Senior QA Compliance Specialist

Overview

Senior QA Compliance Specialist role at Novartis
. This is a temporary contractor opportunity through Magnit Global.

Base pay range: $66.73/hr
.

Location:

Indianapolis, IN (Onsite preferred, remote considered in ET Zone/USA Only).

Contract:

6-month | Pay rate: $48.60 - $66.73/hr based on experience and qualifications (W2 Only).

The QA Compliance Specialist implements robust Quality Systems for the RLT Indianapolis site, considering Novartis and regulatory requirements. This role contributes to the execution of these systems, authors or contributes to the procedures governing these systems, and supports timely implementation. Experience in Quality Management Review, Self-Inspection, training, and execution of health authority inspections is required.

• Supports the development and oversight of robust quality systems, including both implementation and operation at site level.
• Leads the site level Quality Management Review (QMR) 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.
• Facilitates training on all QA Compliance programs.
• Supports management to implement and maintain the following programs:
  Training and Qualification, Quality Management Review (KPIs), Annual Product Quality Review (APQR), Compliance Alerts, Market Actions and Novartis Global document assessments required to be performed at the site level.
• Contributes to site inspection preparation, program management, response and commitment process.
• Escalates high quality risks per procedure and supports agency notifications such as Field Alerts.
• Performs duties to ensure compliance with global and local regulations.
• Represents QA Compliance on project teams and in meetings.
• Supports continuous improvement and oversight of QA Compliance programs and identifies and implements new technologies to improve compliance and efficiency of QS operations.
• Adheres to all GMP requirements.
• Other related duties as assigned.

• 8+ years of experience in a GMP Biopharmaceutical environment
• 2+ years of experience in a Quality Assurance role
• Experience reviewing systems and analyzing data (paper or electronic) to identify specific compliance and data consistency issues.
• Previous Quality Assurance experience required, including Data Integrity (ALCOA+) compliance.
• Previous experience in QA Compliance including self-inspections, preferred.
• Ability to apply a phase appropriate, risk-based approach to QA operational decisions.
• Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
• Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines; experience in US and international regulatory agency inspections a plus.
• Proficient in using Microsoft Word, Excel, PowerPoint.
• Strong follow-up and organizational skills.
• Experience with radiopharmaceutical therapies a plus.
• Direct experience reviewing and/or authoring standard operating procedures.
• Ability to work well independently and within a team.
• Excellent oral and written communication skills with technical writing experience required.

B.S. degree, preferably in Life Sciences, chemistry or related relevant degree.

Location:

Indianapolis, IN (Onsite Preferred, but remote considered working ET Zone/USA Only)

Health, dental, vision, 401k

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 to achieve breakthroughs that change patients’ lives.

The Novartis Group of Companies are Equal Opportunity Employers. 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.

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 directs