Glenmark Pharmaceuticals · 21 hours ago
Quality Specialist, Vendor Management
Elmwood Park, NJ
Full-time
Onsite
Mid, Senior Level
$75K/yr - $85K/yr
5+ years expGlenmark Pharmaceuticals is a global leader in the development and commercialization of generic drugs. The Quality Specialist is responsible for managing vendor activities, conducting audits, and ensuring compliance with quality agreements to support the company's operations and new product launches.
BiotechnologyHealthcarePharmaceuticalHealth Care
Responsibilities
Ensure and coordinate that CMO/Vendor audits are carried out per audit schedule
Perform vendor audits of existing and new CMO/CPO/CTL/Vendors (Contract Manufacturing Organization/ Contract Packaging Organization/ Contract Testing Laboratory/ Raw & Packaging Material Vendors)
Preparing/Review of audit agenda, audit reports and carry out follow-ups regarding audit report response from CMO/Vendors and ensure adequate implementation of proposed CAPAs by CMO/Vendors
Maintaining the trackers for CMO/CPO/CTL/Vendor Audits and updating the record in SAP
Preparing, revising and maintaining Quality Agreements with CMO and Vendors
Ensure that Quality Agreements are being followed
Handling of Quality Activities in SAP
Review of APQR and keeping track of all proposed activity in APQR for implementation and coordinate with CMOs for any specific trend/observations observed during review
Review of stability data and keeping track of completion of stability study as per the stability schedule/protocol
Handling of Quality Management system associated with CMOs / Third Party Vendor Products
Provide support for new launch activities
Scheduling periodic calls with CMOs/IL partners
Generate the score card for each vendor and providing the true feedback to them to strengthen the Quality system and producing good quality products
Supporting cross-departmental projects in providing quality/compliance oversight
Handle/carry out other QA related activities/projects as assigned by supervisor
Qualification
Required
Bachelor's degree in a relevant scientific discipline or equivalent work experience
Approximately 5– 7 years in a similar role, with experience of working in a pharmaceutical or biotech company
Fluent in English
A professional approach at all times
Excellent presentation, written and verbal communication skills, capable of interfacing with all levels in the company and stakeholders and with internal and external customers
An engaging, assertive nature with excellent inter-personal skills
A motivated self-starter, self-reliant and a strong, co-operative proactive team player capable of working in global teams, with strong influencing and negotiating capability, persistence and a strong determination
Knowledge of CFR
SAP or any other ERP system
Preferred
Experience of having Sterile operations is preferred
Benefits
Paid time off
401k plus company match
Company paid health benefits
Dental
Vision
Onsite access to company gym
Paid Employee Referral Program
EAP – Employee Assistance Program
Accident Insurance
Critical Illness Insurance
Short-Term Disability
Life and AD & D Insurance
Whole Life Insurance
Pet Insurance and so much more!
Company
Glenmark Pharmaceuticals
Glenmark Pharmaceuticals Ltd. (GPL) is a research-driven, global, integrated pharmaceutical company.
10001+ employees
H1B Sponsorship
Glenmark Pharmaceuticals has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (9)
2024 (4)
2023 (1)
2022 (4)
2021 (6)
Funding
Current Stage
Public CompanyTotal Funding
$58MKey Investors
HDFC Mutual FundTrue NorthActis
2025-06-19Post Ipo Equity
2018-08-13Post Ipo Equity
2002-07-01Private Equity· $48M
Leadership Team
Brendan O'Grady
Chief Executive Officer
Rajeev Sharma
Senior Vice President Finance & CFO - North America
Recent News
Mexico Business
2026-01-22
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2026-01-22
2025-12-24
Company data provided by crunchbase