GENERAL SUMMARY:

The Quality Manager is a technical resource in the principles and application of quality assurance operations and compliance. The Quality Manager coordinates or executes activities on a wide range of projects and takes a role in the design and execution of new projects.
This is on-site job at the Leiden Center

KNOWLEDGE AND SKILLS:

• Good understanding of both the conceptual and practical application of cGMPs in a pharmaceutical setting
• Proven experience leading a variety of straightforward projects/teams within stated objectives and timelines.
• Ability to communicate effectively with cross functional team members, exchanging complex information and influencing/guiding others to understand a stated viewpoint
• Ability manage own workload to achieve goals and seek opportunities to share information and help others understand technical processes
• Formal project management experience
• Strong communication skills (written and verbal) with the ability to communicate to a variety of audiences.
• Able to integrates activities with other groups, departments and project teams as needed.
• Demonstrated ability to evaluate quality matters and solve problems leveraging technical experience and advanced judgement to select appropriate solutions
• Excellent team player and collaborator
• Experience with electronic document management systems (e.g., QDoccs, Trackwise, Veeva)

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in scientific or allied health field (or equivalent degree)
• Typically requires 4 years of experience, or the equivalent combination of education and experience
  

  onsite

• Collaborate with internal and external business partners to resolve quality issues to ensure compliant solutions.
• Lead the Working cell banks, intermediate and drug product dispositions activities.
• Perform change control assessments for the disposition and review batch manufacturing documents.
• Establish and revise the appropriate SOP’s with quality assurance operations.
• Collect data and report on metrics associated with right first batch record review.
• Represent Vertex Quality on cross functional working teams, applying strong communication and collaboration skills.
• Lead continuous improvement projects in functional department
• Author SOP’s to support commercial quality functions as needed
• Assist with regulatory agency inspections as needed.
• Identify and facilitate continuous improvement efforts