Job Details

Senior Manager, GMP Quality

Duration: 6 Months (Contract)
Work Schedule: 40 hours per week
Location: Remote
Pay Rate:$95-$100 on W2 /hr.

Role Overview

The Senior Manager, GMP Quality will serve as a key Quality Assurance representative on cross-functional teams, supporting clinical and commercial manufacturing activities. This role is responsible for ensuring GMP compliance, overseeing product release, managing external manufacturing partners, and supporting quality systems and continuous improvement initiatives.

Key Responsibilities

• Serve as the Quality Assurance (QA) representative on cross-functional project teams, collaborating with internal departments including Quality, Supply Chain, CMC, and Commercial Manufacturing.
• Act as the primary quality interface with domestic and international Contract Manufacturing Organizations (CMOs), contract laboratories, and third-party suppliers.
• Perform product release activities for clinical and commercial drug substances and drug products, including:
  
  • Review and approval of Master Batch Records (MBRs) and Executed Batch Records (EBRs)
  • Review of release and stability testing documentation
  • Final batch disposition to ensure product quality, safety, and supply continuity
• Partner with CMC and Commercial Manufacturing teams to support technical transfers and validation of new or existing processes and products at CMOs.
• Support commercial validation activities through review and approval of validation protocols and reports.
• Ensure compliance with established GMP procedures and quality standards; identify and implement continuous improvement opportunities through SOP and compliance standard updates.
• Author, review, and approve standard operating procedures and support implementation of electronic quality systems as needed.
• Lead, author, review, and/or approve quality events including:
  
  • Deviations and investigations
  • Corrective and Preventive Actions (CAPAs)
  • Change controls and complaints
  • Initiation and management of records within the company eQMS
• Serve as Person-in-the-Plant (PIP), as required.
• Author relevant sections of Annual Product Reviews (APRs) by compiling data, analyzing trends, and providing recommendations.
• Perform additional duties as assigned.

Required Skills & Experience

• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.
• Demonstrated experience managing external CMOs, contract laboratories, and third-party logistics providers.
• Proven experience reviewing and approving master and executed batch records and performing final disposition of drug products.
• Strong experience managing quality events, including investigations, CAPAs, and change controls.
• Working knowledge of formal risk management tools and quality risk assessments.
• Ability to evaluate technically complex quality issues and document findings with strong technical writing skills.
• Experience evolving GMP quality systems, policies, and procedures to ensure compliance with evolving

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Senior Manager, GMP Quality (Contract Role)

Duration: 6 Months
Location: Remote
Work Schedule: 40 hours per week

Position Summary

The Senior Manager, GMP Quality serves as a key Quality Assurance representative supporting cross-functional teams and external manufacturing partners. This role is responsible for ensuring GMP compliance, product quality, and uninterrupted supply of clinical and commercial pharmaceutical products through effective oversight of contract manufacturing organizations (CMOs), quality systems, and product release activities.

Key Responsibilities

• Serve as the Quality Assurance representative on cross-functional project teams, collaborating with internal Quality, Supply Chain, CMC, and Commercial Manufacturing teams, as well as domestic and international CMOs.
• Perform product release activities for clinical and commercial drug substances and drug products, including:
  
  • Review and approval of Master Batch Records and Executed Batch Records
  • Review of release and stability testing documentation
  • Final batch disposition in a timely manner to ensure product supply while maintaining quality and patient safety.
• Partner with CMC and Commercial Manufacturing teams to support technical transfers and validation of new or existing processes and products at domestic and international CMOs.
• Support commercial validation activities through review and approval of validation protocols and reports.
• Ensure compliance with established procedures and support continuous improvement initiatives by identifying opportunities to enhance efficiency and effectiveness of SOPs, compliance standards, and electronic quality systems.
• Author, review, and approve standard operating procedures and quality system documentation, as needed.
• Lead, author, review, and/or approve Quality Events, including deviations, investigations, CAPAs, change controls, and complaints within the electronic Quality Management System (eQMS).
• Interface directly with domestic and international suppliers to ensure timely and effective resolution of quality issues.
• Serve as Person-in-the-Plant, as required.
• Author relevant sections of Annual Product Reviews by compiling data, analyzing metrics, and making recommendations for continuous improvement.
• Perform other duties as assigned.

Required Skills and Experience

• Advanced knowledge of GMP manufacturing and/or market release of pharmaceutical dosage forms and/or combination products.
• Demonstrated experience managing external CMOs, contract laboratories, and third-party logistics providers.
• Proven experience reviewing and approving master and executed batch records and performing final disposition of drug products.
• Strong experience managing quality events, including investigations, CAPA, and change control, with working knowledge of formal risk management tools and assessments.
• Ability to assess technically complex quality issues and document investigations with strong technical writing skills.
• Experience evolving GMP quality systems, policies, and procedures to ensure regulatory compliance while improving workflow efficiency.
• Strong analytical skills with the ability to develop practical and effective solutions to complex quality challenges.
• Excellent verbal and written communication skills, with the ability to engage effectively with senior management, external partners, and cross-functional teams.
• Self-motivated, adaptable, and able to manage multiple priorities in a fast-paced environment while maintaining high standards of quality and compliance.

Education and Qualifications

• Bachelor's degree in a scientific discipline (e.g., Biology, Chemistry, Engineering, Pharmacy) or a related field.
• Minimum of 8 years of relevant experience in the biotech or pharmaceutical industry, with the majority of experience in a Quality role.