Pharmaceutical Manufacturing Plant

Department: Quality

Location: India (should be ready to move to US)

Employment Type: Full-Time

Position Summary The Senior GM Quality is responsible for leading the site's Quality Assurance and Quality Control functions, ensuring all manufacturing operations comply with cGMP, FDA, and applicable state and international regulatory requirements. This role owns the quality management system (QMS) end-to-end from raw material release through finished product disposition and serves as the site's primary quality authority during regulatory inspections, client audits, and internal reviews. The ideal candidate brings deep sterile/aseptic manufacturing expertise and a track record of building or scaling quality systems in a growing pharmaceutical or compounding environment.

Key Responsibilities

• Own and continuously improve the site QMS, including deviations, CAPAs, change control, complaint handling, and product quality reviews.
• Ensure ongoing compliance with 21 CFR 210/211, USP 795/797/800 (if applicable), EU GMP Annex 1, and other relevant guidance for sterile and non-sterile manufacturing.
• Maintain site readiness for FDA, state Board of Pharmacy, and third-party audits at all times.
• Serve as the site's primary point of contact and subject matter expert during regulatory inspections and client/partner audits.

• Own final disposition (release/reject) of raw materials, in-process product, and finished goods.
• Oversee investigation and root-cause analysis for deviations, OOS/OOT results, and product complaints; ensure timely, effective CAPA implementation.
• Review and approve batch records, master production records, and validation documentation.

• Oversee environmental monitoring programs for cleanrooms and controlled areas, including viable/non-viable particulate monitoring.
• Own isolator and cleanroom qualification programs, including leak testing protocols and acceptance criteria (per ISO 14644-7, PDA TR-34, and EU GMP Annex 1).
• Partner with Engineering/Facilities on equipment qualification (IQ/OQ/PQ), calibration, and preventive maintenance programs.

• Build, lead, and mentor the QA/QC team, including quality engineers, QC analysts, and compliance staff.
• Establish clear performance metrics and accountability structures across the quality organization.
• Champion a site-wide culture of quality, accountability, and continuous improvement.

• Partner with Manufacturing, Regulatory Affairs, and Supply Chain to ensure quality is embedded in production planning, scale-up, and new product introduction.
• Support due diligence, licensing, and audit readiness activities related to business growth (new product lines, new facilities, or M&A).
• Report quality metrics, trends, and risk assessments to executive leadership on a regular cadence.

Required

• Bachelor's degree in pharmacy, Chemistry, Microbiology, Pharmaceutical Sciences, Engineering, or related field.
• 20+ years of progressive quality leadership experience in pharmaceutical manufacturing, sterile compounding, or biologics/injectables, including 5+ years in a senior leadership role.
• Demonstrated experience leading FDA and other regulatory inspections with successful outcomes.
• Strong working knowledge of cGMP, USP 795/797/800, and aseptic processing standards.
• Proven experience with deviation management, CAPA, change control, and validation (cleaning, process, equipment).
• Excellent written and verbal communication skills, with the ability to represent the company confidently to regulators, auditors, and executive stakeholders.

• Advanced degree, or relevant certification.
• Direct experience with sterile injectables
• Experience scaling a quality organization in a high-growth or newly licensed facility.
• Experience supporting new product line launches or facility expansions.