Director of Quality
Proclinical Group, Manchester, NH, 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.
Proclinical 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.
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.
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- 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.
Proclinical 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.
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.
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