Contract Manager Jobs

About The Position

Requirements

• Bachelor’s degree in biotechnology, life sciences, engineering, or a related field.
• At least 5 years of relevant industry experience, such as manufacturing, Quality Assurance, and/or Quality Control in a biotechnology or regulated pharmaceutical environment.
• Progressive relevant experience in a regulated biotechnology or pharmaceutical environment, with experience in Quality Assurance, Quality Control, manufacturing operations, or analytical development.
• Experience supporting analytical method lifecycle activities, quality events, laboratory systems, and quality-system processes.
• Strong knowledge of global GxP regulatory expectations for Cell and Gene Therapy and/or biologics, including ICH, FDA, and EU requirements.
• Working knowledge of analytical development, method qualification, validation, verification, transfer, and stability activities.
• Knowledge of cGMP quality systems, including deviations, OOS investigations, CAPA, change control, risk management, and inspection readiness.
• Ability to apply risk-based thinking, critical thinking, and problem-solving to quality decisions and operational priorities.
• Demonstrated ability to lead quality-improvement projects using tools such as root-cause analysis, data analytics, Lean, DMAIC, or Six Sigma.
• Strong written and verbal communication skills, including technical review and quality-event documentation.
• Ability to influence, collaborate, and build alignment across cross-functional teams in a matrix environment.
• Ability to work on-site five days per week; the role may require minimal travel to support technology transfer.

Nice To Haves

• Master’s degree or comparable relevant background.
• Expertise in Quality Control, including experience with flow cytometry assays, cell-based assays, method validation, technology transfer, and analytical investigations.

Responsibilities

• Provide proactive, hands-on QA oversight of analytical development and QC laboratory activities, including method qualification, transfer, verification, and validation.
• Review and approve analytical lifecycle documentation, including protocols, reports, assay packets, LIMS master data, LES data, deviations, change controls, risk assessments, and investigation reports.
• Lead and support investigation, assessment, trending, and timely closure of QC-related quality events, including out-of-specification investigations.
• Ensure appropriate data verification and compliance review for deviations, root-cause analyses, CAPA activities, and change controls.
• Maintain QA oversight of stability-program activities to ensure compliance with Vertex procedures, cGMPs, and EU and US regulatory standards.
• Identify compliance risks, quality-system gaps, and continuous-improvement opportunities, and partner with stakeholders to implement mitigating controls and actions.
• Support development, implementation, and maintenance of analytical quality standards, procedures, training materials, and best practices.
• Participate in cross-functional Cell and Genetic Therapy projects and governance forums, providing quality input, assessing proposed changes, and promoting standardized compliant processes.
• Support preparation and review of relevant regulatory-submission sections and responses to regulatory questions, as assigned.
• Support health-authority inspection and information-request readiness, including documentation preparation and follow-up actions.
• Support contract testing laboratory management, including development and review of Quality Agreements.
• Lead or participate in quality and technical improvement projects using root-cause analysis, data analytics, and operational-excellence approaches.
• Coach, guide, and mentor QA team members and cross-functional partners to help build a culture of Quality and Excellence.