Sr. Manager, GMP Quality

Duration: 6 Months (Contract)
Work Schedule: 40 hours per week
Location: Remote
Pay Rate:$100-$104 on W2 /hr.

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.

• Serve as the Quality Assurance (QA) representative on cross-functional project teams collaborating with internal departments including Quality Supply Chain CClient 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 CClient 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.

• 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

Absolutely heres a clean polished and presentation-ready job description with all references to Sumitomo/SMPA removed and wording tightened for clarity and professionalism.

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

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.

• Serve as the Quality Assurance representative on cross-functional project teams collaborating with internal Quality Supply Chain CClient 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 CClient 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.

• 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.

• Bachelors 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.