Job Description Summary
At Novartis, we are pioneering the future of cancer treatment through Radioligand Therapy (RLT) - a powerful fusion of nuclear medicine and precision oncology. As we expand our global RLT manufacturing footprint, we are seeking passionate, purpose-driven individuals to join our mission of delivering life-changing therapies to patients around the world.The Global Head RLT QC / AS&T plays a crucial role in ensuring the quality and consistency of our products throughout their lifecycle. This role encompasses a wide range of responsibilities for the execution of strategy and the integration of all strategic and operational initiatives to ensure consistent and aligned standards across all laboratories, laboratory performance ("lean labs") and compliant analytical systems with competent and effective AS&T and QC organizations in the RLT Platform. Acting in accordance with legislation, internal regulations, good practices and business goals. It is a key leadership position as part of the RLT Quality leadership team working closely with Site QC heads as well as other platform QC / AS&T communities.
#LI-Remote
This position can be based remotely anywhere in the U.S. (there may be some restrictions based on legal entity). Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and/or international) will be defined by the hiring manager. This position will require 25% travel.
Job Description
Key Responsibilities:
- Leading the implementation of a QC strategy, including method lifecycle strategy, global laboratory digital strategy, new method strategy, to increase the compliance and efficiency of QC laboratories in the RLT organization.
- Enforcing global standardization/integration of business processes and information, data, global equipment standards and application architecture.
- Defining and enforcing current standards, procedures and quality module and directives, global SOPs for analytical laboratories, compliant with cGMP. Maintaining awareness of regulatory requirements affecting the pharmaceutical industry.
- Participation in the preparation for key inspections and, if necessary, support during the inspection.
- Enforcing the QC/AS&T action plan by defining and implementing appropriate roadmaps for QC/AS&T teams across the platform, ensuring compliance, continuous improvement and increasing the effectiveness of all types of QC testing. Initiating, implementing and sustaining initiatives defined by global QC/AS&T.
- Ensuring and promoting cross-site collaboration and transparency of joint initiatives, problems and lessons learned.
- Evaluating and deploying new technologies, systems and software that have the potential to improve the quality of existing QC testing strategies and/or increase laboratory productivity. Continued initiatives to modernize testing functions.
- Supporting the development of on-site platform/team members in technical and leadership skills. Coaching and people development. Delivering training programs developed by the global QC/AS&T function and actively participating in the development of relevant learning materials.
- Implementation and compliance with all instructions and requirements to ensure safe work, protection of the environment and property.
- Representing the company's vision, values and caring for good mutual relations with business partners.
Essential Requirements:
- University degree in Pharmacy, Chemistry, Biology or related subject; higher level degree preferred but not required.
- 10+ years’ experience in GMP-regulated industries including QA/QC in Biotech area.
- Working knowledge of FDA/EMA/ICH regulatory requirements
- Broad cGMP experience with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
- Ability to synthesize detailed information and provide clear communication and messaging across quality, manufacturing and supply chain.
- Approximately 25% travel required.
The pay range for this position at commencement of employment is expected to be between $168,000 and $312,000 per year; however, while salary ranges are effective from 1/1/25 through 12/31/25 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.
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, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
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 to perform the essential functions of a position, please send an e-mail to [email protected] or 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.
Salary Range
$168,000.00 - $312,000.00
Skills Desired
Agility, Agility, Audit Management, Business Acumen, Business Partnering, Business Strategy, Continued Learning, Dealing With Ambiguity, Employee Performance Evaluations, Finance Acumen, Health Authorities, Knowledge Of Gmp, Laboratory Excellence , Leadership, Manufacturing Production, Organizational Savvy, People Management, Product Release, Qa (Quality Assurance), Quality Control, Quality Management, Quality Management Systems (QMS), Root Cause Analysis (RCA), Self-Awareness, Six Sigma {+ 4 more}
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