Glenmark Pharmaceuticals · 2 days ago
Quality Systems Specialist
Monroe, NC
Full-time
Onsite
Mid Level
3+ years expGlenmark Pharmaceuticals Inc., USA is a leading player in the discovery of new molecules and is fast growing in the US generics business. The Quality Systems Specialist will manage the elements of Quality Systems, ensuring compliance with regulations while implementing process improvements and supporting cross-functional teams.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide support in resource planning, allocation and manage within approved budgets while building best in class quality processes and systems at site
Ensures investigations are logged, triaged, investigated, and resolved according to established deadlines, company and regulatory requirements
Coordinates with cross-functional teams for testing of reserve or retain samples for investigation purposes, where applicable
Coordinates the reviews of relevant records, (e.g. batch records, quality control data, quality investigations, etc.)
Conducts root cause analysis in order to facilitate and initiate corrective and preventative actions wherever needed
Tracks quality system metrics and creates detailed trend analysis reports
Performs analysis of data, trending and provides metrics for Quality Systems, as required
Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures
Coordinates evaluation of implementation for Global Policies and Procedures
Evaluates and assists in the implementation of new changes for the site
Supports implementation of projects that improve site Quality and/or efficiency
Assess changes in terms of their impact to CGMP and using Risk Management tools
Prepares and compiles the required data to support the APR submission for the products manufactured on site
Provide support to collect and prepare QMR board presentation and associated documentation
Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures
Provide guidance and work with stakeholders from various departments to process Investigations, CAPA, Change Controls, Deviations
Coordinate and collect information from departments for performing QMR and annual product review
Establish, revise, review and continuously improve procedures for all Quality Systems
Establish Key Performance Indicating (KPIs) for functional area and ensure systems are operating within target
Qualification
Required
Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent
Minimum 3 years in Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience
Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.) as they relate to the pharmaceutical industry
Must be proactive, results-oriented with a strong attention to detail and strong time management skills
Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever-changing, fast-paced critical work environment
Ability to analyze details and perform structured decision-making on a daily basis
Excellent verbal and written communication/documentation skills. Must be able to read, write, and speak English
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner
Intermediate Excel and/or Minitab skills are required including, but not limited to: spreadsheet manipulation, charting, and analysis tools
Ability to work independently, or within a team structure, and on multiple projects, with flexibility to adapt to changing priorities is required
Self-starter with the ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team
Preferred
Any quality or lean/Six Sigma certifications are a plus
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
H1B Sponsorship
Glenmark Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2023 (1)
2022 (4)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
2025-12-24
Business Standard India
2025-12-17
Company data provided by crunchbase