Supervisor, Quality Control, Nights

4 weeks ago

Durham, United States Novartis Full time

**Summary**:
In this people management role, the Quality Control Supervisor will coordinate sample throughput and compliance activities within the Quality department as well as support development, validation, and external activities as needed. This is a night shift position (3:00pm-11:30pm)

**About the Role**:
Are you looking for an exceptional opportunity to showcase your expertise in quality control? Novartis Ag, a world-class pharmaceutical company, is seeking a highly skilled and ambitious Supervisor, Quality Control to join our dynamic team. As a leader in the industry, we are committed to delivering flawless products that positively impact the lives of patients worldwide. This is your chance to be part of a team that strives for excellence and actively contributes to improving global healthcare.

**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.
- 2. Support and manage tracking and trending systems, and programs which assist in the testing, evaluation and monitoring of quality, assay performance and efficiency.
- 3. Author, review, and approve Quality documents (i.e., protocols, reports, SOPs, test methods, technical documents, and risk assessments)
- 4. Contribute, support, and lead writing of OOS/OOE/OOT and deviation investigations. Drive CAPA outcomes.
- 5. Support internal and external audits.
- 6. 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.
- 7. 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.
- 8. Analyze quality data and metrics to identify trends, patterns, and areas of improvement.
- 9. Promote a culture of continuous improvement, fostering innovation, and implementing Lean techniques to optimize quality control processes and enhance overall operational efficiency.
- 10. 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.
- Role Requirements:
Role Requirements:

- 1. Bachelor's degree in scientific disciplines such as Biochemistry, Biology or related field with 5 years of experience in pharmaceutical industry or equivalent
- 2. Proven experience as a quality control supervisor or similar leadership role within a quality laboratory environment
- 3. Extensive knowledge of GLP and GDocP principles. Understanding of quality management systems (QMS), regulatory requirements (FDA/EMEA), and industry standards.
- 4. Possess a strong understanding of QC testing methods, tools, and techniques.
- 5. Strong analytical and problem-solving skills, with the ability to make data-driven decisions and implement effective solutions.
- 6. Excellent communication and interpersonal skills, with the ability to collaborate with cross-functional teams and effectively communicate quality requirements and findings.
- Detail-oriented and organized, with the ability to manage multiple priorities and meet deadlines.

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:
Novartis Ag is an equal opportunity employer (EOE) and is committed to providing reasonable accommodations/adjustments to individuals with disabilities. We value diversity and inclusion and believe that a diverse workforce fosters innovation and creativity. Join us in our mission to improve global healthcare and make a positive impact on patients' lives.

Division

Operations

Business Unit

Pharmaceuticals

Location

USA

Site

Durham

Company / Legal Entity

U473 (FCRS = US473) Novartis Gene Therapies

Functional Area

Quality

Job Type

Full time

Employment Type

Regular

Shift Work

No

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