Jobs in the United States

25+ jobs

Save this search

Added just now
Superintendent
Boldt
Whittier, CA · Los Angeles, CA · Irvine, CA
Project Locations: Los Angeles Metropolitan Area, CA
Added just now
EC
Asset Move Coordinator I - Relocation Project Coordinator
ENGICON CM
Los Angeles, CA
- $90,000 to $100,000 USD / year
Support the Furniture/Equipment/Relocation Project Management Services with emphasis in FF&E selection, procurement coordination and purchasing for all such areas as identified by the…
Added just now
Cost Accountant
TriMark USA
Lewisville, TX
The Cost Accountant is responsible for tracking, analyzing, and reporting on the cost of every project from quote through shipment. This role owns standard costs, job cost variance…
Added 1 min ago
A
Carpenter
Aerotek
Torrance, CA
- $30 to $35 USD / hour
…range of carpentry and general facilities maintenance tasks, support buildout and reconfiguration projects, and help ensure the site remains safe, functional, and well-presented. The…
Added 1 min ago
A
Cable Technician - Indianapolis
Aerotek
Fort Wayne, IN
- $20 to $35 USD / hour
Work EnvironmentYou will work in diverse commercial environments that vary by project, including bare-bones facilities undergoing large pre-wire installations and fully built sites that…
Added 1 min ago
Business Analyst III (US)
TD Bank, N.A.
Remote, United States
The Business Analyst III provides analytical and project management support to various corporate and business line strategic initiatives according to established Company procedures and…
Added 1 min ago
Store Manager I - Midtown/Raleigh
TD Bank, N.A.
Raleigh, NC
…developing skills and capabilities to achieve career goals, support project/initiative success and achieve business…
Added 1 min ago
Senior Auditor (US) - Financial Crimes
TD Bank, N.A.
NY
…retail, operational, platforms and tech, etc.), function or project and/or provides audit expertise and executes audit processes as part of a team or as an individual…
Added 1 min ago
TB
Store Manager III Full Time (Schuylerville/Throggs Neck)
TD Bank, N.A.
Bronx, NY
- Full-time
…developing skills and capabilities to achieve career goals, support project/initiative success and achieve business…
Added 2 mins ago
CO
Administrative Support Specialist - Innovation & Technology
City of Glendale (AZ)
Glendale, AZ
- $49,446.02 to $74,169.16 USD / year
…delivery and operations of vital IT infrastructure, computer support, IT governance, project management, as well as support and maintenance of enterprise applications, data analytics, GIS…
Added 2 mins ago
CO
Temporary Makerspace Program Assistant PT
College of Southern Maryland
Indian Head, MD
- $20 USD / hour
…motivated, organized, and creative Temporary Part-Time Makerspace Program Assistant to support the coordination, development, implementation, and growth of Makerspace programs and…
Added 3 mins ago
C
Full Stack Engineer, Business Applications & AI
Chowbus
Chicago, IL
- $100,000 to $130,000 USD / year
We’re hiring an engineer to help build the customer lifecycle project, a high-priority platform that streamlines and scales our internal business workflows, from restaurant onboarding to…
Added 3 mins ago
Technical Program Analyst - Security, Risk & Compliance
Visa Technology and Operations LLC
Austin, TX
· Program management and delivery of special CIO projects, as identified, to support security administration functions and processes.
Added 3 mins ago
Director - Sourcing and Procurement (Longview Capital Solutions)
BMO Bank N.A.
Irving, TX
Prepares and presents reports to business/group on key metrics and supplier risks to support better management of costs, risks, as well as provide input in business/group planning for…
Added 4 mins ago
NW Deployment Build Lead I, DCC Communities
Amazon Data Services, Inc.
Fairless Hills, PA
The position's responsibilities include capacity scaling support of several data center locations and day to day assistance with capacity management. You will work closely with internal…
Added 4 mins ago
Construction Program Manager
Ameresco Inc
HI
Ameresco is seeking a dynamic Construction Program Manager to lead implementation of large-scale federal energy projects in Hawaii. While the primary focus of this role will be project…
Added 4 mins ago
Environmental QC Manager
Ameresco Inc
CA
…Contractor-generated hazardous waste for characterization, container management and labeling, accumulation point inspections, storage, segregation, transportation, disposal, and…
Added 4 mins ago
CEC Technology Project Manager Sr
Flagstar Bank N.A
United States
Provides both verbal and written communications regarding project status, risks, and issues, and makes recommendations on project decision to Program Manager and Senior Management.
Added 4 mins ago
T
Project Manager, Wireless Site Development/Site Acquisition
TEKsystems
Phoenix, AZ
- $55 to $75 USD / hour
Site acquisition, Wireless Site Development, Wireless Deployment, Project Management, Vendor Management, Excellent Communication Skills, Organizational Skills, Risk Management,…
Added 4 mins ago
T
Project Architect (GIS)
TEKsystems
Denver, CO
- $75 to $85 USD / hour
The IT Architect is responsible for the technical alignment and quality of a major project within the Asset Data (GIS) organization. This role designs solutions that comply with enterprise…
Added 4 mins ago
T
Executive Communications Manager
TEKsystems
Dearborn, MI
- $50 to $65 USD / hour
…strategies. Provide counsel on sensitive communications, change management initiatives, organizational announcements, and business-critical messaging. Manage multiple high-priority projects…
Added 5 mins ago
DO
Hazardous Substances Engineer
Department of Toxic Substances Control
CA
- $6,488 to $12,152 USD / month
…environmental projects and special programs, including programmatic support and coordination of the Defense and State Memorandum of Agreement (DSMOA) program. This role manages complex…
Added 6 mins ago
Event Planner - Foundation Support
Metro National Corporation
Houston, TX
…donor appreciation events, and other community events that support MetroNational’s Community Affairs and Foundation programs and initiatives. This role primarily focuses on hands-on service…
Added 6 mins ago
Theater Security Cooperation Analyst- Shaw AFB, SC
Serco
Southern Pines, NC
…operational, and tactical objectives and coordinate programs that support objective accomplishment in support of the TSCP. Provide input to financial plan to support TSC program…
Added 6 mins ago
Supervisor - Fixed Asset
Old Dominion Freight Line
Thomasville, NC
…timely and accurate month-end and quarter-end reporting to…

Glenmark Pharmaceuticals Inc., USA

Manager -IPQA /QA Validation

Monroe, NC, United States

Apply About employer

Applications open in a new tab.

Job details

Education: Bachelor’s degree
Posting language: English
Posted: Nov 9, 2026

Original job description

POSITION SUMMARY

The Manager, IPQA/QA-Validation is responsible for providing leadership and strategic direction to the In Process Quality Assurance (IPQA) team and validation/qualification programs (including the Qualification/PM/Calibration of instruments, equipment, and facilities) ensuring alignment with corporate standards and regulatory guidance. The position will lead a team of In-Process Quality Assurance (IPQA) team providing oversight to QA aspects of Pharmaceutical Manufacturing including but not limited to shop floor activities like line clearances, walk throughs, documentation verification, IPQA checks for manufacturing and packaging processes, AQL, BPR revision, sample management, retain samples program, visual inspection program and notification of hold for equipment, rooms, utilities etc. Additionally, person in this role is responsible QA validation team for the support of facility start-up activities, technical transfers, requalification’s and routine activities validation activities as they pertain to Manufacturing, Maintenance and Warehouse functions.

JOB RESPONSIBILITIES

Responsibilities

Results Expected/ Target

Financial

Support in Preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation and management within approved budgets while building best in class quality processes and systems at the site

Operational Excellence

Responsible for overall management of IPQA/QA-Validation activities
Manage the validation system from a Quality Assurance perspective
Oversee sampling process for in-process, finished product, stability, and retention samples for the development, commercial, and validation batches
Act as the IPQA /Validation SME for Change Controls and Investigations supporting GMP/GLP systems.
Ensure required Standard Operating Procedures and systems are implemented to support manufacturing and validation programs.
Quality oversight and approval of software, equipment/facility qualification, IQ/OQ/PQ protocols and reports and associated change control systems.
Report validation/qualification quality issues and trends to management.
Provide leadership and guidance to staff on qualification/validation aspects.
Review and revise SOPs for consistency and compliance with regulatory requirements
Providing oversight to analytical labs for instrument qualifications.
Providing training to team personnel and managing to meet goals established
Provide leadership, mentoring, and development opportunities for the staff.
Maintain visual inspection qualification program including AQL for the products

Stakeholder

Support regulatory inspections by FDA and foreign regulatory agencies
Participates in continuous improvement efforts in quality systems through the evaluation of trends in key performance indicators, audit and stakeholder feedback, and corrective/preventative actions.
Participate in cross-functional risk assessments and process parameter classification
Provide hands-on review and subject matter expertise of Validation lifecycle documentation including Process Design Documents, Process Control Strategy, Master Plans, Protocols and Reports
Ensure GMP compliance at the shop floor as per respective SOP
Provide quality oversight and support for process, cleaning, shipping, computer system, equipment and instrument qualification and validation activities
Participate on interdepartmental project / program teams to meet company / site milestones and objectives

Innovation

Stay abreast of industry and affiliated publications, memberships, and technologies to ensure organizational goals are met. Actively seek out new, cutting-edge technology to further Quality Operations initiatives and build efficiencies
Ensure compliance with current U.S. and EU cGMP regulations and industry standards
Apply risk based methodologies in the oversight of validation efforts and CSV activities

KNOWLEDGE, SKILLS AND ABILITIES

Education (degree / diploma)

A minimum of a Bachelor’s degree in Pharmaceutical Science or Engineering associated fields is required

Experience

6-8 years of experience in Quality Assurance or Design Assurance in the Pharmaceutical, Biotech, medical device industry (or related industry), or experience in related engineering areas, e.g. R&D or Manufacturing
Advanced degrees may be used to reduce required experience

Knowledge and Skills (Functional / Technical)

Extensive knowledge of quality tools:
CGMP
Validations and Qualifications
Regulatory guidelines
US Pharmacopoeias
Internal auditing
Handling of regulatory Inspections
Well acquainted with QMS and CSV
Well versed with Change control/deviations and market compliant management system.
Strong understanding of Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Good Documentation Practices (QDP); and ICH Q8, Q8, and Q10 procedures
Proficiency with Microsoft Word, Microsoft Excel, and Power Point is required. Strong documentation skills are required.
Experience with comparative Statistical techniques, sampling plans, GR&R, hypothesis testing, ANOVA, parametric and non-parametric analysis are also desired.

Leadership / Managerial Attributes

The ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required.
This candidate must be a technical expert and have excellent written and oral communication and interpersonal relationship skills.

Other requirements (licenses, certifications, specialized training)

Certified Lean Six Sigma Green Belt or Black Belt and/or Certified Quality Engineer (CQE), ASQ is preferred

Apply About employer

Report this job