compliance Specialist · Location: Indianapolis, IN · Duration: 6 months · This position's starting pay is: $58.00/hr. · Summary: · The QA Compliance Specialist implements robust Quality Systems for AAA Indianapolis considering client and regulatory requirements of t ...
-
Senior Auditor
4 days ago
Elsdon Technology Indianapolis, United StatesCapable of identifying issues during the audit process and determining how to address them in the audited financial statements. · Can discern whether a matter is a finding or an item for communication with governance, with some guidance from the team lead. · Skilled in consisten ...
-
Analyst, NERC Compliance, RF Region
2 weeks ago
The AES Corporation Indianapolis, United StatesAES Indiana NERC Operations Compliance · Senior NERC Compliance Engineer to support AES Indiana NERC programs with Generation and T&D experience. Under limited supervision, this role is primarily responsible for carrying out individual work assignments concerning developing and i ...
-
Compliance Specialist
1 day ago
Randstad Life Sciences US Indianapolis, United StatesThe company's purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as m ...
-
Quality Manager
3 weeks ago
LHH Indianapolis, United StatesLHH is seeking a Quality Manager for a Direct Hire, Permanent Placement position with an aerospace and defense manufacturing client located in Indianapolis, Indiana. This is a unique opportunity to join a well-established organization that is known for consistently achieving high ...
-
Human Resources Director
4 days ago
Ferretti Search Indianapolis, United StatesWe have been a domestic manufacturer for over 60 years and are currently driving an exciting period of company evolution. As we continue to expand and improve our operations, we are seeking an experienced Human Resources Manager/Director to join our team and drive success across ...
-
Production Supervisor
4 days ago
First Search Inc. Indianapolis, United StatesOur colleagues client is a global manufacturing group with a reputation for having the highest Quality standards. We are currently seeking two key individuals to direct the production efforts within our very high speed manufacturing facility. As a Production Supervisor you will l ...
-
Quality Assurance Manager
4 days ago
Pedagog Recruiting & Careers Indianapolis, United StatesPurpose: The Quality Assurance Manager ensures regulatory compliance, best-in-class quality practices, and supports growth. This role manages cGMP manufacturing, packaging, testing, and storage activities and participates in relevant audits. Collaborates with various departments ...
-
Sterility Assurance Specialist
1 day ago
Astrix Indianapolis, United StatesLeading Biotech Research company is searching for a Sterility Assurance Specialist to join their team to support scientific research performed as part of preclinical Research and Development. · Type: Contract to hire (6 month) · Schedule: 1st shift Monday-Friday (9a-5p) · Pay: $3 ...
-
Quality Assurance Specialist
5 days ago
RayzeBio Indianapolis, United StatesJob Title: Quality Assurance Specialist · Location: Indianapolis · NH#: 38 · Background · RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the compan ...
-
Data Governance Analyst
3 weeks ago
Insight Global Indianapolis, United StatesDescription: · Insight Global is seeking a highly skilled and motivated Data Governance Specialist to join their team in Indianapolis. This candidate will need to possess a proven background in data governance frameworks and strategies, which include metadata management, data cat ...
-
Health And Safety Manager
5 days ago
ERM Indianapolis, United StatesERM is hiring a Health & Safety Manager in Indianapolis, IN. In this critical role, you will be responsible for establishing, implementing, managing and continuously improving the environment, health and safety programs for the facility. The H&S Manager will have broad knowledge ...
-
Quality Assurance Specialist
4 days ago
RayzeBio Indianapolis, United StatesJob Title: Quality Assurance Specialist · Location: Indianapolis · NH#: 38 · Background · RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the compan ...
-
Purchasing Manager
4 days ago
AmeriFab, Inc Indianapolis, United StatesManufacturing Purchasing Manager · Position Overview: · The Manufacturing Purchasing Manager is responsible for overseeing the procurement of raw materials, equipment, and supplies necessary for steel mill equipment manufacturing operations. This role involves negotiating contrac ...
Quality Compliance Lead - Indianapolis, United States - Novartis Farmacéutica
Description
At Advanced Accelerator Applications, a Novartis company, we are committed to leading innovation in nuclear medicine and delivering the next generation of targeted radioligand therapy to cancer patients.
The Quality Compliance Lead will provide regulatory compliance awareness, education, and guidance to the different functional areas on how to interpret, understand and comply with the regulation requirements and expectations including GMP and industry practices.
In this role you will be responsible for overseeing and supporting the Inspection Audit Program, Customer Complaint Reporting, Supplier Qualification Program, Annual Product Quality Review, Health Authority Notifications & Market Actions, and Escalation Management.
Your responsibilities include, but are not limited to:We 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.
Accessibility and Reasonable Accommodations:
Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:
Novartis:
e-mail or call
Sandoz:
e-mail or call:
Role Requirements
Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world.
How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions.Be a part of this mission and join us Learn more here:
The pay range for this position at commencement of employment is expected to be between $112,800.00 and $169,200 per year; however, while salary ranges are effective from 1/1/23 through 12/31/23 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 can find everything you need to know about our benefits and rewards in theNovartis Life Handbook:
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 call and let us know the nature of your request and your contact information.
Please include the job requisition number in your message.Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
Why
Novartis:
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?
Join our Novartis Network:
Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up:
#J-18808-Ljbffr
