Companies you'll love to work for

KEY RESPONSIBILITIES:

• Manage 3-4 teams (varying in size from 3-10) for deviation, CAPA, analytical investigation, risk assessment, and change control.

• Establish and run monthly quality event record escalation meetings with CMC Core Team and other cross-functional management.

• Lead cross functional investigations for deviations to determine root cause and present findings and recommendations to CMC leadership team for alignment subsequent draft and manage appropriate CAPAs.

• Establish and continually promote MTO best practices to further establish quality event record center of excellence teams.

• Facilitate risk assessments with cross-functional team including process development, manufacturing, quality control, quality assurance, regulatory.

• Maintain compliance to company policy and regulatory guidance.

• Provide continuous support to all stakeholders to ensure successful product release.

• Act as quality record subject matter expert in inspections and audits with regulatory agencies.

• Demonstrate Vertex shared behaviors: Lead by Example; Learn, Teach & Develop; Foster Exceptional Collaboration; Drive Breakthrough Results; and Promote Enterprise Thinking.

• Other duties and projects as assigned to meet departmental requirements.

MINIMUM QUALIFICATIONS:

• Bachelors degree in science or related discipline

• 10+ years progressive experience in pharmaceutical

• development and manufacturing.

• 6+ years of experience mentoring and managing staff.

• Understanding of science and technology of GMP cell and gene manufacturing environment.

• Excellent planning and organizational skills, with the ability to balance production, development and continuous improvement needs.

• Excel in interpersonal relations, showcasing ability to lead through influence and effectively lead high performing teams.

• Expert level proficiency with technical writing and data visualization.

• Excellent verbal and written communication skills.

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