Director, External Manufacturing Regulatory Compliance Oversight

$150k - $258.75k

Johnson & Johnson

Johnson & Johnson seeks a Director to provide independent regulatory compliance oversight across external manufacturing partners. The role monitors compliance risks, supports inspection readiness, and drives organizational learning to strengthen performance across the contract manufacturing network.

Responsibilities

Monitor and assess significant compliance risks across assigned external manufacturing partners
Conduct independent risk assessments and provide objective compliance challenge to operations teams
Provide oversight of inspection readiness activities, mock inspections, and regulatory responses
Evaluate corrective and preventive actions for effectiveness and sustainability of remediation
Facilitate deployment of inspection learnings and best practices across the external manufacturing network

Requirements

Extensive regulatory compliance experience in pharmaceutical manufacturing or external manufacturing oversight
Demonstrated expertise in health authority inspections and compliance assessment methodologies
Strong knowledge of FDA regulations, GMP requirements, and pharmaceutical quality standards
Leadership experience managing compliance programs and cross-functional stakeholder engagement
Proven ability to conduct independent risk assessments and provide objective compliance recommendations
Experience with CAPA processes, root cause analysis, and remediation effectiveness evaluation

Apply

Vacancy posted 27 days ago

Similar jobs that could be interesting for youBased on the Director, External Manufacturing Regulatory Compliance Oversight in Raritan, NJ vacancy

Senior Director, External Manufacturing Regulatory Compliance
$178k - $307.05k
...recognize their merit. Job Function: Legal & Compliance Job Sub Function: Enterprise Compliance... ...of America Job Description: The Senior Director External Manufacturing Regulatory Compliance Oversight provides enterprise-level regulatory compliance...
Suggested
Full time
Contract work
Local area
Immediate start
Johnson & Johnson
New Brunswick, NJ
1 day ago
Director of Field Operations
$150k - $175k
...sustainable future. SUMMARY: The Director of Field Operations provides strategic... ..., training, maintenance coordination, regulatory compliance, and process improvement initiatives while... ...: Provides leadership and oversight to regional operations personnel and frontline...
Suggested
Temporary work
For contractors
Work at office
Local area
Monday to Friday
Applied Water Managemen
Hillsborough, NJ
2 days ago
Head of Operations & Business Management
$30 - $35 per hour
...operational response. Provide disciplined oversight of financial management, cost control, regulatory and code compliance, personnel management, staff development, health... ...corrective actions. Oversee internal and external technical, statutory, and regulatory...
Suggested
Temporary work
Zealogics.com
Somerset, NJ
18 days ago
Sr. Manager, Cryopreservation Operations
...Job Function: Supply Chain Manufacturing Job Sub Function: Plant Management... ...leading and driving long-term strategy and regulatory compliance while striving for world-class... ...would like to request an accommodation external applicants please contact us via internal...
Suggested
Full time
Work experience placement
Local area
Immediate start
Johnson & Johnson
Raritan, NJ
1 day ago
Senior Regulatory Operations Specialist (Remote)
$86.58k - $123.3k
...POSITION OVERVIEW: The Senior Regulatory Operations Specialist is an... ..., technology teams, and external providers to deliver... ...issues that may affect quality, compliance, cost, or timing. Represent... ..., access, changes, vendor oversight, performance checks, and recordkeeping...
Suggested
Remote work
Nestlé
Bridgewater, NJ
a month ago
Director of Operations
...Position: Director of Operations Location: Branchburg, NJ (Fully on site)... ...serve as the key point of contact to external contractors. Review and approve all... ..., equipped, and operating safely in compliance with all regulatory and company standards. Coordinate...
For contractors
For subcontractor
Addition Management
Somerville, NJ
3 days ago
Sr. Manager, Cryopreservation Operations
...Operations Manager overseeing Cryopreservation, MOI, and QCCB manufacturing for Johnson & Johnson's cell therapy facility in Raritan, NJ. Objectives include scaling-up operations, ensuring regulatory compliance, driving continuous improvement, and building high-...
Johnson & Johnson Innovative Medicine
Raritan, NJ
3 days ago
Sr. Manager, Cryopreservation Operations
...Manager position leading cryopreservation and cell therapy manufacturing operations at a Raritan, New Jersey facility. The role involves developing long-term operational strategy, ensuring regulatory compliance, building high-performing teams, and driving continuous improvement...
Johnson & Johnson
Raritan, NJ
8 days ago
Operations Supervisor
...operations (i.e. component preparation manufacturing, MFG support operations, Mock cell, and... ...production task to execute and ensure compliance and successful completion of work-related... ...and effectively integrate with external collaborators to drive projects/programs...
Work at office
Worldwide
Shift work
Day shift
Afternoon shift
Legend Biotech
Raritan, NJ
11 hours ago
Head of Operations **URGENT**
$85k - $100k
...privately owned and have been servicing manufacturing & retail companies of all sizes for almost... ...federal DOT/OSHA standards. · Ensure company operational model compliance. · Support a culture of excellence in quality of product to internal and external customers...
Full time
Immediate start
Monday to Friday
Flexible hours
Shift work
Night shift
Central Transport
New Brunswick, NJ
1 day ago
Operations Manager
$300 per month
...on grievances, direct the job-site safety program, and sit on the joint safety and policy committees with DC21 Union and Labor Compliance Serve as the company's contact with DC21 and other IUPAT district councils, and keep NWF in good standing with DC21 and its funds...
Daily paid
Full time
Contract work
For contractors
Local area
Trial period
Shift work
American Window Film
Bound Brook, NJ
1 day ago
Manager, Strategy and Operations
$102k - $177.1k
...recognize their merit. Job Function: Regulatory Affairs Group Job Sub Function:... ...Operations (SPO) organization. Reporting to the Director, Global Regulatory Affairs Strategy,... ...would like to request an accommodation, external applicants please contact us via , internal...
Full time
Local area
Immediate start
Flexible hours
Johnson & Johnson Innovative Medicine
Raritan, NJ
1 day ago
Plant Operations Manager - Recycling
$104.4k - $143.55k
...programs and leads all operations to ensure compliance with standards. The position is also... ...Facility by providing management oversight to all operations staff. Manage staff... ...standards including environmental, operating, regulatory, safety, accounting and ethics....
Minimum wage
Contract work
Temporary work
Traineeship
Seasonal work
Local area
Republic Services
New Brunswick, NJ
2 days ago
Clinical Operations Director LCSW
...and Warren Counties is seeking a dynamic and detail oriented Director of Clinical Operations to lead and elevate their clinical... ...operations across all service lines, ensuring quality care and regulatory compliance Provide clinical supervision, mentorship, and...
Full time
Jewish Family Service of Somerset
Somerville, NJ
a month ago
Nutraceutical Production Manager
...science-based formulations, rigorous quality standards, and compliance with applicable regulatory requirements. Genova Pharma works closely with... ...NJ. This role is responsible for overseeing day-to-day manufacturing operations for nutraceutical products, including planning...
Full time
Genova Pharma
New Brunswick, NJ
1 day ago
Publication Operations Manager II
$55 - $60 per hour
...direct client, a global pharmaceutical manufacturing client in Basking Ridge, NJ. No Third... ...drive the execution of internal and external scientific communication strategy and related... ...approvals. Ensure documentation of compliance with authorship and publication guidelines...
Hourly pay
Contract work
Temporary work
Work at office
Local area
Remote work
Source One Technical Solutions
Basking Ridge, NJ
1 day ago
Associate Director, Manufacturing Science and Technology - Drug Product
...Therapeutics seeks an Associate Director to provide technical and operational oversight of drug product manufacturing for small molecule programs... ..., process validation, regulatory interactions, and on-site production... ...to ensure GMP and ICH compliance. Responsibilities...
Contract work
PTC Therapeutics
Warren, NJ
8 days ago
Sr. Manager Clinical Supply Operations
$146.41k - $192.16k
...role will report to the Director of Patient Supply... ...sites, depots, CROs, and external vendors. The successful... ...Effective use and oversight of IRT, inventory, vendor... ...CMC, Quality Assurance, Regulatory Affairs, Technical... ...improvements that support compliance, cost, timelines, data...
Permanent employment
Full time
Temporary work
For contractors
Local area
Worldwide
Flexible hours
Legend Biotech USA, Inc.
Somerset, NJ
26 days ago
Procurement Operations Specialist
...to-end lifecycle of R&D and manufacturing suppliers. This role balances... ...) with strict quality compliance. The candidate will act as the... ...Management System (QMS) workflow for external vendors, driving audits,... ...standards and external regulatory requirements. Core Responsibilities...
Contract work
Lupin Pharmaceuticals
Somerset, NJ
3 days ago
Senior Director, Clinical Operations
$240k - $270k
...Translational Medicine, CMC, Quality, Regulatory, Safety, sites, CROs, and vendors; Lead... ...preferred. Clinical Trial Operations Oversight: Manage operational execution of... ...regulatory expectations, and internal SOP compliance. Ability to travel up to 25% as...
Contract work
Interim role
Shift work
Century Therapeutics, Inc
Neshanic Station, NJ
15 hours ago
Operations Manager - BPF Production Catalogue
$103.1k - $160k
...Shift (Days) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Fluctuating Temps hot/cold,... ...end performance. • Maintain applicable quality, safety, regulatory, and operational standards. • Lead problem-solving and...
Full time
Temporary work
Work at office
Day shift
Bridgewater, NJ
a month ago
Business Operations Associate
...asset management, development excellence projects, lab operations, project management, resource management, external engagement, operational excellence and compliance. We are seeking a detail-oriented and highly motivated individual to join our team. This role will be...
Work at office
Omni Inclusive
New Brunswick, NJ
5 days ago
Senior Manager / Associate Director, Market Access Operations + Patient Services
...multiple workstreams, coordinate internal and external partners, resolve issues, and build... ...at Senior Manager or Associate Director will reflect experience and demonstrated... ...improvements with Commercial, Finance, Legal, Compliance, and external partners. Identify recurring...
Full time
Contract work
Alembic Therapeutics LLC
Bedminster, NJ
3 days ago
Production Planner
$75.31k - $100.41k
...applications. Ferrero USA, a leading global confectionery manufacturer with a strong track record of innovations and a great reputation... .... The Production Planner works closely with internal and external stakeholders to understand and evaluate throughput, capacity constraints...
Full time
Temporary work
Work at office
Local area
Overseas
Rotating shift
Afternoon shift
Ferrero
Somerset, NJ
16 days ago
Lab Operations Supervisor: Inventory & Compliance
Avantor’s Advanced Laboratory Services in Raritan, NJ is seeking an experienced operations leader to manage inventory, compliance, and customer-focused service in a regulated life sciences environment. You will guide a team of coordinators and technicians, oversee audits...
Avantor
Raritan, NJ
5 days ago
Operations Associate
$57.45k - $75.4k
.... Role Overview This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP... ...responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable...
Permanent employment
Full time
Temporary work
For contractors
Local area
Worldwide
Flexible hours
Shift work
Afternoon shift
BioSpace
Raritan, NJ
11 hours ago
Industrial Wastewater Assistant Plant Manager
$83k - $97.76k
...groundwater and stormwater treatment systems. Help ensure regulatory compliance with permits, reporting requirements, and environmental... ...Stormwater treatment operations Contractor management Budget oversight Environmental compliance programs Physical & Work...
Full time
For contractors
Work at office
Flexible hours
Woodard & Curran
Bound Brook, NJ
27 days ago
Operations Specialist
$53.04k - $75.89k
...organizations administrative functions ensuring efficient workflow and compliance with organizational policies. Works closely with various... ...records and ensure compliance with hospital policies and regulatory requirements. -Provide administrative support for special projects...
Full time
Work at office
Remote work
Monday to Friday
Flexible hours
Shift work
Mass General Brigham
Somerville, NJ
1 day ago
Executive Operations Sr Manager AI Connect
$108k - $188k
...communications and prepare high-level presentations for both internal and external audiences. Responsibilities will include: Build and... ...by your manager. Employees are responsible for maintaining compliance with hybrid work policies. Scheduled Weekly Hours 40...
Full time
Temporary work
Part time
Work experience placement
Work at office
Work from home
Shift work
3 days per week
Verizon Services BC
Basking Ridge, NJ
1 day ago
Senior Manager, Clinical Operations
...to oversee the planning, execution, and compliance of clinical trials across Phase I-IV... ...cross-functional collaboration, vendor oversight, and may include direct report management... ...trials comply with ICH-GCP guidelines, regulatory requirements, and company SOPs Manage...
Contract work
Work at office
PTC Therapeutics
Warren, NJ
8 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Director, External Manufacturing Regulatory Compliance Oversight. Be the first to apply!