Open To Work
ROBERT HOUGH
Bayville,NJ
Summary
Dynamic leader in pharmaceutical compliance, specializing in regulatory documentation and SOP governance. Expertise in managing state and federal licensing processes while driving quality improvements through CAPA and deviation management. Committed to fostering a culture of compliance through effective training and cross-functional collaboration.
Overview
30
30
years of professional experience
1
1
Certification
Work History
Operations Compliance Manager
R & S Northeast
Greater Philadelphia Area
01.2020 - 01.2026
- Directed all State and Federal licensing activities for three facilities, ensuring uninterrupted operational compliance.
- Managed regulatory communications, ensuring accurate and timely documentation and reporting.
- Directed SOP governance, overseeing authorship, revision, and change control to ensure compliance consistency.
- Enhanced compliance infrastructure through improvements to Suspicious Order Monitoring System (SOMS), reinforcing operational integrity.
- Drove quality improvement through deviation and CAPA oversight.
- Built and delivered training programs supporting compliant operations and employee readiness.
Senior Compliance Specialist
Taro Pharmaceuticals
Cranbury, NJ
01.2018 - 01.2020
- Managed regulatory documentation and compliance submissions for distribution and operational activities to ensure adherence to industry standards.
- Delivered compliance training and maintained licensing and documentation for import/export and distribution to support regulatory readiness.
- Implemented site-wide monitoring enhancements to improve compliance controls.
- Led SOP and Change Control updates aligned with evolving quality requirements.
- Supported investigations, deviations, and CAPAs to maintain operational integrity.
Regulatory Compliance Specialist
Aurobindo Pharma USA, Inc.
Dayton, NJ
01.2017 - 01.2018
- Oversaw accountability documentation for manufacturing and API operations, ensuring compliance with regulatory standards.
- Managed licensing and documentation across manufacturing, R&D, analytical, and distribution functions to support compliance and operational integrity.
- Served as primary compliance liaison, overseeing official documentation and facilitating communications to ensure regulatory adherence.
- Managed multi-state distribution reporting and documentation for material disposition.
- Delivered weekly compliance orientation and supported ongoing training initiatives.
- Authored SOPs, created Change Controls, and supported site investigations.
Quality Assurance & Operations Roles
Renaissance Pharmaceuticals
Lakewood, NJ
01.2014 - 01.2017
- Led QA programs, implemented GMPs, authored SOPs, and ensured compliance in government-regulated manufacturing.
- Conducted in-process inspections, executed documentation audits, and performed environmental monitoring to maintain quality standards.
- Managed training programs and documentation workflows, coordinating cross-functional efforts to enhance operational effectiveness.
- Supported product development, inventory systems, and operational readiness across multiple regulated environments.
Quality Assurance & Operations Roles
TPS Associates, Inc.
Manchester, NJ
01.2004 - 01.2013
- Implemented Good Manufacturing Practices in manufacturing department resulting in sales ranging from 6 to 13 million dollars annually Wrote all manufacturing records and standard operating procedures for manufacturing activities set to Government QAR requirements Provided written progress reports to TPS management and Government clients and customers Evaluated Engineering Change Proposals and communicated with system engineers to resolve any resulting technical conflicts Established training, development, and delivery timelines for direct reports Provided TPS Management and Government clients with accurate cost estimates and delivery schedules for technological assets and support equipment Collaborated with program managers and engineers to develop new products based on Government inquiries Marketed and launched new products for Government clients Designed and created electronic and print Marketing materials for manufacturing and support services provided by TPS Associates Procured parts and components to specified bills of materials Created and controlled a complete inventory system for all manufacturing parts and components Acted as TPS liaison to third party consortium members involved in manufacturing support equipment and devices
- Executed operational tasks in manufacturing department, ensuring adherence to quality standards.
- Proposed strategies that enhanced team effectiveness and contributed to successful project outcomes.
- Collaborated with diverse team to meet project objectives and address product-related challenges.
Quality Assurance & Operations Roles
Vivus Inc.
Lakewood, NJ
01.1998 - 01.2002
- In-process inspections of raw materials, components, and retains Pulling samples and retains from in process as well as finished products Ensuring all production activities and personnel are in compliance with standard operating procedures and GMPs Maintaining proper documentation in accordance with GMPs Auditing all manufacturing documentation including batch records, forms, and logbooks for accuracy and compliance with standard operating procedures both during and upon completion of manufacturing activities Staging and inspection of all manufacturing machinery and components Inspecting and approving all manufacturing lines prior to use and upon completion of production activities Participated in procedural reviews with QA and Production supervision to update and create Standard Operating Procedures Reviewed Manufacturing records for product release Performed cleaning validations and Environmental Sampling in aseptic clean rooms Developed system for review and retention of environmental graph charts for environmentally controlled areas of facility Performed investigations of deviations and non-conformant situations Training newly hired QA inspectors
- Executed daily operational tasks with precision and timeliness.
- Proposed strategies that enhanced team efficiency and improved overall results.
- Collaborated with diverse teams to achieve objectives and address product-related challenges.
Quality Assurance & Operations Roles
Cordis (Johnson & Johnson)
Warren, NJ
01.1996 - 01.1998
- Applying cardiac stents to balloon catheters in an ISO Certified Life Science facility clean room environment Training new technicians and updating training on existing technicians in Good Manufacturing Practices, Good Laboratory Practices, and Good Clinical Practices and assembling medical devices Providing Quality Assurance with product and packaging samples and documents in accordance with Good Manufacturing, Laboratory, and Clinical Practices. Performing seal integrity testing on all packaging equipment daily and logging test samples in Quality Assurance in accordance with Good Laboratory Practices
- Executed daily responsibilities with precision in fast-paced environment, ensuring compliance with quality standards.
- Collaborated with diverse team to meet objectives and address product-related challenges, contributing to successful project completion.
- Proposed strategies that enhanced team effectiveness and improved project outcomes.
Education
Bachelor of Arts - Business Management
American Intercontinental University
Indiana06-2008
Skills
- Regulatory compliance
- Regulatory submissions
- Compliance oversight
- GMP, GLP, GCP compliance
- Audit readiness
- CAPA and deviation management
- Change control management
- Risk assessment and project management
- Vendor management
- Cross-functional collaboration
- SOP governance
- Onboarding training
- Program design and effective communication
- Inventory accountability documentation
Core Competencies
State licensing, Regulatory submissions, Compliance documentation, Registration oversight, SOP governance, Change Controls, CAPA/deviation management, GMP/GLP/GCP compliance, Audit readiness, Process improvement, Compliance monitoring, Cross-functional collaboration, Inventory/accountability documentation, New-hire onboarding, Compliance training, Program design, Team guidance
Certification
- Wholesale Distributor Licensed Designated Representative for Florida and California
Work Preference
Job Search Status
Open to workSalary Range
$80000/yr - $200000/yrTimeline
Operations Compliance Manager
R & S Northeast
01.2020 - 01.2026
Senior Compliance Specialist
Taro Pharmaceuticals
01.2018 - 01.2020
Regulatory Compliance Specialist
Aurobindo Pharma USA, Inc.
01.2017 - 01.2018
Quality Assurance & Operations Roles
Renaissance Pharmaceuticals
01.2014 - 01.2017
Quality Assurance & Operations Roles
TPS Associates, Inc.
01.2004 - 01.2013
Quality Assurance & Operations Roles
Vivus Inc.
01.1998 - 01.2002
Quality Assurance & Operations Roles
Cordis (Johnson & Johnson)
01.1996 - 01.1998
Bachelor of Arts - Business Management
American Intercontinental University