Novartis Hiring for Quality Systems and Compliance Head job in Indianapolis Full Time

236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying.
Imagine what you could do here at Novartis!

The Quality Systems and Compliance Head, provides critical quality and compliance expertise for designing and implementing robust Quality Systems for the AAA Indianapolis site considering current GMP regulations and procedures.

Responsibilities include but not limited to:
• Provide daily leadership and management for the Quality Systems and Compliance teams.
• Provides oversight in the management of health authority inspections and site risk management.
• Provide quality input on the design and architecture of Quality Systems.
• Makes quality decisions and address or resolve issues based on experience, written procedures, and analysis.
• Provides oversight for the implementation of Quality Systems and Regulatory Compliance including management of Nonconformances, CAPAs, Effectiveness Checks, Change Controls, Document Control, Training, Inspections and Audit readiness, technical complaints, Risk Assessments and remediation, Supplier Quality Management, Annual Product Quality review, self-assessments, KPIs and Quality Management Reviews.
• Designs strategic site quality system and works in collaboration with Manufacturing Operations to authorize written procedures including but not limited to monitor and control of the manufacturing environment, training, document control/record retention, deviations/CAPA investigations, and monitoring compliance with all requirements of good manufacturing practice.
• Develops quality related business systems such as deviation, CAPA, OOS, product complaints and facility wide GMP training and provide critical quality expertise to transition novel gene therapies into commercially approved products.
• Develops and delivers a robust overall quality system, strategy, and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes.

The pay range for this position at commencement of employment is expected to be between $144,000 and $216,000 per year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. 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.Education: B.S. degree preferably in biology or microbiology, chemistry, biochemistry or related discipline

Language: Fluent English

Experience: 10 years of related experience working in a regulated industry with 7 years of experience in pharmaceutical / biotech / biopharma GMP operations or an equivalent education and work experience combination.

• 7 years’ experience in supervision of teams and processes is preferred, including training the team and providing continued guidance, mentorship and support.
• Strong knowledge in Quality Systems selection and application of the CFRs and cGMPs and ability to provide oversight for the architecture and global implementation of these systems, including procedures governing these systems.
• Comprehensive knowledge of regulations (e.g., FDA, EMA) and experience in US and international regulatory agency inspections.
• Direct experience reviewing and/or authoring policies, standard operating procedures, and partnering with operations on product related investigations and deviations.
• Strong knowledge and application of the CFRs and cGMPs and involvement in multiple regulatory inspections (familiar with multiple regulatory jurisdictions both domestically and international).
• Excellent oral and written communication skills with strong technical writing experience.
• Experience leading both internal and external vendor audits, identifying findings, driving resolution and providing closure report.
• Ability to analyze data and summarize outcomes to provide recommendations on a compliant path forward.
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence.
• Experience with radiopharmaceuticals is a plus.

Why Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer. How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity, and inclusion. 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:
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.