Jobs in the United States

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CO
Associate Civil Engineer (Development Services)
City of Sacramento
Sacramento, CA
- $47.05 to $66.2 USD / hour
Coordinate with the project manager, inspectors, various staff, external agencies, and vendors. Provide direction and technical support to project manager, inspectors and contractors.
Added 1 hour ago
Project Manager
Confluence Health
Wenatchee, WA
The Project Manager (PM) is a core member of the Confluence Health Project Management Office, responsible for leading capital construction, facilities, operational, and IT initiatives…
Added 3 hours ago
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Senior Program Manager
Astrion
Bedford / Hanscom AFB, MA
- $150,000 to $170,000 USD / year
Astrion has an exciting opportunity for a Senior Program Manager to support the Survivable Airborne Operations Center (SAOC) Division at Hanscom AFB, MA.
Added 3 hours ago
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Program Manager SME
Astrion
Bedford / Hanscom AFB, MA
- $150,000 to $175,000 USD / year
Astrion has an exciting opportunity for a Program Manager SME to support the Survivable Airborne Operations Center (SAOC) Division at Hanscom AFB, MA.
Added 3 hours ago
SANs FISMA Consultant
COOLSOFT
Columbia, SC
Utilize Microsoft Office software suite, System Center Service Manager (Ticketing system), Archer eGRC system, Bizagi, Atlassian and other products to document and report on information…
Added 4 hours ago
Electrical Trades III - Greeley
State of Colorado
Greeley, CO
…professional development. Perks include Colorado Employee Assistance Program (CSEAP) counseling, wellness, credit union membership and employee discount program. Visit CDOT Benefits for…
Added 4 hours ago
SO
Accounting Supervisor (Accountant III) - Denver
State of Colorado
Denver, CO
- $83,664 to $96,204 USD / year
…professional development. Perks include Colorado Employee Assistance Program (CSEAP) counseling, wellness, credit union membership and employee discount program. Visit CDOT Benefits for…
Added 4 hours ago
SO
Professional Land Surveyor - Metro Denver
State of Colorado
Denver, CO
- $86,544 to $88,572 USD / year
…Denver. This unit supports the delivery of the Right-of-Way (ROW) program for the development and maintenance of the State Transportation System in the Denver Metro…
Added 4 hours ago
SO
Accountant III, Fixed Assets - Denver
State of Colorado
Denver, CO
- $83,664 to $96,204 USD / year
…implementing Fixed Asset fiscal and GASB rules in the SAP financial system. This position additionally focuses on Inventory Oversight, Reconciliations and Internal Control and provides…
Added 5 hours ago
MS Federal Project Manager
Hewlett Packard Enterprise
Alpharetta, GA
We are seeking a Managed Services Federal Project Manager (PM) to drive projects, operations, and execution of a secure cloud environment in the federal space. This role is responsible for…
Added 6 hours ago
Cons - T.C. - SAP - Supply Chain Mgmt. – OTC - Eng & Systems Integration (Mgr.)(Mult Pos)(1758174)
Ernst & Young US LLP
Cincinnati, OH
Consulting - Technology Consulting - SAP - Supply Chain Management -- OTC - Engineering & Systems Integration (Manager) (Multiple Positions) (1758174), Ernst & Young U.S. LLP, Cincinnati,…
Added 7 hours ago
Technical Project Manager - Blue National Security
Blue Origin Personnel, LLC
Denver, CO
…interdisciplinary team of engineers, procurement professionals, and program managers, you will serve as the primary technical interface between Blue Origin and our critical Tier 2/3…
Added 8 hours ago
Manager -IPQA /QA Validation
Glenmark Pharmaceuticals Inc., USA
Monroe, NC
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…
Added 8 hours ago
SC
Transit Service Planning Manager
Santa Clara Valley Transportation Authority
San Jose, CA
- $82.45 to $100.21 USD / hour
…and Transportation Forecasting & GIS. The Service Planning Manager is part of the Transit Planning functional area, which is organized into three closely coordinated teams: Transit Service…
Added 8 hours ago
SC
BSVIII Senior Business Systems Analyst
Santa Clara Valley Transportation Authority
San Jose, CA
- $63.7 to $82.8 USD / hour
Are you looking for a challenging career opportunity where you can collaborate with a team of technical and subject matter experts for program & project management, engineering, and…
Added 8 hours ago
Digital Health (Initiative 6) Lead, NCRHTP
Health & Human Services
Wake County, NC
The Digital Health Initiative 6 Lead serves as the statewide program manager responsible for designing, coordinating, and implementing digital health transformation activities for the North…
Added 9 hours ago
SO
Social Service Counselor 4A
State of Louisiana
Elmwood, LA
- $21.46 to $38.67 USD / hour
Consults with Clinical and Support Services Manager (CSSM) for any and all clinical matters that arise with program
Added 9 hours ago
HS
Deputy Program Manager
HunaTek System Solutions
Colorado Springs, CO
- $140,000 to $165,000 USD / year
The Deputy Program Manager will serve as the Program Manager's principal deputy and will support the leadership and execution of an approximately 400-person, multi-site technical…
Added 9 hours ago
Lead Systems Administrator
S&C Minimal
Chicago, IL
Assist the manager in developing short-term and long-term technology roadmaps, including infrastructure lifecycle planning, refresh planning, modernization priorities, capacity forecasting,…
Added 9 hours ago
MC
Customer Service Controls Engineer
Mikron Corporation Denver
Englewood, CO
- $80,000 to $100,000 USD / year
Contribute to the proper design of Mikron Corporation Denver (MDE) control systems. Program the control system and test using Mikron processes and rules. Participant in onsite installs and…
Added 9 hours ago
MC
Customer Service Controls Engineer (Travel)
Mikron Corporation Denver
Englewood, CO
- $90,000 to $110,000 USD / year
Contribute to the proper design of Mikron Corporation Denver (MDE) control systems. Program the control system and test using Mikron processes and rules. Participant in onsite installs and…
Added 9 hours ago
SO
Administrative Assistant (Substitute) (DS - Risk Mgmt)
South Orange County Community College District
Mission Viejo, CA
- $30.01 USD / hour
Under direction from an appropriate level manager or administrator of record of a single-function program of moderate size, staff, budget, and complexity or the Dean of a large…
Added 10 hours ago
Instrumentation Controls & Power Generation Manager
Louis Dreyfus Company
Grand Junction, IA
This position will be a technical manager and leader of the resources at LDC Grand Junction, for overseeing all instrumentation and control activities at the site including real time health…
Added 10 hours ago
SO
CDOC General Maintenance Electrician Supervisor CSTS I (Sterling)
State of Colorado
Sterling, CO
- $5,081 to $7,113 USD / month
Distinctive career advancement opportunities throughout the state system
Added 10 hours ago
SO
CDOC Licensed Boiler Operator Supervisor CSLTS I (Sterling)
State of Colorado
Sterling, CO
- $5,336 to $7,469 USD / month
Distinctive career advancement opportunities throughout the state system

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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