Jobs in the United States

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Added 1 min ago
Product Marketing Manager
Applied Materials
Gloucester, MA · Gloucester
…the foundation of virtually every new semiconductor chip and advanced display in the world. The equipment that we create and service is essential to advancing AI and accelerating the…
Added 1 min ago
Paralegal V – Commercial Contracts (Contracts Manager)
Applied Materials
Santa Clara, CA · Washington, DC · Austin, TX · Santa Clara · Washington · Austin
…the foundation of virtually every new semiconductor chip and advanced display in the world. The equipment that we create and service is essential to advancing AI and accelerating the…
Added 1 min ago
E
Director, Payload Electronics, Space Communications Systems
E-Space
Santa Clara, CA · Saratoga, CA · Arlington, TX
- $140,000 to $210,000 USD / year
…Things (IoT) solutions and services. We are building a highly-advanced low Earth orbit (LEO) space system that will fundamentally change the design, economics, manufacturing and service…
Added 3 mins ago
Project Portfolio - Cost Analyst - Lead
Tallgrass
Houston, TX
Develop, implement, and maintain cost control measures, reports, cash flows and forecasts on specific Projects and Programs.
Added 3 mins ago
Senior Product Manager, Mobile Apps – Vehicle Productivity and Electrification Experiences
Ford Global
Remote, United States
…help us redefine the future of mobility. As a Digital Product Manager at Ford, you will work cross-functionally to ensure the products we build will meet and elevate our customers’…
Added 4 mins ago
Loan Support Analyst - Document Control Center
PNC Bank NA
PA
…doula reimbursement; educational assistance, including select programs fully paid; a robust wellness program with financial…
Added 4 mins ago
Senior Director, GCS Early Pipeline and Business Development
Vertex US Distribution
Boston, MA
…assets, and enable rapid, informed development decisions when a program is ready to enter the…
Added 4 mins ago
Business Analytics Consultant Senior - Real Estate Market Analytics
PNC Bank NA
PA · Chicago, IL · East Brunswick, NJ · Cleveland, OH
…doula reimbursement; educational assistance, including select programs fully paid; a robust wellness program with financial…
Added 4 mins ago
Relationship Manager, II Business Banking
PNC Bank NA
Monroeville, PA
…doula reimbursement; educational assistance, including select programs fully paid; a robust wellness program with financial…
Added 4 mins ago
Technology Risk Advisor Sr
PNC Bank NA
PA · Phoenix, AZ · Dallas, TX
Shapes and drives the planning and execution of the technology risk management program and associated communication strategies. Leverages advanced subject matter
Added 5 mins ago
Project Portfolio - Cost Analyst - Lead
Tallgrass
Houston, TX
Develop, implement, and maintain cost control measures, reports, cash flows and forecasts on specific Projects and Programs.
Added 6 mins ago
Team Coordinator
Agape Care Group
Orangeburg, SC
…employees are committed to serving with love those touched by an advanced illness, providing comfort and support through compassionate care and meaningful experiences. At any location…
Added 6 mins ago
Technology Risk Advisor Sr
PNC
Pittsburgh, PA · Phoenix, AZ · Denver, CO · Strongsville, OH · Dallas, TX
Shapes and drives the planning and execution of the technology risk management program and associated communication strategies. Leverages advanced subject matter
Added 6 mins ago
Relationship Manager, II Business Banking
PNC
Monroeville, PA
…doula reimbursement; educational assistance, including select programs fully paid; a robust wellness program with financial…
Added 7 mins ago
Confocal Sales Specialist
Danaher
Seattle, WA · Denver, CO · Portland, OR · Salt Lake City, UT
Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid…
Added 10 mins ago
Da Vinci Specialist - Phoenix West
Intuitive
Remote, United States
…specifically the Clinical Sales Representative and Clinical Sales Manager, to ensure safe and effective product adoption and quality control while driving positive patient…
Added 10 mins ago
Mission Management Program Manager
Astranis
San Francisco, CA
The Mission Management Program Manager will be responsible for coordinating the end-to-end execution of assigned missions across these organizations. This role will establish integrated…
Added 12 mins ago
Program Services Business Analyst
Berkley
Hamilton Square, NJ
The Business Analyst (BA) for the Program Services Team is responsible for assessing and documenting the group’s workflow and systems needs to support the operations and growth of the…
Added 14 mins ago
Technology Strategy Technical Lead
McLean, VA
Partner with cloud, platform, data, and security teams, and with the GenAI Program Manager, to integrate GenAI services with enterprise systems, translate business needs into governed…
Added 15 mins ago
Executive Assistant
United Services Automobile Asn
United States
Partners with hiring manager to improve employee experience by proactively planning and onboarding new EMG or other team members. Collaborates to formulate an effective transition plan that…
Added 16 mins ago
Cost Accountant
TriMark USA
Lewisville, TX
The Cost Accountant reports to the General Manager
Added 17 mins ago
BM
Service Manager
BH Management
Jacksonville, FL
- $34 USD / hour
…Participates in the site staffing needs with the Community Manager. Assesses training needs of employees, provides input for needed training programs, coordinates and schedules appropriate…
Added 17 mins ago
Finance Manager - FP&A
TD Bank, N.A.
Mount Laurel, NJ
The Finance Manager provides a range of strategic Finance advice, analysis and support for key business areas/portfolios as assigned. Proactively manages senior relationships in order to…
Added 17 mins ago
Relationship Banker II (Olney)
TD Bank, N.A.
Olney, MD
…uncovering both expressed and unexpressed client needs through advanced questioning and active…
Added 17 mins ago
IT Solutions Architect (US)
TD Bank, N.A.
Mount Laurel, NJ · Charlotte, NC · Fort Lauderdale, FL
Advanced knowledge of the business , technical environment, processes, tools, various and multiple programming languages, operating systems, solutions design and other relevant technology…

Glenmark Pharmaceuticals Inc., USA

Manager -IPQA /QA Validation

Monroe, NC, United States

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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

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