Top 51 Director of quality Jobs in Rochelle Park Nj

Director, GCP Quality Inspection Management
SK Life Science, Inc. —Paramus, NJ
- $180,000 - $220,000 a year
- Full-time
- Master's degree
- Bachelor's degree
- Training & development
- Health insurance
- Dental insurance
Quality Assurance Director
Safe Flight Instrument —White Plains, NY
- $125,000 - $170,000 a year
- Full-time
- Bachelor's degree
- Product management
- Mentoring
- Tuition reimbursement
- Paid time off
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Director, Quality Systems Global
Balchem Corporation —Montvale, NJ
- $170,000 - $180,000 a year
- Full-time
- Hybrid work
- 7 years
- Analysis skills
- Senior level
Quick Apply
Director of Quality Assurance and Quality Improvement
Coalition for Hispanic Family Services —Brooklyn, NY
- $90,000 - $110,000 a year
- Full-time
- Background check
- Spanish
- 7 years
- Paid holidays
- Disability insurance
Quick Apply
Associate Director-Cell Therapy Lab
New York Blood Center Inc —Rye, NY
- $160,000 - $170,000 a year
- Full-time
- Medicine
- 7 years
- Writing skills
Associate Director of Quality Assurance
NYC Health + Hospitals —New York, NY
- $125,000 - $150,000 a year
- Online Application
- Surgery
- 5 years
- Writing skills
- Commuter assistance
- Paid holidays
Director of Quality Management
NYC Health + Hospitals —New York, NY
- $140,000 - $154,875 a year
- Online Application
- Hospital
- Master's degree
- Administrative experience
- Commuter assistance
- Paid holidays
Director of Quality Management - Inpatient Rehab
Kessler Institute for Rehabilitation - Kessler North (Saddlebrook) —Saddle Brook, NJ
- $105,000 - $140,000 a year
- Full-time
- Nursing
- RN License
- Hospital
- Health insurance
- Dental insurance
Quick Apply
Associate Director, Quality Assurance (Clinical Research Preferred)
IQVIA —Wayne, NJ
- $88,600 - $246,600 a year
- Full-time
- Remote
- Nursing
- Bachelor's degree
- Mentoring
- Work from home
DIRECTOR CLINICAL RISK MANAGEMENT - QUALITY & PATIENT SAFETY - FULL-TIME DAY SHIFT (25480)
Care Plus Bergen, Inc. —Paramus, NJ
- $145,000 - $195,000 a year
- Full-time
- Nursing
- Hospital
- Bachelor of Science
- Paid holidays
- Health insurance
Quick Apply
Director of Quality and Patient Safety
St. Joseph's Health —Paterson, NJ
- $70.94 - $106.42 an hour
- Full-time
- Nursing
- RN License
- 3 years
- 403(b) matching
- Paid holidays
Director, Quality Systems (SM)
BD —Franklin Lakes, NJ
- $211,900 - $339,000 a year
- Bachelor of Science
- Office
- Bachelor's degree
9d
Associate Director, Disclosure Quality & Operations, Hybrid
Merck —Rahway, NJ
- $142,400 - $224,100 a year
- Full-time
- Microsoft Excel
- 5 years
- English
- Paid holidays
- Health insurance
3d
Director of Quality Assurance Operations
Agency DEPT OF CITYWIDE ADMIN SVCS —New York, NY
- $112,993 - $132,934 a year
- Full-time
- 18 years or older
- Management
- Laboratory experience
- Loan forgiveness
DX Head of Regions Quality Management and Regulatory Affairs
Siemens Healthineers —Tarrytown, NY
- $240,000 - $330,000 a year
- Full-time
- Remote
- 11+ years
- English
- Analysis skills
- Disability insurance
- Health insurance
Associate Director of Ingredient Quality & Continuous Improvement
HelloFresh —Newark, NJ
- $140,000 - $170,000 a year
- Call employer
- Travel
- Mentoring
- Recruiting
- Health insurance
- Paid time off
Quick Apply
Director of Compliance and Quality Assurance
Children's Aid —New York, NY
- $90,000 - $100,000 a year
- Hybrid work
- School experience
- Nursing
- 7 years
- Health insurance
Quick Apply
Senior Director of Construction - Quality Branded
Quality Branded —New York, NY
- $175,000 - $200,000 a year
- Weekends as needed
- OSHA
- Construction site
- Computer literacy
Quick Apply
8d
Director of Quality And Reg Affairs
Montefiore New Rochelle —New Rochelle, NY
- $134,000 - $167,500 a year
- Full-time
- Nursing
- Microsoft Excel
- Microsoft Outlook
- Health insurance
- Dental insurance
Quick Apply
Associate Executive Director Of Strategy and Quality & Safety
NYC Health + Hospitals —New York, NY
- $144,550 - $200,000 a year
- Online Application
- Nursing
- RN License
- 5 years
- Commuter assistance
- Paid holidays

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Director, GCP Quality Inspection Management

SK Life Science, Inc.
Paramus, NJ

Apply Now

Job Details

Full-time
$180,000 - $220,000 a year

Benefits

Health insurance
Dental insurance
Vision insurance
401(k) matching

Qualifications

Data integrity assurance
Regulatory inspections
Risk management compliance audits
Program management
Clinical research audit management
Drug regulation
Metrics Reporting
Patient safety
Clinical audit and monitoring
Bachelor's degree
Audit risk assessments
Cross-functional collaboration
Standard operating procedures (SOPs)
Cross-functional communication

Full Job Description

Overview:

The Director of Inspection Management/Quality Compliance will report to the VP and Head of Global Quality. The Director, GCP/GVP QA, leads the end-to-end GCP/GVP QA strategy, compliance, and inspection readiness program across the organization. The role oversees a GCP QA team, drives risk-based audits and quality-by-design integration, and manages quality risk processes, metrics, and compliance oversight for GCP and GVP activities. Key compliance responsibilities include monitoring adherence to GCP/GVP regulations, company SOPs, and ICH guidelines; assessing and reporting compliance status across functions; and ensuring timely remediation of findings from audits and inspections. The Director also maintains regulatory intelligence to anticipate changes in global requirements and translates them into actionable QA and compliance standards. Additional responsibilities include leading inspection readiness internally and at clinical sites with CROs, conducting mock inspections and audits with Compliance QA, and acting as the primary moderator for regulatory sponsor inspections. The Director partners with Clinical Development, Operations, Regulatory Affairs, Patient Safety, Data Management, Biostatistics, and external partners to resolve issues and drive continuous improvement. This role aligns QA and compliance strategy with business and regulatory goals, serves as the primary QA point of contact for stakeholders, and ensures clear communication, transparency, and a unified “One Voice for Quality” across the organization.

Responsibilities:

Establishes and maintains the GCP/GVP Inspection Readiness program and supports the development and revision of functional and cross-functional policies and procedures; supports auditing and compliance monitoring of non-clinical and clinical trials in accordance with applicable health authority regulations and guidelines.
Responsible for the overall health of the GCP/GVP Inspection Readiness program, risks anding with cross-functional stakeholders to identify GCP/GVP issues and risks, and creating a risk log and an overall scorecard that can be applied to manage and mitigate risks.
Develops QA GCP/GVP strategy for a team within QA with clear goals and objectives that align with business needs; manages complex issues leveraging benchmarking data and experience, escalates rapidly when needed, and drives resolution.
Partners with Compliance Clinical Operations for Clinical Site Audits; uses the outcomes to inform risk-based decisions and development or refinement of metrics designed to identify potential noncompliance at SK-sponsored clinical trial sites.
Assesses new regulations and guidance to determine if any changes need to be made to internal GCP and GVP processes and/or if any training needs to be developed and delivered.
Oversees and coaches GCP/GVP QA team members through regular individual touchpoints and team meetings.
Develops a GCP/GVP QA playbook that incorporates past experiences and challenges to train team members to identify common clinical trial issues, such as protocol deviations or potential serious breaches, that could impact patient safety and/or data reliability.
Serves as a GCP/GVP change management agent, establishing and maintaining a culture of quality and compliance.
Reviews and approves, as applicable, non-clinical and clinical trial documents, including clinical study protocols and amendments, risk management plans, etc., and regulatory agency submissions, as applicable.
Partners with key stakeholders, including Clinical Operations, Data Management, Safety, other cross functional teams, and QA oversight of the CROs and other critical vendors.
In partnership with functional stakeholders, identifies and manages issues and risks, making sure to document such issues and risks in a risk log so that risk assessment activities are captured, and awareness of key risks is properly disclosed to the relevant parties.
Interprets and applies ICH E6 (R3), Good Clinical Practice (GCP) ICH regulatory guidelines and directives for clinical trials involving human subjects, in line with the goals and principles of ethics in clinical trials, compliance with the study protocol, informed consent, and protection of confidentiality of the test subject, and quality assurance in clinical trial management.
Provides leadership, compliance, and technical expertise.
Demonstrates cross-functional leadership, establishes strong relationships, and leverages influencing skills and expertise to drive change and foster a culture of quality.
Provides guidance, coaching, and development to the QA team.

Qualifications:

Bachelor’s degree in healthcare or a related field (Master’s degree preferred).
Minimum 15 to 20 Years of solid current pharmaceutical compliance and Inspection Management experience required
Lead end-to-end GCP/GVP inspection readiness programs, including mock inspections, internal audits, and clinical site audits in partnership with Compliance QA and CROs
Serves as primary moderator for regulatory health authority sponsor inspections, triaging first-level questions, managing complex requests, and defending company processes and positions to achieve successful outcomes
Develops and maintains a risk-based QA strategy and quality-by-design framework across GCP and GVP functions, systems, and activities
Monitors compliance with GCP, GVP, guidelines, and internal SOPs; tracks key metrics to inform risk-based decisions and drive timely remediation of audit findings
Collaborates with Clinical Development, Clinical Operations, Regulatory Affairs, Patient Safety, Data Management, and Biostatistics to identify, assess, and mitigate patient safety and data integrity risks
Builds and maintains relationships with functional leaders as the primary QA point of contact, ensuring “One Voice for Quality” in strategic and decision forums
Delivers training and coaching to cross-functional SMEs on inspection preparation and effective response to regulatory questions
Manages complex compliance issues with limited data, applying sound judgment to balance business needs, supply, and quality requirements
Implements process improvements based on peer company best practices and evolving global regulatory expectations to strengthen inspection readiness
Drives measurable outcomes by aligning QA and compliance initiatives with business goals and regulatory commitments

Compensation & Benefits

The anticipated salary range for this position is $180,000 to $220,000. Actual compensation may vary based on factors including experience, qualifications, skills, and business needs.

In addition to base salary, SK Life Science offers a competitive benefits package, including a 401(k) plan with company match and medical, dental, and vision coverage. Benefits are subject to eligibility requirements and may be modified at the Company's discretion.

Apply Now

Refine Your Search

director of quality jobs in rochelle park nj

Director, GCP Quality Inspection Management

Quality Assurance Director

Director, Quality Systems Global

Director of Quality Assurance and Quality Improvement

Associate Director-Cell Therapy Lab

Associate Director of Quality Assurance

Director of Quality Management

Director of Quality Management - Inpatient Rehab

Associate Director, Quality Assurance (Clinical Research Preferred)

DIRECTOR CLINICAL RISK MANAGEMENT - QUALITY & PATIENT SAFETY - FULL-TIME DAY SHIFT (25480)

Director of Quality and Patient Safety

Director, Quality Systems (SM)

Associate Director, Disclosure Quality & Operations, Hybrid

Director of Quality Assurance Operations

DX Head of Regions Quality Management and Regulatory Affairs

Associate Director of Ingredient Quality & Continuous Improvement

Director of Compliance and Quality Assurance

Senior Director of Construction - Quality Branded

Director of Quality And Reg Affairs

Associate Executive Director Of Strategy and Quality & Safety

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