Sr. Quality Manager

About the Company

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.

Sr. Quality Manager

Role:
Seeking a Sr. Quality Manager to serve as an advanced technical resource in quality assurance and compliance, coordinating and executing activities across multiple complex projects with an emphasis on QA GMP disposition of drug products and devices.

Key Responsibilities:

• Collaborate with internal and external partners to resolve complex quality issues and ensure compliant solutions.
• Participate in cross-functional teams as an experienced Quality technical resource.
• Draft and enforce Quality Agreements between CMOs/Suppliers and the client.
• Support Change Control owners with compliance to change procedure requirements; initiate and assess change controls.
• Conduct quality investigations/deviations, including root cause analysis and product impact assessments for deviations and OOS.
• Review CAPA plans for adequacy and compliance; approve investigations/CAPAs.
• Review and approve master and executed batch records supporting DS, DP, and FG disposition activities.
• Recommend tactics and enhancements to address compliance gaps within cross-functional quality systems.
• Conduct GMP document review - procedures, work instructions, specifications, methods, protocols, and method reports.
• Identify and communicate risks; assist with risk mitigation plans.
• Support internal and external audit programs.

Required:

• Bachelor's degree in a scientific or allied health field (or equivalent).
• Typically 8+ years of relevant experience (or equivalent combination of education/experience).
• In-depth knowledge of cGMPs in a biologics + devices pharmaceutical setting, including global GMP Drug Product manufacturing requirements.
• Strong experience managing complex CMO projects and driving continuous improvement.
• Strong experience with quality risk management, identifying and mitigating risks.
• Strong experience leading event investigations, RCA, and CAPA.
• Strong experience with electronic document management systems (QDocs, TrackWise, Veeva).
• Demonstrated ability to work independently on large, multifaceted QA initiatives.
• Strong cross-functional communication skills, with the ability to influence and align stakeholders.