20 Best director of quality jobs in Raritan, NJ (Hiring Now!)

Director, Quality Assurance Operations
Johnson & Johnson —Raritan, NJ
Manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and developing capabilities.
$142,000 - $284,000 a year
4d
Senior Director, Head of PV Quality (US/Europe)
Daiichi Sankyo, Inc. —Basking Ridge, NJ
The incumbent must aim to instill a consistent quality mindset and culture through partnering with stakeholders to streamline the product lifecycle process and…
Estimated: $205K - $260K a year
1d
Associate Director, Operations Compliance and Investigations Management
Legend Biotech US —Raritan, NJ
The incumbent will be responsible for providing oversight and co-leadership of the investigation management system, including technical and performance…
Estimated: $98.9K - $125K a year
Quick Apply
Sr Director Quality Assurance Operations
Insmed Incorporated —Bridgewater, NJ
Ability to drive functional, technical, and operational excellence. Ability to motivate a team, recognize and develop good talent and bring out the best out of…
$200,000 - $280,000 a year
Associate Director, Tech Ops (Process Chemistry)
Insmed Incorporated —Bridgewater, NJ
Responsible for the management of API/Intermediate/RSM manufacturing operations at Insmed’s CMOs including oversight of tech transfer, scale-up, process…
$135,000 - $188,333 a year
13d
Associate Director Compliance - Head of Compliance
Avet Pharmaceutical —East Brunswick, NJ
Ensures that all Avet Laboratories, Avet Pharmaceuticals, Inc., and Avet Life Sciences sites are continually in a state of cGMP inspection readiness by driving…
Estimated: $76.6K - $97K a year
Quick Apply
3d
Director, GxP Audits and Inspections
Amicus Therapeutics —Princeton, NJ
This position will develop and support strategic audit plans, executing GXP and PV audits, support vendor onboarding/qualification, and supplier quality…
$200,000 - $210,000 a year
Quick Apply
VP, Head of Operations Training, QA and Feedback Management
Combined Insurance —Whitehouse Station, NJ
Collaborate with Operations leads to develop action plans, set quality goals, and track progress driving continuous improvement initiatives.
Estimated: $118K - $149K a year
Sr Director Quality Assurance - Pharmacovigilance
Insmed Incorporated —Bridgewater, NJ
Supports strategic direction with cross functional working groups to identify and mitigate GVP quality and compliance issues/risks. Paid time off to volunteer.
$200,000 - $280,000 a year
Sr Director, Quality Systems & Compliance
Bristol-Myers Squibb —Summit, NJ
This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. For field-based and remote-by-design roles the ability to…
Estimated: $132K - $168K a year
VP, Head of Operations Training, QA and Feedback Management
Chubb —Whitehouse Station, NJ
Collaborate with Operations leads to develop action plans, set quality goals, and track progress driving continuous improvement initiatives.
Estimated: $158K - $200K a year
Associate Director, External Quality Lead (Small Molecule)
Amicus Therapeutics —Princeton, NJ
Identify problems through trend and investigational data and conduct independent or team driven problem-solving using root cause analysis.
Estimated: $93.1K - $118K a year
Associate Director, Clinical Quality Operations, (Remote)
Merck Sharp & Dohme —Rahway, NJ
Overseeing the strategic implementation of `quality by design` principles in assigned clinical trials. The incumbent will be tasked with the development of…
$135,500 - $213,400 a year
Director, Team Leader, External Data Quality Management, Clinical Data Management
Genmab —Princeton, NJ
In collaboration with the Senior Director, Team Lead, External Data Management, contributes to and supports the strategic direction of External Data Management…
Estimated: $217K - $274K a year
Associate Director, GMP QA
Genmab —Princeton, NJ
Providing QA oversight of contractors/vendors in relation to outsourced GMP/GDP activities including Audits, Vendor Risk Evaluations, and review of Quality…
Estimated: $170K - $215K a year
11d
Director, Quality Ethics
Hackensack Meridian Health —Edison, NJ
Terminal degree in a relevant field (MD/DO, JD, PhD). Minimum of 5 years experience in the field. This role collaborates closely with stakeholders responsible…
Estimated: $153K - $193K a year
Associate Director, Global Strategy and Operations (Global R&D PV QA)
Daiichi Sankyo, Inc. —Basking Ridge, NJ
Support Head, Global strategy and operations to develop and plan the Global QA governance, communication strategies and manage the communication activities;
Estimated: $156K - $198K a year
Associate Director IT QA, Emerging Technologies
Genmab —Princeton, NJ
Education: Minimum Bachelor's Degree, MS in Natural Science, IT, or a related field preferred. Process Optimization: Continuously seek and implement…
Estimated: $114K - $144K a year
Associate Director, Principal Product Quality Lead, Cell Therapy
Bristol-Myers Squibb —Summit, NJ
The Principal PQL assists the Global PQL to develop and implement global product quality strategies relating to manufacturing, development, control strategies,…
Estimated: $105K - $133K a year
4d
Director-Clinical Quality & Risk Management
ADC Therapeutics America Inc —New Providence, NJ
The position supports design and implementation of efficient clinical trial protocols including tools and procedures for trial conduct (including data…
Estimated: $151K - $191K a year

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Director, Quality Assurance Operations

Johnson & Johnson - Raritan, NJ

Apply Now

Job Details

Full-time $142,000 - $284,000 a year 4 days ago

Benefits

Disability insurance
Health insurance
Dental insurance
Vision insurance
Life insurance

Qualifications

CGMP
Quality assurance
Bachelor's degree
Team management
Leadership
FDA regulations
10 years

Full Job Description

Janssen Pharmaceutical, a member of Johnson & Johnson's Family of Companies, is recruiting for a Director, Quality Assurance Operations– CAR-T Manufacturing ! This position will be located in Raritan, NJ.

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. As the world’s largest and most broadly-based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Position Summary:

The Director, Quality Operations Head, Raritan Cell Therapy Manufacturing Operations leads and handles all aspects of Quality Operations in support of the Raritan CAR T manufacturing site, in full compliance with established cGMP, J&J and JSC requirements. Functions and activities include Quality oversight of QA Incoming, QA Shop Floor, Batch Record Review and Release, Cryopreservation, Lenti, and QCBB production facilities. Manages a team of people leaders and technical professionals within the QA based on assigned work, direction, mentoring and developing capabilities. Develops and implements long-term strategies, and execution of Quality programs.

Key Responsibilities:

Drives the strategy and adherence to cGMP compliance for the site.
Proactively identifies recurring trends, and implements a Right First Time program in collaboration with manufacturing and QC operations to reduce deviations and improve efficiency.
Provides leadership and direction to the Quality and Site Management Teams to ensure business, quality and compliance goals are met following the J&J Standard of Leadership behavior model.
Develops and champions an interpersonal culture that promotes behaviors that lead to outstanding business performance and organizational excellence.
Responsible for appropriately staffing and developing the Quality Operations organization to meet budget and succession plans.
Leads launches of new products and technologies. Participates in product stage gate reviews representing Site Quality Assurance.
Partners with the Compliance Team to prepare for and support Health Authority inspections at Raritan. Leads and hosts compliance audits. Serves as SME for QA operations to support all regulatory inspections.
Ensures that all external customer complaints and internal complaints from affiliates are handled, evaluated and investigated in timely and effective manner, in conformance with cGMP’s, Janssen Supply Chain Policies and Procedures.

Qualifications

Education:

A minimum of a bachelor’s degree in Science is required, preferably in Biology, Microbiology, Chemistry, Pharmacy, Biochemistry, Chemical Engineering or related Science or Engineering.

Required:

Demonstrated experience building and leading exceptional Quality Assurance teams.
A minimum of 10 years relevant work experience, with 5 of those years managing a team of senior leaders and professionals within Quality Assurance.
Experience with implementing and coordinating GMP operations in a commercial manufacturing facility.
Knowledgeable of Quality Risk Management concepts.
Experience in regulated environment (FDA, EMA) and other worldwide regulatory agencies and regulatory inspections.
Comfortable speaking and interacting with inspectors.
Excellent communication, interpersonal relation, collaboration, and influencing skills.

Preferred:

Significant experience with Advanced Therapies is preferred.

Other:

This position may require up to 10% domestic travel.
This position has an estimated annual salary of 142,000- 284,000USD$
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company’s long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation – up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington – up to 56 hours per calendar year
- Holiday pay, including Floating Holidays – up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Apply Now

director of quality jobs in Raritan, NJ

Director, Quality Assurance Operations

Senior Director, Head of PV Quality (US/Europe)

Associate Director, Operations Compliance and Investigations Management

Sr Director Quality Assurance Operations

Associate Director, Tech Ops (Process Chemistry)

Associate Director Compliance - Head of Compliance

Director, GxP Audits and Inspections

VP, Head of Operations Training, QA and Feedback Management

Sr Director Quality Assurance - Pharmacovigilance

Sr Director, Quality Systems & Compliance

VP, Head of Operations Training, QA and Feedback Management

Associate Director, External Quality Lead (Small Molecule)

Associate Director, Clinical Quality Operations, (Remote)

Director, Team Leader, External Data Quality Management, Clinical Data Management

Associate Director, GMP QA

Director, Quality Ethics

Associate Director, Global Strategy and Operations (Global R&D PV QA)

Associate Director IT QA, Emerging Technologies

Associate Director, Principal Product Quality Lead, Cell Therapy

Director-Clinical Quality & Risk Management

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