Overview

This position will be required to interact with all departments within the company and to proactively support GMP compliance. The role provides an opportunity to enhance quality skills and experience within a GMP environment.

This position is based in our Framingham location and typically has a 5-day on-site expectation.

Responsibilities

Key responsibilities:

• Work cross functionally with Quality Assurance, Quality Control, Regulatory and Clinical groups to ensure inspection readiness. Provide QA input and approvals to assist in and drive projects as needed.
• Perform batch release for GMP lots, including final Quality Review of associated quality records. Prioritize batch release in support of business needs including maintaining batch release status and communicate release needs throughout the organization.
• Drive improvement of Replimune GMP compliance and Quality systems: change control, deviation, and corrective and preventive action (CAPA) systems including support of thorough root cause analysis investigations related to quality issues.
• Possess strong writing skills to utilize best practices in documenting deviations in records and associated reports.
• Collect and report quality metrics supporting Quality Management Review (QMR) deliverables.
• Review and approve Laboratory Investigations, Out of Specification Results, Environmental Monitoring excursions and QC trending data.
• Review and approve Standard Operating Procedures (SOPs), Validation Protocols / Reports, Production Records, or GMP records, Testing Records and Engineering Drawings, ensuring internal and external standards are met.
• Interface and provide support to internal customers.
• Lead and participate in Risk assessments.
• Conduct trainings as needed (change control, batch release, risk assessment methodology, etc.).

Other responsibilities

• Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to standard operating procedures, validation documents, material specifications, etc.
• Apply six sigma or similar quality process improvement methodologies

Qualifications

Educational requirements:

• A minimum of a BA or BS degree in a Science or Logistics field or equivalent.

Experience and skill requirement:

• 6-8 years of quality experience in biopharmaceutical industry.
• Proven implementation of six sigma or other quality process improvement methods
• Strong written and verbal communication skills.
• Adaptable, flexible, and able to manage change.
• Ability to work independently on projects within a team-oriented environment.
• History of decision making leading towards continuous improvement

Location: 

• This position is based in our Framingham location and typically has a 5-day on-site expectation.