Full-Time
Quality Assurance Compliance Manager
Granules
501-1,000 employees
Vertically integrated API and dosage manufacturer
Compensation Overview
$90k - $100k/yr
Chantilly, VA, USA
In Person
 Biology & Biotech (1) |
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- Expert knowledge of 21 CFR, International Council for Harmonisation (ICH), and United States Pharmacopeia (USP) regulations and standards.
- Ability to interpret and apply regulations to current good manufacturing practice operations-related queries.
- Ability to provide technical expertise in deviations, corrective and preventive actions (CAPA), root cause assessments, current good manufacturing practice compliance, and data trending.
- Ability to review and approve protocols, standard operating procedures, and investigations.
- Ability to prepare and review documentation required for regulatory submissions.
- Ability to train and develop direct reports on current technology related to current good manufacturing practice compliance.
- Lead and guide current good manufacturing practice compliance efforts at the Chantilly site in alignment with applicable regulations.
- Serve as the site Quality representative during Food and Drug Administration inspections.
- Assist with inspections by external regulators and business partners.
- Conduct compliance gap analyses and provide recommendations for gap closure, implementation, and follow-up effectiveness checks.
- Develop and execute site-wide remediation and improvement plans based on Quality metrics assessments.
- Maintain and analyze site Quality metrics to ensure continued compliance.
- Build and manage systems, processes, and cross-functional teams overseeing site compliance.
- Manage and support direct reports by establishing clear expectations and resolving conflicts.
- Ensure adherence to company procedures and promptly resolve deviations from procedures or current good manufacturing practice requirements.
- Collaborate with departments on quality issues, audits, and special projects.
- Provide manufacturing teams with guidance on Quality current good manufacturing practice issues in coordination with the Site Quality Assurance team.
- Oversee and supervise data collection for product review.
- Prepare and review documentation required for regulatory submissions as needed.
- Participate in the Quality Task Force and contribute to developing and reviewing company standard operating procedures.
- Ensure the site remains current with changes to applicable compendia, regulations, and guidance.
Granules India makes APIs, PFIs, and finished dosages, using large-scale, vertically integrated plants that control production from base chemicals to final medicines. Its products include common off-patent APIs like Paracetamol, Ibuprofen, Metformin, and Guaifenesin, and it is expanding into more complex areas such as MUPS, oncology, and peptide therapies with US FDA approvals. The company differentiates itself through full vertical integration, large scale, and a global manufacturing footprint that supports both contract manufacturing and its own branded products, offering supply security and cost competitiveness. Its goal is to deliver reliable, affordable medicines to customers worldwide while growing capabilities in complex therapies and pursuing sustainable practices like green chemistry.
Company Size
501-1,000
Company Stage
N/A
Total Funding
N/A
Headquarters
N/A
Founded
2014
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See people who can refer or advise you
Simplify's Take
What believers are saying
- Q3 FY26 revenue rose 22% to INR 1,388 crores, led by North America and Europe.
- July 2026 inspections at Genome Valley and Chantilly improved regulatory optionality and capacity.
- Europe grew 151% year-on-year in FY26, while peptide CDMO opened a new revenue vertical.
What critics are saying
- FDA warning letter dated February 26, 2025 threatens Gagillapur product approvals until remediation closes.
- Reuters on April 9, 2026 reported record-keeping and contamination concerns still burden management.
- Any second FDA action at Gagillapur can shut U.S. launches and damage Granules' generics franchise.
What makes Granules unique
- Granules integrates APIs, PFIs, and dosages, preserving cost control across the value chain.
- February 2025 Senn Chemicals acquisition adds peptide CDMO capabilities and European regulated-market access.
- Granules shipped in 80 countries and won 94 approvals by August 2026.
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Benefits
Flexible Work Hours