Sr. Quality Manager

Stark Pharma Solutions Inc. is a global consulting and staffing partner established in 2014, serving the Pharmaceutical, Medical Device, Biotech, and IT industries across the USA, Canada, and India. We provide specialized consulting and staffing solutions across Quality & Validation, Regulatory Affairs, R&D, Manufacturing, Supply Chain, Project Management, and IT, with a focus on delivering tailored solutions that drive growth, operational excellence, and long-term client success.

About the role

We are seeking a Sr. Quality Manager with strong experience in Quality Assurance, cGMP compliance, and pharmaceutical/biologics manufacturing to support complex projects involving drug products and devices. The role will serve as an advanced technical Quality resource, providing QA oversight for GMP disposition, investigations, CAPA, change controls, batch record review, supplier/CMO activities, and quality systems.

Responsibilities

• Collaborate with internal and external business partners to resolve complex quality issues and develop compliant solutions.
• Serve as an experienced Quality technical resource on cross-functional teams.
• Draft, review, and maintain Quality Agreements with CMOs and suppliers as required.
• Initiate and assess change controls and ensure compliance with established procedures.
• Conduct quality investigations, deviations, and OOS assessments, including Root Cause Analysis (RCA) and product impact assessments.
• Review and approve CAPA actions for adequacy, effectiveness, and compliance.
• Review and approve master and executed batch records supporting drug substance, drug product, and finished goods disposition.
• Provide recommendations to address compliance gaps and enhance quality systems.
• Conduct GMP document reviews, including procedures, work instructions, specifications, methods, protocols, and method reports.
• Identify and communicate quality risks and support appropriate risk mitigation strategies.
• Support internal and external audit activities.
• Provide independent QA guidance for complex, multifaceted projects.
• Collaborate with cross-functional teams to drive continuous improvement and maintain GMP compliance.

Requirements

• Bachelor’s degree in a scientific, life sciences, allied health, or related field.
• 8+ years of experience in Quality Assurance, Quality Systems, or a related regulated pharmaceutical environment.
• In-depth knowledge of cGMP principles and global GMP requirements in biologics and pharmaceutical manufacturing.
• Strong experience supporting GMP drug product manufacturing and disposition activities.
• Extensive experience working with Contract Manufacturing Organizations (CMOs) and suppliers.
• Strong experience leading quality investigations, deviations, OOS assessments, RCA, and CAPA.
• Hands-on experience with change controls, Quality Agreements, batch record review, and product impact assessments.
• Strong understanding of quality risk management and risk mitigation practices.
• Experience with electronic document management and quality systems such as QDocs, TrackWise, or Veeva.
• Demonstrated ability to manage complex projects in a fast-paced, cross-functional environment.
• Strong leadership, communication, organizational, and decision-making skills.
• Ability to independently evaluate complex quality matters and provide effective QA recommendations.