I'm looking for Senior Director of Quality roles in Warren, NJ, with a focus on biotech or pharma industries. I have over 10 years of experience, and I prefer full-time positions that offer a salary starting at $185,000.

Okay, I've searched for Senior Director of Quality roles in Warren, NJ specifically in the biotech or pharma industries. Based on your experience of over 10 years and your salary expectation starting at $185,000, I have found 12 positions that match your criteria. You can review them now.

Senior Director Quality

Warren, NJ

Biotech

10 years + Experience

$185000+

Can you help me to analyze the job description and company culture?

Sure. Here's the analysis:

Job Analysis:

The Senior Director of Quality at DBV Technologies is fundamentally tasked with ensuring the quality and regulatory compliance of innovative immunotherapy products throughout their lifecycle. This role demands a strategic partnership with the VP of Quality, with responsibilities that extend from regulatory oversight to quality improvement initiatives and stakeholder management. The candidate will need to navigate complex regulatory landscapes, author and review critical regulatory documents, and represent DBV in health authority interactions, all while managing high-priority projects that align with the company's mission to advance treatments for food allergies. Success in this role entails not only a solid foundation in GxP practices and project management but also the ability to foster collaboration across departments and drive a culture of continuous improvement. The candidate will likely face challenges related to meeting stringent regulatory requirements and ensuring operational excellence amidst a rapidly evolving industry landscape.

Company Analysis:

DBV Technologies operates within the biopharmaceutical sector, focusing specifically on developing innovative immunotherapies for severe food allergies and autoimmune diseases. As a clinical-stage company founded by pediatricians, its mission emphasizes patient care and addressing unmet medical needs, positioning it as both a pioneer and a key player in this niche market. The company culture appears to prioritize innovation, collaboration, and ethical responsibility, which are vital for navigating the regulatory complexities inherent to biopharma. With the Senior Director of Quality playing a critical role in upholding these standards and ensuring compliance, the position likely carries significant visibility within the organization and the industry. The Senior Director will not only contribute to immediate operational goals but also support longer-term strategic objectives, particularly as the company seeks to be at the forefront of epicutaneous immunotherapy. This indicates that the role is essential for scaling the organization’s efforts and maintaining its reputation in a competitive field, suggesting high expectations for leadership and strategic impact.

Mock up some interview questions based on the job description.

Absolutely. Here are some mock interview questions that could come up:

Tell me about a time when you had to lead a major quality initiative. What challenges did you face, and how did you overcome them?
Can you provide an example of how you've managed cross-functional teams in previous roles? What was the result?
Describe a situation where you had to influence stakeholders at different levels of the organization. How did you approach that?
How do you handle unexpected regulatory challenges when they arise during a project?
What is your approach to maintaining compliance with multiple regulatory authorities, such as the FDA or EMA?
How have you implemented continuous improvement methodologies in a previous role, and what was the impact?
Imagine you are preparing for a regulatory submission and discover a significant issue. What steps would you take to address it?
If you were to identify a potential risk in a project, what process would you follow to develop a mitigation plan?
What attracts you to work with DBV Technologies specifically, and how do you see your experience aligning with our mission?
How do you stay updated on regulatory requirements and best practices in the biopharma industry?
What strategies do you use to keep your teams motivated, especially during high-pressure projects?
Could you explain how you would approach developing quality metrics and KPIs for a new product?
How do you envision your leadership style contributing to the culture of quality at DBV Technologies?
What questions do you have about our current quality initiatives or regulatory processes?
In what ways do you believe your previous experiences have prepared you for a role focused on innovative therapies like epicutaneous immunotherapy?

Job Details

Overview Company

Senior Director Quality

$185k/y-$215k/y

DBV Technologies

2 months ago

Highlight

HybridFull-timeDirector

Summary

DBV Technologies is seeking a Senior Director Quality to join their team in Warren, NJ. The role involves serving as a trusted advisor and strategic partner to the VP, managing day-to-day operations, and ensuring regulatory compliance.

About the Role

As a Senior Director Quality, you will partner with the VP of Quality to plan, coordinate, and track strategic initiatives across the Quality function. You will support regulatory submissions, manage commercial product specifications, and oversee quality improvement initiatives. You will also represent the VP in meetings, manage high-priority projects, and ensure compliance with regulatory requirements.

About You

Required:

BS/MS in life sciences, advanced degree a plus.
Minimum of years of experience in biotech/pharma quality roles, with solid cross-functional GxP knowledge.
Strong project management skills with a track record of successfully delivering projects on time and within budget.
Experience supporting or leading interactions with health authorities (e.g., FDA, EMA).
In-depth knowledge of quality management systems, regulatory requirements, and industry best practices.
Excellent problem-solving and analytical skills.
Exceptional communication and interpersonal skills.

Preferred:

Curiosity: Demonstrated desire to learn, explore, and understand new things.
Courage: Ability to confront fear, uncertainty, and challenges with confidence and resolve.
Collaboration: Working with others to achieve a common goal.
Credibility: Builds trust, is reliable, acts with ethics and integrity.

DBV Technologies

DBV Technologies is a global clinical stage biopharmaceutical company founded by pediatricians who believed that food allergies could one day be treated safely and effectively.

We are on a mission to advance epicutaneous immunotherapy using our innovative technology platform, Viaskin™, to develop treatment options for immunologic diseases with significant unmet medical need.

This mission drives our commitment to the advancement of treatments for patients and their families. That is why we are investigating a potential new class of immunotherapy, epicutaneous immunotherapy (EPIT), that aims to re-educate the immune system of patients through the skin.

Today, we are focused on exploring the use of Viaskin to address food allergies, a devastating condition that afflicts millions of patients. As an important milestone in our journey, we hope to offer the first epicutaneous immunotherapy treatment for peanut allergy.

Tomorrow, as pioneers, we will continue to explore the broad applications of this potential new class of immunotherapy, including treatments for patients suffering from inflammatory and autoimmune diseases.

Warren, NJ