QA Director - Site Investigations & Quality systems

Quality Assurance Manager

Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules both New Chemical Entities (NCE's) 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 researchbased pharmaceutical company.

Position Summary :

This position is responsible for overall adequacy of all non-conformances investigations logged at site in respect to local and global procedures as applicable. Ensures that the non-conformances are thoroughly investigated, root causes are substantiated, adequate and effective CAPA's are implemented. Is able to identify any atypical product quality trend and escalate in a timely manner to site and corporate level. This position will be an extension to implement corporate investigation and harmonization strategies and will represent the Monroe site. Has been involved in handling USFDA inspections, responding to observations and well versed with Regulatory requirements. Under the direction of the Senior Director of Quality, this position is also responsible for implementing and managing the systems related to GxP compliance which includes, but is not limited to, the following systems : Document Control, Electronic Quality Management Systems (Investigation, Change Control, CAPA) and Annual Product Review (APR).

Job Responsibilities :

Financial :

• Participate in preparation of Revenue and Capex Budget. Ensure financial prudence in resource planning, allocation, and management within approved budgets while building the site's best-in-class quality processes and systems.
• Maintain quality system controls to ensure no critical and major market complaints.

Operational Excellence :

Stakeholder :

Innovation :

Knowledge, Skills and Abilities :

Education :

Bachelor of Pharmacy or relevant science degree

Knowledge and Skill :

15-25 years in Pharmaceutical Industry - Investigations, Sterile Manufacturing Quality Assurance, Validation and Qualifications, Quality System and Compliance, Auditing, Good Distribution Practices, Sales and marketing

Knowledge and Skill :

Leadership / Managerial Attributes :