Novartis Hiring for Senior Quality Assurance Engineer Lead job in Indianapolis Full Time

About the role
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 experienced Engineering professionals to help us reach our ambitious goals.

The Sr. Quality Assurance Engineer Lead is responsible for the design, construction, validation, maintenance and overall compliance of facilities, systems and processes at the Indianapolis radioligand manufacturing site.

Responsibilities include but not limited to:

• Provides strategic quality input on the translation of commercial product requirements into technical solutions that are capable of meeting defined CQAs (product Critical Quality Attributes) and CPPs (Critical Process Parameters).

• Provides oversight of the Computerized System Validation Lifecycle efforts to ensure compliance with 21 CFR Part 11, EudraLex Annex 11, and applicable FDA/EMA Guidance’s on electronic data integrity Contributes to design of facility, utilities and process equipment from a Quality and Compliance perspective.

• Provide Quality oversight, review, and approve Validation Documentation including but not limited to: Validation Master Plan, User Requirements, Functional Requirements, Installation Qualification, Operational Qualification, Performance Qualification, Trace Matrix, Validation Summary Reports, and Change Controls.

• Supports the Qualification and Validation activities in relation to QC and manufacturing equipment, utility and facility design.

• Review and approve periodic review documentation for qualified equipment/systems (audit trails, user groups, system administration)

• Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place

Commitment to Diversity & Inclusion:
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 [email protected] or call +1 (877)395-2339
• Sandoz: e-mail [email protected] or call: +1-609-422-4098

Role Requirements
What you will bring to the role:

B.S. degree, preferably in engineering, chemistry or biochemistry.

Experience:

• 8+ years of experience in a GxP pharmaceutical manufacturing operations
• 2+ years of experience in a quality assurance role
• Strong knowledge and application of the CFR’s and cGMP’s and have been involved in regulatory inspections.
• Comprehensive knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
• Direct experience with commissioning, qualification and validation to meet FDA and other health authority requirements.
• Experience with deviations, CAPAs, and Change Controls.
• Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations.
• Experience leading people
• Excellent oral and written communication skills with strong technical writing experience required.
• Experience leading internal audits, identify findings, drive resolution and provide closure report is desired.
• Ability to synthesize data and summarize outcomes to provide recommendations on compliant path forward.
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.

Why 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:
https://www.novartis.com/about/strategy/people-and-culture

The pay range for this position at commencement of employment is expected to be between $112,800 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 the Novartis Life Handbook: https://www.novartis.com/careers/benefits-rewards

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 [email protected] 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.

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: https://talentnetwork.novartis.com/network