Job Description

ABOUT GLENMARK:

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 DESCRIPTION:

Under the direction of the Senior Director of Operations, the Operations Compliance Manager is responsible for Operations Trackwise document management inclusive of tracking and timely closure of Quality Exception/Investigation, CAPAs, Action Item and Change Controls. This position will have ownership of Operations Trackwise items, audit responses including internal, 3rd party and regulatory audit response items. In addition, this individual will own batch record review and delivery within the defined delivery timeline. This individual works closely with cross-functional teams at the site.

OVERALL JOB RESPONSIBILITIES:

Operations QMS items:

Manage scheduling, content and timely closure of deviations/investigation. Work with investigator and operations management for a complete and robust investigation with appropriate holistic and global CAPAs/Action Items to drive process and continuous improvement initiatives.

Internal Audits:

Schedule, execute internal audits, maintaining of reports related to site internal audits.

QMS Cycle Time:

Measure and drive QMS cycle time for triage completion, QE initiation, deviation/investigation closure, CAPA creation/closure. Reduce repeat QE items.

BPR Cycle time:

Develop metric and process for real-time batch record review. Work with Operations management to drive standard work batch records to reduce errors and improve BPR cycle time. Own the BPR cycle time metric with Operations.

Audits and Inspections:

Support audits / inspection processes, including, but not limited to: governmental, regulatory, Corporate audits and audit readiness related activities. Support external/regulatory audits / inspections when required.

Education:

Minimum Bachelor of Science (BS) / Bachelor of Arts (BA) on Science, Engineering, Pharmaceutical Sciences, or equivalent is required.

Experience:

Minimum 5 years in Operations or Quality Assurance in the pharmaceutical, biopharmaceutical, or medical device industry.

Knowledge and Skills :

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

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