Summary
Location: Durhan, NC #LI-Onsite
Shift: This is an evening shift position (3:00pm-11:30pm) This role is based 100% on-site.
About the Role
Key Responsibilities:
- Plan/schedule, execute, supervise, and review in-process, development, validation, and release testing on samples while working with cross-functional stakeholders to meet company quality standards and timelines.
- Support and manage tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality, assay performance and efficiency.
- Author, review, and approve Quality documents (i.e., protocols, reports, SOPs, test methods, technical documents, and risk assessments)
- Contribute, support, and lead writing of OOS/OOE/OOT and deviation investigations. Drive CAPA outcomes.
- Support internal and external audits.
- Assists in the evaluation of internal controls, communications, risk assessments and maintenance of documentation as related to compliance with internal and external safety, quality, and regulatory standards.
- Trains and educates employees and promotes adherence to quality control procedures, policies, standards, and best practices to foster a culture of quality awareness and accountability.
- Analyze quality data and metrics to identify trends, patterns, and areas of improvement.
- Promote a culture of continuous improvement, fostering innovation, and implementing Lean techniques to optimize quality control processes and enhance overall operational efficiency.
- Play a key role in the development and growth of direct reports, providing guidance, coaching, and support to enhance their performance and career progression within the organization.
Essential Requirements:
- Bachelor's degree in scientific disciplines such as Biochemistry, Biology or related field
- 5 years of experience in pharmaceutical industry or equivalent industry experience
- Proven experience as a quality control supervisor or similar leadership role within a quality laboratory environment
- Extensive knowledge of GLP and GDP principles. Understanding of quality management systems (QMS), regulatory requirements (FDA/EMEA), and industry standards.
- Possess a strong understanding of QC testing methods, tools, and techniques.
- Strong analytical and problem-solving skills, with the ability to make data-driven decisions and implement effective solutions.
- Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams and effectively communicate quality requirements and findings.
- Experience with leading/supervising people preferred
- Detail-oriented and organized, with the ability to manage multiple priorities and meet deadlines
The salary for this position is expected to range between $85,400.00 - $158,600.00/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
Why Novartis: 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. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
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 & 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.