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 19 days ago

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

Senior Director, External Manufacturing Regulatory Compliance
$178k - $307.05k
...Johnson & Johnson seeks a Senior Director to provide enterprise-level regulatory compliance oversight across the Innovative Medicine external manufacturing network. The role leads compliance strategy, risk visibility, and governance while working across a matrixed global...
Suggested
Contract work
Johnson & Johnson
New Brunswick, NJ
19 days ago
Hardware Break/Fix Operations Manager
$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
10 days ago
VP of Operations
$300k - $330k
...Maintain accountability for compliance with applicable environmental, safety, reliability, and regulatory requirements, including EPA,... ...standards. Provide strategic oversight of leadership development,... ...to lead diverse internal and external teams. #ENG1
Suggested
Relocation
Day shift
Primary Recruiting Services
East Brunswick, 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....
Suggested
Minimum wage
Contract work
Temporary work
Traineeship
Seasonal work
Local area
Republic Services
New Brunswick, NJ
4 days ago
Operations Manager (Onsite)
$117k - $184.2k
...Pilot Plant. This organization manufactures sterile drug products... ...professionals and provides daily oversight of sterile manufacturing... ...Safety First, Quality Always, compliance, and reliable delivery.The successful... ..., Supply Chain, and Regulatory partners to ensure compliant...
Suggested
Full time
For contractors
Local area
Flexible hours
Shift work
Day shift
Merck Sharp & Dohme (MSD)
Rahway, NJ
17 hours ago
Water Treatment Process Engineer
$80k - $180k
.... With a focus on integrating technology, sustainability, and compliance, we consider each project a chance to innovate and evolve to protect... ...to professional development, access to internal and external training programs, and support of active participation in professional...
Full time
Remote work
GFT
East Brunswick, NJ
9 hours ago
Regional Airport Operations - Lead / Supervisory Transportation Security Officer
$25 - $50 per hour
...TSP Overtime and premium pay Career growth opportunities Key Responsibilities Supervise screening teams Ensure TSA compliance Train and mentor officers Manage checkpoint operations Disclaimer This is not a direct job offer from TSA. This...
Shift work
Night shift
Weekend work
Airport Security Careers
North Brunswick, NJ
2 hours 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
18 days ago
Assistant Manager - Operations
...environmentally conscious operations that are in compliance with Company mission, policy, and... ...in compliance with company and regulatory requirements and ensuring representation... ...professionalism when dealing with internal and external customers, and when handling sensitive...
Full time
Work at office
Local area
Buckeye Partners
Port Reading, NJ
4 days ago
Microbiology Operations Manager
$95k - $105k
...Contract Development and Manufacturing Organizations. It... ...closely with the Site Director, Microbiology staff,... ...her absence. Ensures compliance of the testing within... ...customers with understanding regulatory guidelines, test... ...with management. External contact may require...
Full time
Contract work
Monday to Friday
Eurofins USA BioPharma Services
North Brunswick, NJ
10 days 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
4 days ago
Operations Manager - Cranbury, NJ
...Shift(s) : Internal/External posting : AI Applicant... ...specifications, audits, and regulatory compliance. The Operations Manager is... ...REPORTS TO : Site Director ESSENTIAL ACCOUNTABILITIES... ...Solid understanding of Lean Manufacturing principles and concepts ·...
Contract work
Temporary work
Immediate start
Shift work
BelPak
Cranbury, NJ
27 days ago
Operations Manager
$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...
Immediate start
Monday to Friday
Flexible hours
Shift work
Night shift
Central Transport
New Brunswick, NJ
8 hours ago
Operations Manager-Pediatric And Orthodontic Dental Group
...provider scheduling and chair utilization. Manage budgets, payroll oversight, and operational expenses. Drive practice growth through strategic planning and execution. Maintain compliance with regulatory, safety, and company standards. Collaborate with ownership...
Temporary work
Work at office
THE SMILE EXPRESS PA
North Brunswick, NJ
9 hours ago
Director of Field Operations
$150k - $175k
...or an alternative application process. Director of Field Operations Full Time... ..., training, maintenance coordination, regulatory compliance, and process improvement initiatives while... ...RESPONSIBILITIES: Provides leadership and oversight to regional operations personnel and frontline...
Full time
Temporary work
For contractors
Work at office
Local area
Monday to Friday
Nsuwater
Hillsborough, NJ
1 day ago
Director, OT Cybersecurity & Manufacturing Resilience
...BD is seeking an Associate Director/Director of OT Cybersecurity Officer to lead global OT cybersecurity strategy, risk management, and governance across manufacturing and distribution environments. This leader will drive architecture, visibility, and secure operations...
Jobleads-US
Franklin, Somerset County, NJ
2 days 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
4 days ago
Executive Operations Coordinator
$55k - $75k
...Responsibilities: Operations management, workflow oversight, and process improvement. Revenue tracking, financial reporting... ...the Surrogate, county departments, community organizations, and external stakeholders. Inventory, procurement, and event resource management...
Work at office
Local area
Monday to Friday
Flexible hours
Weekend work
Middlesex County
New Brunswick, NJ
1 day 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. \n \n Core...
Contract work
Lupin Pharmaceuticals
Somerset, NJ
6 days ago
Executive Director, Cybersecurity Operations
...Executive Director, Cybersecurity Operations About the Company Prominent... ...track record in managing and providing oversight of critical vendors, as well as... ...leader with a detailed understanding of regulatory requirements, compliance, and industry standards in cyber...
Confidential
Iselin, NJ
5 days ago
Legal Operations Manager
$102k - $177.1k
...merit. Job Function Legal & Compliance Job Sub Function Legal Support... ...representative bodies, as may be required, regulatory approvals and other customary... ...would like to request an accommodation, external applicants please contact us via internal...
Contract work
Work at office
Local area
Immediate start
Johnson & Johnson MedTech
New Brunswick, NJ
2 days ago
Director, OT / Manufacturing Cybersecurity Officer
$192k - $307.2k
...us—from design and engineering to the manufacturing and marketing of our billions of MedTech... ...and operational excellence. Associate Director/Director, OT Cybersecurity Officer... ..., ISC, TDS, Digital, R&D, Quality, and Regulatory, the role sets OT security requirements...
Hourly pay
Daily paid
Temporary work
Remote work
Flexible hours
Shift work
Jobleads-US
Franklin, Somerset County, NJ
2 days 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...
Remote work
Nestlé
Bridgewater, NJ
26 days ago
Supervisor Production
...Description Jimmy's Gourmet Bakery is looking for an experienced Production Supervisor for our evening shift (3 PM -11 PM) to lead our manufacturing team in a fast-paced food production environment. This role is responsible for overseeing daily production operations, ensuring...
Hourly pay
Work at office
Shift work
Afternoon shift
Jimmy
South River, NJ
1 day ago
Supervisor, Freight Operations
$68.08k - $85.1k
...CCMTA, NSC and DOT policies, rules, regulations, and laws Implement all applicable workplace policies and procedures and enforce compliance to optimize network performance Ensure customer freight is processed, handled, loaded and delivered timely and damage free Coach...
Hourly pay
Work experience placement
Shift work
Night shift
Weekend work
Afternoon shift
XPO Logistics
East Brunswick, NJ
4 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... ...relationships with internal and external stakeholders. Ability to interact with...
Work at office
Worldwide
Shift work
Day shift
Afternoon shift
Legend Biotech
Raritan, NJ
17 hours ago
Director of Operations
...navigate emerging growth opportunities. The Director of Operations role at Lucosky Brookman... ...position is designed to bring strategic oversight and cohesion to our operations, ensuring... ...while protecting confidentiality and compliance. Process Improvement: Standardize...
Contract work
Afternoon shift
3 days per week
Crisp Recruit
Woodbridge, NJ
9 hours ago
Operations Manager
$145k - $195k
...May be responsible for multiple sites as well as mine sites. Provide management and direction of safety, environmental and regulatory compliance, operation, maintenance, technical and engineering support, long and short range planning, O&M resource plan, capital resource...
For contractors
Local area
Vistra
Sayreville, NJ
1 day ago
Publication Operations Manager II
$55 - $60 per hour
...direct client, a global pharmaceutical manufacturing client in Basking Ridge, NJ. \n \n... ...and drive the execution of internal and external scientific communication strategy and related... ...approvals. Ensure documentation of compliance with authorship and publication...
Hourly pay
Contract work
Temporary work
Work at office
Local area
Remote work
Source One Technical Solutions
Basking Ridge, NJ
4 days ago
Operations Manager
$85.6k - $141.7k
...management.What You'll Be Doing (And Doing Well!)Operational Oversight: Manage and supervise the day-to-day security operations across... ...maximize efficiency and maintain adequate coverage at all times.Compliance and Risk Management: Ensure compliance with all local and...
For contractors
Work at office
Local area
Shift work
Minuteman Security & Life Safety
Edison, NJ
1 day 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!