QA MD Operations & Project Expert

To be considered for the QA MD Operations & Project Expert position at Novartis, candidates should hold a university degree in Engineering, Pharmacy, Biochemistry, Biotechnology, Chemistry, or Microbiology. Additionally, at least three years of experience within the medical device industry, particularly in QA, MS&T, or QC roles, is essential. Familiarity with third-party management and a thorough understanding of cGMP and quality assurance processes are also crucial.

The QA MD Operations & Project Expert at Novartis is responsible for ensuring quality throughout the commercialization of new autoinjector devices. Key duties include managing third-party suppliers, implementing changes related to materials, and overseeing compliance with cGMP regulations. The expert will also review production and quality records and support investigations into any quality exceptions, ensuring that the products meet the highest standards.

Novartis is committed to ongoing professional growth for all employees, including those in the QA MD Operations & Project Expert role. Opportunities include access to a wide range of learning and development programs, participation in OpEx improvement projects, and the potential to advance across the global Novartis organization. Employees are encouraged to take advantage of their various career pathways and experiences.

The work environment for a QA MD Operations & Project Expert at Novartis is dynamic and fast-paced. This role involves collaboration with various departments and global suppliers, making it essential to adapt quickly to changes and thrive in a matrix environment. Novartis promotes flexibility, offering options for part-time work, job-sharing, and remote working when possible.

At Novartis, QA MD Operations & Project Experts can look forward to extensive growth opportunities. Beyond the immediate responsibilities of managing QA processes, employees can engage in cross-functional projects, participate in global initiatives, and enjoy the potential for upward mobility within the organization as they contribute to groundbreaking medical advancements.

To answer this question effectively, discuss specific projects where you successfully managed third-party suppliers, emphasizing your communication, negotiation skills, and ability to ensure compliance with quality standards. Highlight any specific tools or methodologies you utilized to track performance and maintain quality.

Detail your understanding of cGMP regulations and share examples from your past roles where you closely monitored compliance measures. Describe how you implemented quality control procedures and handled documentation for inspections and audits.

Provide a specific incident that demonstrates your problem-solving abilities. Outline the steps you took to analyze the issue, the stakeholders you involved, and what the outcome was. Stress the importance of documentation and follow-up in quality assurance.

Discuss methodologies such as risk assessment, performance metrics, or compliance checks that you utilize when evaluating changes. Emphasize the importance of thorough evaluations to prevent negative impacts on quality.

Describe your approach to conflict resolution, such as maintaining open communication, finding common ground, and documenting agreements. Sharing an example of a situation where you successfully resolved a conflict can strengthen your answer.

Mention resources such as industry publications, training sessions, and networking with professionals. Emphasize continuous learning as an essential habit to ensure compliance and stay informed on market best practices.

Be sure to reflect on Novartis’s mission and values, resonating with their commitment to improving patient lives. Share how your career goals align with the company’s objectives and express enthusiasm about contributing to the development of innovative medical devices.

Discuss methods like the Eisenhower Matrix or project management tools that allow you to prioritize effectively. Provide examples that showcase your organizational skills and ability to adapt under pressure.

Explain the assessment criteria you would apply, including compliance with specifications, efficacy, and safety measures. Discuss your experience evaluating Device History Files (DHF) and Device Master Records (DMR).

Clarify the significance of data integrity in establishing credibility within quality assurance. Discuss how you have implemented strategies to maintain data accuracy and reliability and prevented data tampering in your previous roles.