Top 17 Director of quality Jobs in Mount Arlington Nj

Sr. Director of Quality Operations
Harrow, Inc. —Ledgewood, NJ
- $220,000 a year
- Call employer
- Microsoft Excel
- Engineering
- Master's degree
Quick Apply
Director Commercial Quality US
Teva —Parsippany-Troy Hills, NJ
- $173,000 - $216,000 a year
- Email
- Master's degree
- Mentoring
- Senior level
- Paid parental leave
- Health savings account
Director, Data Management Process, Quality & Inspection Readiness
Regeneron —Warren, NJ
- $183,100 - $305,200 a year
- Office
- Bachelor's degree
- Travel
- Health insurance
- Dental insurance
Quality Director
Schindler —Morristown, NJ
- $164,200 - $202,300 a year
- Engineering
- Mentoring
- Organizational skills
- Health insurance
- Dental insurance
2d
Director, Quality Control
Ferring Pharmaceuticals, Inc. —Parsippany-Troy Hills, NJ
- $158,136 - $194,472 a year
- Full-time
- Oracle
- 11+ years
- Microsoft Office
- Paid parental leave
- Paid holidays
Director, Quality Compliance
Cellares —Bridgewater, NJ
- $90,000 - $250,000 a year
- Full-time
- 5 years
- Mentoring
- Senior level
- Health insurance
- Dental insurance
Senior Director, Experience Assurance: UAT & Quality Innovation
Information Technology Senior Management Forum —Basking Ridge, NJ
- $176,500 - $339,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Office
- Paid parental leave
- AD&D insurance
11d
Senior Director, Experience Assurance: UAT & Quality Innovation
Verizon —Basking Ridge, NJ
- $176,500 - $339,000 a year
- Full-time
- Hybrid work
- Computer science
- Computer Science
- Office
- Paid parental leave
- AD&D insurance
11d
Director, Quality and Regulatory
CELULARITY LLC —Florham Park, NJ
- $190,000 - $230,000 a year
- Full-time
- Senior level
- Leadership
- Communication skills
Quick Apply
Associate Director - Digital Solutions Quality Lead
BD —Franklin Lakes, NJ
- $157,700 - $260,400 a year
- Office
- 8 years
- Bachelor's degree
- Wellness program
- Commuter assistance
Head of Quality Assurance, Drug Product, GMP QA
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $226,275 - $377,125 a year
- English
- Bachelor's degree
- Travel
Quality Assurance Director - GMP ESO Biotechnologies
Recordati —Bridgewater, NJ
- $149,160 - $223,740 a year
- Weekends as needed
- Hybrid work
- 11+ years
- English
- Office
- AD&D insurance
- Paid holidays
Associate Director - Digital Solutions Quality Lead
Information Technology Senior Management Forum —Franklin Lakes, NJ
- $157,700 - $260,400 a year
- Full-time
- Office
- 8 years
- Bachelor's degree
- Wellness program
- Commuter assistance
Associate Director, Site Quality Compliance Lead
Legend Biotech US —Raritan, NJ
- $168,372 - $220,988 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quick Apply
Director, Software Quality Engineering
Everest Group, Ltd. —Warren, NJ
- $134,000 - $155,000 a year
- Full-time
- Hybrid work
- Computer Science
- Bachelor's degree
- Mentoring
- Wellness program
- Paid holidays
Director, PV QA DSI
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $184,240 - $276,360 a year
- Master's degree
- Bachelor's degree
- Mentoring
Associate Director, External Supplier QA GMP
Daiichi Sankyo, Inc. —Basking Ridge, NJ
- $153,600 - $230,400 a year
- Master's degree
- Bachelor's degree
- Product management

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Sanofi EU —Morristown, NJ
Bachelor's degree in Supply Chain Management, Logistics, Operations Management, Business, Engineering, or related field. BS / BA, or other advanced degree.
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Associate Director, Strategic Products and Portfolio Planning
Sanofi EU —Morristown, NJ
Exceptional project management capabilities with experience driving strategic initiatives. The ideal candidate thrives in fast-paced environments, seamlessly…
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Knowledge and skills at a level normally acquired through the completion of Bachelor’s degree in human services or behavioral healthcare field.
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Sr. Director of Quality Operations

Harrow, Inc.
Ledgewood, NJ

Quick Apply

Job Details

$220,000 a year

Qualifications

Regulatory inspections
Microsoft Excel
Team leadership
Professional ethics
Employee relationship building
Manufacturing facility experience
Team development
Supervising experience
Pharmaceutical company experience
Productivity software
Pharmaceutical manufacturing facility experience
Team building
Database software proficiency

Full Job Description

Before reading the job post, we encourage you to watch this video about our company. It gives you an inside look at how we started, the team and culture that made us successful, and where we're going. It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in. If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.

Who is Harrow?

Harrow (Nasdaq: HROW) is a leading provider of ophthalmic disease management solutions in North America. Harrow is an incredible entrepreneurial company – where we celebrate the ability of every member of the Harrow Family to be the CEO of their job. Harrow's values have driven interest over the past decade in attracting high-performing professionals in a variety of disciplines. Members of our Harrow Family often express their pride in being a part of our commitment to (1) innovation, (2) patient access to affordable medicines, and (3) our track record of having never turned down an ophthalmologist doing mission work around the world – providing free medicines in support of mission work aimed at giving or maintaining the gift of sight to those most in need. We encourage you to learn more about Harrow and its unique culture to see if you're the right person to help contribute as we build a truly exceptional company, one we are all so proud of!

Harrow's ophthalmic pharmaceutical portfolio is one of the most comprehensive in the industry, including:

An expanding Retina Portfolio including IHEEZO®, TRIESENCE®, BYOOVIZTM, and OPUVIZTM
A broad Dry Eye Disease product line, led by VEVYE® and bolstered by well-known adjacent ocular surface disease products such as FLAREX® and FRESHKOTE®
A peri-operative Surgical product line, led by TRIESENCE®, and BYQLOVITM
A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO®, NATACYN®, and VERKAZIA®
A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01

Job Summary

Under the leadership of the Head of Quality, the Sr. Director of Quality Operations will oversee and lead the day-to-day operations of the Quality Assurance and Quality Control teams. They will oversee the quality of the company's 503B outsourcing facility in Ledgewood, NJ, to deliver business results focused on ensuring quality and compliance. Key aspects of the job include managing the Quality Unit to ensure consistent GMP compliance, product quality, and inspection readiness across the site or organization. The successful candidate must demonstrate the ability to build and maintain teams, relationships, trust, and respect with employees, peers, and regulators. The successful candidate is a proactive leader passionate about resolving issues and improving processes to facilitate growth.

The incumbent will lead and meet the company's goals in product quality, staff development, and leadership. Will interact with all State and Federal governmental agencies (FDA, DEA, State boards of pharmacy, etc.). This position will ensure the established quality procedures are followed for the compounding of sterile and non-sterile drugs under section 503B of the US Food, Drug & Cosmetic Act. It is critical to ensure a continuous and sustainable state of cGMP compliance.

Responsibilities will include leadership over adherence to the site's quality systems. This includes standard operating procedures, documentation control, change control, deviation & complaint handling, CAPA, quality control processes (analytical chemistry and microbiological testing, stability, and retention program), and material controls (including raw material, component and finished good batch release process).

Core Responsibilities

Manage direct reports in Quality Assurance and Quality Control departments at Harrow's Imprimis NJOF site in Ledgewood, NJ.
Lead and direct the activities involved in day-to-day quality operations to ensure compounding quality controls and procedures are following Standard Operating Procedures (SOPs), US current Good Manufacturing Practices (cGMPs), US Food and Drug Administration (FDA) standards, and specifications, including USP/NF monographs, Boards of Pharmacy for each State.
Establish quality strategy, priorities, and resource allocation to support manufacturing, testing, and supply objectives
Provide quality oversight of manufacturing, packaging, labeling, validation, and technology transfer activities
Partner with Manufacturing, MS&T, Supply Chain, and Compliance on quality-related decisions
Sustain a level of perpetual inspection readiness by maintaining and improving appropriate systems, processes, and procedures to meet regulatory requirements, guidelines, and industry standards
Oversee the managers responsible for the activities of internal QC laboratories and external contract testing laboratories
Lead both state and federal health/drug authority inspections
Collaborate with Pharmacist-in-Charge to respond to state and federal health/drug authorities about inquiries or deficiencies identified during inspections
Track the status of agency commitments and ensure such obligations are met
Oversee the batch review and release process, ensuring thorough review and timely disposition of raw materials, components, and finished drug products
Track and manage the quality release status of all in-process lots, ensuring compliance, optimal timing, and alignment with evolving release plan priorities
Provide leadership over investigations into out-of-specification analytical results and deviations during compounding activities to determine root cause and identify CAPAs to prevent recurrences
Ensure data integrity of all documentation and data supporting compounded drug products that are commercially distributed
Engage in activities to continuously assess and improve the site's quality systems by identifying and proactively resolving quality issues as needed
Establish and monitor metrics for the measurement of Quality's Key Performance Indicators to ensure the site's quality systems and distributed products consistently and efficiently meet the highest quality standards for patients
Lead quarterly Management Reviews with the Leadership Team
Participate in Quality Governance Council meetings
Planning, budgeting, and administration of expenditures required for the execution of departmental activities
Develop weekly/monthly/quarterly/annual goals and schedules to manage activities and the team
Must be able to manage a heavy workload and aggressive timelines promptly, prioritize, and work under pressure
Serve as a coach and mentor to the quality unit staff, providing development and training opportunities.
Perform duties following established company procedures and policies; perform other duties as assigned.

Qualifications & Requirements

Bachelor's degree in Science or Engineering or related field or equivalent work experience required; Master's degree preferred
10+ years of progressive experience in a leadership role within a cGMP facility
People management experience, including experience managing or supervising large groups (20+ employees)
Strong technical understanding of manufacturing, laboratory, and quality systems
Proven leadership in regulatory inspections and complex quality decision-making
Ability to balance compliance, operational efficiency, and business priorities
Experience with aseptic drug product bulk manufacturing process, preferred
Ability to complete tasks autonomously with little direction or need for supervisory follow-up
Strong written, verbal, and presentation communication skills
Strong computer skills in Microsoft Office Suite, database management, and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software and programs, as required)
Ability to think creatively in confronting new issues and pursuing novel approaches to old problems
Ability to work under pressure, meet deadlines, and exercise sound business judgment with critical thinking skills and high ethical standards
Ability to influence without direct authority

Position Type

On-Site

Travel

Ability to travel up to 10% of the time. Must be able to travel independently as a Harrow representative.

Comp: 220k +

Quick Apply

Refine Your Search

director of quality jobs in mount arlington nj

Sr. Director of Quality Operations

Director Commercial Quality US

Director, Data Management Process, Quality & Inspection Readiness

Quality Director

Director, Quality Control

Director, Quality Compliance

Senior Director, Experience Assurance: UAT & Quality Innovation

Senior Director, Experience Assurance: UAT & Quality Innovation

Director, Quality and Regulatory

Associate Director - Digital Solutions Quality Lead

Head of Quality Assurance, Drug Product, GMP QA

Quality Assurance Director - GMP ESO Biotechnologies

Associate Director - Digital Solutions Quality Lead

Associate Director, Site Quality Compliance Lead

Director, Software Quality Engineering

Director, PV QA DSI

Associate Director, External Supplier QA GMP

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