Head of Quality
2 weeks ago
Head of Quality
Onsite in
Fairfield, NJ
We're seeking an experienced Head of Quality to oversee all Quality and Regulatory functions — ensuring compliance with FDA, cGMP, and global regulatory standards. This is a critical leadership role responsible for setting the company's quality vision, overseeing ANDA/NDA submissions, managing inspections, and leading both QA and QC operations.
What You'll Do
- Lead all aspects of Quality Assurance (QA), Quality Control (QC), and Quality Systems.
- Develop, implement, and maintain a comprehensive Quality Management System (QMS) aligned with FDA and global requirements.
- Oversee ANDA, NDA, and international regulatory submissions and lifecycle management.
- Ensure inspection readiness and lead FDA and internal audits.
- Direct CAPA, deviations, batch record review, and change control processes.
- Partner cross-functionally with Manufacturing, R&D, and Operations to embed quality across all functions.
- Provide strategic leadership on compliance, regulatory strategy, and continuous improvement.
- Represent Garonit Pharma in regulatory communications and inspections.
What You'll Bring
- Bachelor's or Master's degree in a scientific discipline (Pharmacy, Chemistry, Engineering, or Life Sciences).
- 15+ years of progressive experience in pharmaceutical Quality and Regulatory leadership.
- Proven expertise with cGMP, 21 CFR, ICH guidelines, and ANDA/NDA submissions.
- Demonstrated success leading quality organizations through audits, inspections, and product approvals.
- Excellent leadership, communication, and decision-making skills.
- Strategic thinker with meticulous attention to detail and a passion for quality excellence
Why Garonit Pharma
- Lead the quality and compliance strategy for a growing, innovation-driven pharma company.
- Build and shape the Quality organization
- Collaborate with experienced executives committed to scientific and operational excellence.
- Competitive executive compensation and growth potential in a high-impact leadership role.
-
Head of Quality
3 weeks ago
Fairfield, United States Garonit Pharmaceutical Full timeWe’re seeking an experienced Head of Quality to oversee all Quality and Regulatory functions — ensuring compliance with FDA, cGMP, and global regulatory standards. This is a critical leadership role responsible for setting the company’s quality vision, overseeing ANDA/NDA submissions, managing inspections, and leading both QA and QC operations. What...
-
Head Cook
2 weeks ago
Middletown, NJ, United States Spark Day Camp Full time $124,800 - $156,800 per yearResponsibilities: Organize and coordinate all aspects of the kitchen.Head Cook needed for large recreational facility in Middletown, NJ. Two full-sized ice rinks open year-round with successful hockey and skating programs. Three outdoor pools with pool club in the summer, and rapidly expanding day camp.Prepare and cook menu items according to recipes and...
-
Head Lifeguard
1 week ago
Fairfield, United States Central Connecticut Coast YMCA Full timeDescriptionThis position supports the mission and work of the Y, a leading nonprofit, charitable organization. The Head Lifeguard maintains a supportive, positive atmosphere that welcomes and respects all individuals. Providing lead supervision for Lifeguards, the Head Lifeguard assures the well-being for each participant in line with YMCA of the USA...
-
Head Lifeguard
1 week ago
Fairfield, United States Central Connecticut Coast YMCA Full timeDescriptionThe Fairfield Y is looking for a Head Lifeguard to join our team and help create a safe, welcoming, and engaging environment for our community. As a leader in our aquatics department, you will provide supervision for lifeguards, ensure compliance with safety regulations, and support high-quality, member-focused aquatic programs. This role requires...
-
Head of Professional Services
6 days ago
Wayne, NJ, United States Aptimized Full timeHead of Professional Services & Project Office Location: Wayne, NJ Employment Type: Full-Time, On-Site (Hybrid Flexibility) Reports To: Executive Leadership Team About Aptimized Aptimized is a leading technology consulting firm specializing in innovative solutions that drive business transformation. We deliver high-quality services across ERP, cloud, and...
-
Head of Finance and Legal
4 days ago
Somerset County, NJ, United States Foster McKay Full timeOur client, a leading pharmaceutical company located in Somerset County, NJ is seeking a Finance Manager for a long-term consulting engagement. The highly skilled and motivated Finance Manager will oversee non-study related projects, drive technical solution implementation, and provide essential support to the Leadership team in the US. The role involves...
-
Head of Quality
3 weeks ago
Hoboken, NJ, United States CarePoint Health Full timeA leading health care system in New Jersey is seeking a Director of Quality and Performance Improvement. This role involves leading quality improvement operations, developing evaluation programs for patient care, and requires a Bachelor degree along with prior managerial experience in health care. The company offers competitive pay and comprehensive benefits...
-
Head of Global Regulatory CMC
4 weeks ago
Warren, NJ, United States KayeBassman International Full timeLocation: Warren, NJ Hybrid Position Apply now, read the job details by scrolling down Double check you have the necessary skills before sending an application. My client is a global clinical-stage biopharmaceutical organization focused on developing innovative therapies for immunologic diseases with significant unmet medical needs. They are seeking a Head...
-
Camden, NJ, United States Tandym Health Full timeA health services organization in New Jersey is currently seeking an experienced, licensedGastroenterologist to join their staff as their newPediatric Gastroenterology Division Head. Responsibilities: ThePediatric Gastroenterology Division Head will: Diagnose and treat a wide range of gastrointestinal conditions in children Perform endoscopic procedures and...
-
Quality Investigator
4 weeks ago
Fairfield, United States Partnership HealthPlan of California Full timeOverview To work with a dedicated and committed team, the RN Quality Investigator I is responsible for assessing and improving the quality of care provided by the providers serving our members. Responsibilities Potential Quality Issue Investigation and Resolution Reviews potential quality issues that are referred to the QI department, including a review of...