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Director of Quality
- Permanent
- Good Manufacturing Practice (GMP)
- United States
Director of Quality - Permanent - New Hampshire
Are you passionate about quality and precision? Join our client as Director of Quality and help ensure top-tier standards every day.
À±½·ÊÓÆµ is seeking a Director of Quality to lead quality governance, FDA regulatory compliance, and continuous improvement initiatives within a regulated manufacturing environment.
Primary Responsibilities:
This role will ensure alignment with compliance standards and operational goals. You will collaborate across departments to maintain regulatory readiness, drive process improvements, and uphold product quality standards.
Skills & Requirements:
- Bachelor's degree in Chemistry, Microbiology, Engineering, Pharmaceutical Sciences, or a comparable scientific or technical discipline.
- In-depth knowledge of FDA regulations for OTC drugs and cosmetics, including cGMP requirements and validation methodologies.
- Demonstrated success in leading FDA inspections and coordinating effective responses to regulatory findings.
- Excellent written and verbal communication skills, with the ability to engage confidently in audit-level discussions.
- Proven capability in maintaining, enhancing, and driving Quality Management Systems within a regulated setting.
- Hands-on experience with ERP/MRP platforms and electronic Quality Management Systems (eQMS).
- Strong collaborative approach combined with effective project management, analytical thinking, and budget oversight skills.
The Director of Quality's responsibilities will be:
- Provide leadership and oversight across Quality functions, including Quality Assurance, Quality Control, Validation, and FDA compliance.
- Design, implement, and sustain a robust, scalable Quality Management System (QMS).
- Ensure full compliance with FDA regulations, cGMP standards, and internal quality policies across manufacturing, packaging, warehousing, and supply chain activities.
- Collaborate with cross‑functional teams to embed quality systems and support regulatory submissions, audits, and certifications.
- Track, analyse, and report on key performance indicators (KPIs) covering batch release, deviation trends, CAPA effectiveness, audit readiness, and overall product quality.
- Act as the primary quality representative during FDA inspections and regulatory audits, including preparation of responses and corrective action plans.
- Oversee Quality frameworks for contract packagers and third‑party manufacturers to ensure compliance and performance accountability.
- Manage Quality Unit resource planning, headcount, and budgetary requirements.
- Champion environmentally responsible practices in alignment with organisational sustainability goals.
Compensation:
- $100,000 to $120,000 per annum.
If you are having difficulty in applying or if you have any questions, please contact Alex Bill at a.bill@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
À±½·ÊÓÆµ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. À±½·ÊÓÆµ is acting as an Employment Agency in relation to this vacancy.
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