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QA Director – Site Investigations & Quality systems Jobs in Monroe, North Carolina, USA at Global Blockchain Talent
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QA Director – Site Investigations & Quality Systems
Glenmark Pharmaceuticals Inc., USA, is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in discovering new molecules – both New Chemical Entities (NCEs) and New Biological Entities (NBEs), with eight molecules in various stages of clinical development. Glenmark USA is a fast-growing, robust generics business with plans to expand into the innovative market. The subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark employs over 10,000 people across more than 60 countries, including twelve manufacturing facilities, five R&D centers, and offices in the US, EU, India, and Brazil.
Glenmark is currently experiencing significant growth in the U.S. and internationally, positioning itself as a potential leading research-based pharmaceutical company.
Position Summary:
This role oversees the investigation of all non-conformances logged at the site, ensuring compliance with local and global procedures. It involves thorough investigation, root cause analysis, and implementation of effective CAPAs. The director will identify atypical product quality trends and escalate issues appropriately, representing the Monroe site in implementing corporate investigation strategies and harmonization efforts.
Experience with USFDA inspections, responding to observations, and familiarity with regulatory requirements are essential. Under the guidance of the Senior Director of Quality, the role also manages systems related to GxP compliance, including Document Control, Electronic Quality Management Systems (Investigation, Change Control, CAPA), and Annual Product Review (APR).
Job Responsibilities:
Participate in budget planning, resource management, and process/system improvements.
Maintain quality controls to prevent critical and major market complaints.
Operational Excellence:
Manage QMS documents like investigations, change controls, and APR.
Review of OOS, OOT, incident deviations, and CAPA documents.
Conduct root cause analysis using tools like Fishbone diagrams, ‘5 WHYs’, and process mapping.
Assess CAPA effectiveness and respond to audit observations.
Represent the site during regulatory inspections and audits.
Identify and escalate atypical product quality trends.
Develop and improve quality procedures and global policy implementation.
Stakeholder Coordination:
Coordinate with Production, R&D, QA, QC, Validation, and IT teams.
Lead APR activities and review SOPs across departments.
Ensure compliance with cGMP, 21
CFR, USP, EP, and ICH standards.
Knowledge, Skills, and Abilities:
Education: Bachelor of Pharmacy or relevant science degree.
Experience: 15-25 years in pharmaceutical investigations, sterile manufacturing quality assurance, validation, compliance, and related areas.
Skills:
Effective communication, interpersonal skills, and statistical data evaluation.
Change management, project leadership, and opportunity leveraging abilities.
Technical expertise in lab and manufacturing operations, product development, validation, and investigations.
Leadership Attributes:
Timely escalation and decision-making capabilities.
Results-driven with accuracy under deadlines.
Effective communication across organizational levels and team environments.
Specialized training in investigations is a plus.
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Title: QA Director – Site Investigations & Quality systems
Company: Global Blockchain Talent
Location: Monroe, North Carolina, USA
Category: Quality Assurance – QA/QC (Data Analyst)
