Quality Compliance Specialist

Global Blockchain Talent; Monroe (NC); On-site; USD 60,000 - 90,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen Quality Compliance Specialist, um die Qualitätssysteme zu verwalten und die Einhaltung regulatorischer Anforderungen sicherzustellen. In dieser Rolle werden Sie eng mit funktionsübergreifenden Teams zusammenarbeiten, um Beschwerden zu bearbeiten, Audits durchzuführen und kontinuierliche Verbesserungen voranzutreiben. Sie werden die Möglichkeit haben, an spannenden Projekten zur Verbesserung der Qualität und Effizienz am Standort teilzunehmen. Wenn Sie eine Leidenschaft für Qualitätssicherung in der pharmazeutischen Industrie haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Mindestens 3 Jahre Erfahrung in der Qualitätssicherung in der pharmazeutischen Industrie.
• Starkes Verständnis der aktuellen GMPs und regulatorischen Anforderungen.

Responsibilities

• Verantwortlich für die Verwaltung von Qualitätsbenachrichtigungen und Audits.
• Unterstützung bei der Planung und Verwaltung von Ressourcen innerhalb genehmigter Budgets.

Skills

Qualitätskontrolle

GMP-Kenntnisse

Analytische Fähigkeiten

Projektmanagement

Kommunikationsfähigkeiten

Education

Bachelor of Science (BS) oder Bachelor of Arts (BA)

Tools

Excel

Minitab

Job description

Career Opportunities with Glenmark Pharmaceuticals Inc.

A great place to work.

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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules – both New Chemical Entities (NCEs) and New Biological Entities (NBEs), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast-growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.

Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.

Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research–based pharmaceutical company.

POSITION SUMMARY:

Under the direction of the Senior Manager, Quality Compliance, the Quality Compliance Specialist is responsible for managing the investigation and resolution of Quality Systems notifications including, but not limited to: Complaints, Field Alerts and Recalls, Vendor and Contract Lab Qualifications, Internal and External Audits. This individual works closely with cross-functional teams at the site and abroad. They will routinely report on system and business process performance, proactively identify, provide guidance, and implement process and system improvements to resolve complex issues in a timely manner. This position also provides site representation for regulatory surveillance programs.

JOB RESPONSIBILITIES:

Provide support in resource planning, allocation, and management within approved budgets while building best-in-class quality processes and systems at the site.

Operational Excellence:

• Ensure complaints are logged, triaged, investigated, and resolved according to established deadlines, company, and regulatory requirements.
• Coordinate reviews of relevant records (e.g., batch records, quality control data, quality investigations, etc.).
• Track quality system metrics related to complaints and create detailed trend analysis reports. Prepare formal reports for complaint closure.
• Ensure site compliance with CGMPs concerning internal/external regulations and procedures.
• Support evaluation and implementation of Global Policies and Procedures.
• Assist in evaluating and implementing new changes for the site.
• Support projects aimed at improving site quality and efficiency.
• Maintain records for internal and external audits, including vendor and CTL audits, along with scheduling.
• Participate in regulatory surveillance programs and collaborate with CFT members to implement necessary changes to prevent observations.
• Support handling of Field Alerts and Product Recalls for marketed products.
• Approve creation or modification of Materials and Vendors.
• Create or modify Quality view data such as shelf life and Quality Info Record (QIR) based on vendor qualification status.
• Support audits and inspections, including governmental, regulatory, corporate, or vendor audits, and related activities.
• Assist in audit readiness and responses.

Stakeholder:

• Ensure site compliance with CGMPs and regulations.
• Guide and collaborate with stakeholders across departments to process complaints, manage audit CAPAs, and follow up for audit closure.
• Support Annual Product Review activities.
• Establish, revise, and improve procedures for Quality Systems.
• Develop and monitor KPIs for the functional area, ensuring systems operate within targets.

Education:

Bachelor of Science (BS) or Bachelor of Arts (BA) in Science, Engineering, Pharmaceutical Sciences, or equivalent.

Experience:

Minimum 3 years in Quality Assurance within the pharmaceutical, biopharmaceutical, or medical device industry, or a combination of education and experience.

Knowledge and Skills:

Strong understanding of current GMPs and related regulatory health authority guidance (FDA regulations, ICH guidelines, etc.). Proactive, results-oriented, with excellent attention to detail and time management skills.

Ability to manage multiple projects, meet deadlines, and adapt to a fast-paced environment.

Analytical skills for decision-making, excellent communication skills in English, and strong interpersonal skills.

Intermediate skills in Excel and/or Minitab, including data manipulation, charting, and analysis.

Ability to work independently or in a team, handle multiple priorities, and exercise good judgment.