Sr. Quality Manager

Stark Pharma Solutions Inc; Longview (WA); On-site; USD 120,000 - 150,000; Full time

Job summary

Stark Pharma Solutions Inc. is seeking a Sr. Quality Manager in Washington to oversee QA activities for drug substances, products, and devices.

You will ensure cGMP compliance, manage investigations, CAPA, change controls, and supplier quality programs while partnering with CMOs and cross-functional teams. The role requires 8+ years in QA, extensive GMP experience, and strong leadership to drive risk-based quality improvements in a fast-paced environment.

Qualifications

• Bachelor's degree in a scientific or life sciences field.
• 8+ years in Quality Assurance/Quality Systems within a regulated pharma setting.
• Deep knowledge of cGMP and global GMP requirements for biologics/pharma.
• Experience supporting GMP drug product manufacturing and disposition.
• Proven leadership in quality investigations, deviations, OOS, RCA, and CAPA.
• Experience with change controls and Quality Agreements.
• Proficient with electronic QA documents (QDocs/TrackWise/Veeva).
• Strong leadership and ability to drive cross-functional collaboration.

Responsibilities

• Collaborate with partners to resolve complex quality issues and implement compliant solutions.
• Serve as a senior QA technical resource on cross-functional teams.
• Draft, review, and maintain Quality Agreements with CMOs and suppliers.
• Initiate, assess, and document change controls per procedures.
• Lead quality investigations, deviations, OOS, RCA, and CAPA activities.
• Review and approve batch records for drug substances, products, and finishes.
• Provide QA guidance to address compliance gaps and enhance systems.
• Support GMP document reviews and risk mitigation across programs.
• Identify quality risks and drive appropriate remediation strategies.
• Support internal and external audits and continuous improvement.

Skills

Quality leadership

cGMP knowledge

CAPA investigations

Change controls

GMP batch review

CMO oversight

Risk management

Document management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in life sciences

Tools

QDocs

TrackWise

Veeva

Job description

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.

Position :

Sr. Quality Manager

Location : Washington

Duration : Long Term

Job Overview

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.

Key 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.

Required Qualifications

• 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.

Stark Pharma is an Equal Opportunity Employer and welcomes qualified candidates from diverse backgrounds.