Glenmark Pharmaceuticals USA
QA Director - Site Investigations & Quality systems
Glenmark Pharmaceuticals USA, Monroe, North Carolina, us, 28111
QA Director - Site Investigations & Quality systems
Get AI-powered advice on this job and more exclusive features. 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 CAPAs 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).
Financial:
JOB RESPONSIBILITIES:
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 CAPAs 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 SOPs of QA/Production/Warehouse/QC/Validation/IT etc.
Innovation:
Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
Education :
KNOWLEDGE, SKILLS AND ABILITIES:
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 Seniority level
Seniority level
Director Employment type
Employment type
Full-time Job function
Job function
Strategy/Planning and Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Glenmark Pharmaceuticals by 2x Inferred from the description for this job
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Get AI-powered advice on this job and more exclusive features. 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 CAPAs 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).
Financial:
JOB RESPONSIBILITIES:
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 CAPAs 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 SOPs of QA/Production/Warehouse/QC/Validation/IT etc.
Innovation:
Operate in compliance of cGMP, 21CFR, USP, EP and ICH regulatory requirements.
Education :
KNOWLEDGE, SKILLS AND ABILITIES:
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 Seniority level
Seniority level
Director Employment type
Employment type
Full-time Job function
Job function
Strategy/Planning and Information Technology Industries
Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Glenmark Pharmaceuticals by 2x Inferred from the description for this job
Medical insurance Vision insurance 401(k) Get notified about new Director of Investigations jobs in
Monroe, NC . Director of Security Operations Detection and Response
Charlotte, NC $145,000 - $175,000 1 week ago Charlotte, NC $130,000 - $160,000 5 days ago REGIONAL DIRECTOR, TRANSPORTATION OPERATIONS (NC)
Financial Services Associate Director | Financial Crimes, Risk and Compliance
Charlotte, NC $149,000 - $248,000 3 weeks ago Associate Director, Cloud Security Architect
Senior Compliance Director, Head of Brokerage Oversight Compliance
Director, Senior Cloud Security Architect
Associate Director, GCP Security Specialist
Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI. #J-18808-Ljbffr