QA Compliance Specialist
QA Compliance Specialist
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$ 92800 - 139200
1 Vacancy
Job Description
Band
Level 3Job Description Summary
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. We are looking for an experienced Compliance Specialist with previous experience in a GMP Biopharmaceutical environment to help us reach our ambitious goals.As a Compliance Specialist you will be responsible for implementing robust Quality Systems at our new Radioligand Therapy (RLT) Isotope Manufacturing site in Indianapolis incorporating Novartis and regulatory requirements. You will contribute significantly to the of these systems author or contribute to the procedures governing these systems and work towards timely implementation. You will participate in Quality Management Reviews SelfInspections trainings and in health authority inspections.
Job Description
Key responsibilities:
- Support the development and oversight of robust quality systems at site level including both implementation and operation.
- Lead the site level Quality Management Review (QMR) program including monitoring and reporting key performance indicators.
- Work with the management team to implement and execute the Inspection Readiness program including Novartis Corporate Inspections and Global Health Authority Inspections.
- Facilitate training on all QA Compliance programs.
- Support management in implementing and maintaining 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 at the site level.
- Escalate high quality risks per procedure and support agency notifications such as Field Alerts.
- Support the continuous improvement and oversight of QA Compliance programs. Identify and implement new technologies to improve the compliance and efficiency of QS operations.
- Represent QA Compliance on project teams and in meetings.
Essential Requirements:
- B.S. degree preferably in Life Sciences chemistry or related relevant degree.
- 6 years of experience in a GMP Biopharmaceutical environment including at least 2 years of experience in a Quality Assurance role. QA experience must include Data Integrity (ALCOA) compliance.
- Experience supporting cGMP manufacturing operations through administration and enforcement of the Quality Management System.
- Working knowledge of cGMP/ICH/FDA/EU regulations and guidelines and experience in US and international regulatory agency inspections a plus.
- Excellent oral and written communication skills and technical writing experience.
- Proficient in using Microsoft applications (MS Word MS Excel MS PowerPoint).
- Experience reviewing systems and analyzing data to identify specific compliance and data consistency issues. Experience reviewing and/or authoring standard operating procedures.
- Ability to apply a phase appropriate riskbased approach to QA operational decisions.
Desirable Requirements:
- Experience with radiopharmaceutical therapies
- Previous experience in QA Compliance including selfinspections
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The pay range for this position at commencement of employment is expected to be between $92800 and $139200 per year; however while salary ranges are effective from 1/1/24 through 12/31/24 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 signon 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 atwill 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.
EEO Statement:
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 gender national origin age sexual orientation gender identity or expression marital or veteran status disability or any other legally protected status. 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
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 email to calland let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Range
Skills Desired
ActionOriented Compliance Requirements Continued Learning Dealing With Ambiguity Functional Skills Gmp Procedures Gxp Industry Standards Process Optimization Qa (Quality Assurance) Quality Standards SelfAwareness Technological Expertise Technological IntelligenceRequired Experience:
Unclear Seniority
Employment Type
Remote
