QA Director - Site Investigations & Quality systems

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 research–based 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:

• Handling of QMS documents like Quality Event/ deviation investigation, Change Control, APR etc.
• Review of QMS documents such as OOS, OOT, Incidents deviation, CAPA
• Performing Root Cause Analysis of an occurred OOS, deviation/ a typical event of or Failure investigation using investigation tools viz. Fishbone diagram, ‘5 WHY’ Analysis, IS – IS NOT Analysis, Peeling the Onion, Process Mapping / Flow Charts, Interviews and brain storming
• Reviewing the adequacy of CAPA’s with respect to the root cause investigations. To verify if the CAPA effectiveness check is well defined
• Responding to Internal and external audit observations with respect to investigation related observations. Serve as site representative for Quality Systems during regulatory inspections and corporate audits
• To be able to identify and notify atypical product quality trends while review of investigations. Lead and develop quality systems personnel and drive quality culture for the site.
• Establish, revise, review and continuously improve procedures for all Quality Systems and serve as coordinator for implementation of global policies and procedures at the site.

Stakeholder:

• Responsible for coordination with Production/R&D/QA/QC/Validation for various activities
• Lead and coordinate with stakeholders for APR activities
• Periodic review of SOP’s of QA/Production/Warehouse/QC/Validation/IT etc.

Innovation:

• Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.

KNOWLEDGE, SKILLS AND ABILITIESKNOWLEDGE, 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:

• Functional – Effective communication (both written and verbally) and interpersonal skills.
• Good understanding of statistical evaluation of data
• Demonstrated “change agent” skills; inclusive of influence management, project management, vision development, and people motivation skills.
• Demonstrated ability to identify and leverage internal and external opportunities
• Good experience as project lead or similar position
• Knowledge on relevant Guidelines
• USFDA inspection exposure
• Technical – Experienced in Lab & Manufacturing Operation (Injectable), Product Development, Technology Transfer, Process Validation, Cleaning Validation and Investigations

Leadership / Managerial Attributes:

• Timely escalation to senior management
• Decision making and Accountability
• Ability to drive results with keen eye on accuracy and to work with strict deadlines
• Ability to communicate at different levels in the organizational hierarchy
• Ability to work in a dynamic team environment
• Any specialized training on investigations