What are the responsibilities and job description for the Senior Director of Quality position at HireNetworks?
Senior Director of Quality
The Senior Director of Quality will lead the company’s quality organization, providing both technical and managerial leadership across all levels of the team. This role is responsible for overseeing quality initiatives, ensuring compliance, and supporting clients in the biopharma, biotech, and drug/device combination product space. Key responsibilities include implementing quality systems, supporting regulatory inspections (e.g., FDA, EMA), managing an electronic Quality Management System (eQMS), and driving strategic initiatives. The role combines high-level planning, client engagement, and hands-on quality oversight.
The Senior Director of Quality is a full time position based in Morrisville, NC, offering a competitive base salary and bonus. Candidates must have a passport and will travel up to 25%. There are no sponsorship or third party arrangements for this role.
Responsibilities:
- Provide technical leadership to project teams, ensuring successful execution and client satisfaction.
- Plan and execute quality activities, delegate tasks, and monitor progress.
- Support business development through presentations, public speaking, and industry contributions.
- Mentor and develop the quality team, including performance reviews and resource management.
- Identify risks, enforce quality standards, and educate clients on compliance boundaries.
- Improve internal processes and align strategies with future business needs.
- Conduct technical reviews of quality documents and submissions.
- Lead audits, compliance efforts, and quality system remediation for clients.
- Guide clients in preparing for regulatory submissions and inspections.
- Serve as the company’s Management Representative for quality oversight.
Experience & Qualifications:
- Bachelor’s degree in engineering or science (advanced degree preferred).
- 15 years of quality, compliance, and operations experience in medical device, pharmaceutical, or combination products industries.
- 8 years in a leadership role.
- Certified Quality Auditor (CQA).
- Proven expertise in regulatory submissions (e.g., IND, NDA, BLA, 510(k), PMA).
- In-depth knowledge of FDA, ISO, ICH guidelines, design controls, and risk management standards.
- This role requires a strategic thinker with extensive industry experience, leadership skills, and a proven track record of driving quality excellence and compliance.
Contact Judy Protz at jprotz@hirenetworks.com with questions regarding this posting. A Word resume is preferred when applying.
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