Director QA Operations, Cell& Gene, Mfg Systems
5 days ago
Job Description
Director of Quality Cell & Gene, Manufacturing Systems is accountable for ensuring Operational Systems related improvements and projects are planned, prioritized, and executed in a systematic manner. The role is accountable for leading/supporting continuous improvements of quality operations processes, development of digital roadmaps including Quality user requirements, details of Quality process flows and assuring realization of such requirements into systems and procedures.
The role provides Quality oversight to assure that the Quality requirements are appropriately built in and executed within the key Vertex initiatives such as commercial launches, technology projects and efficiency driving measures.
The role will be highly cross-functional and will require meticulous planning, resources allocation and effective partnering with quality and other stakeholders - MSAT, DTE, QC - to participate in Cell and Gene therapies program oversight and associated governance.
Key Duties & Responsibilities
- Lead the development and implementation of continuous improvement quality operations activities and processes.
- Ensure Quality Operations processes are in compliance with regulations. Proactively identify gaps and mitigate risks.
- Lead/Participate in development the strategy for project and represent as the quality expert in governance forums to ensure Quality requirements are appropriately included and prioritized for implementation.
- Proactively recognize and work with others to resolve risks to the timeliness or quality of the deliverables, escalating appropriately.
- Establish / evolve project team, identify opportunities for efficiencies, and demonstrate agility negotiating and shifting priorities, course correct where needed to ensure successful outcomes.
- Develop effective organization structure to efficiently support ongoing Quality Operations continuous improvements/projects and other operational activities, build out dashboards to report progress and at-risk areas.
- Anticipate Quality and regulatory needs and adjust QA input to efficiently and effectively drive/support deliverables.
- Leverage technical expertise and experiences across QA to resolve critical challenges; ensure effective communication and escalation where needed.
- Align resources and priorities across Quality functions to successfully lead/partner on effective change management efforts, and oversee development of cut-over plans where needed.
- Champion changes, establish/influence a change-agile work environment and lead the team effectively.
Knowledge and Skills:
- Broad technical experience in Cell and Gene Therapy technology clinical to commercial life cycle management, and manufacture science and technology.
- In depth knowledge of EU and FDA regulations covering Cell & Gene GMP/GDP manufacturing operations and distribution.
- Effective business analytical skills to allow for critical analysis of the processes and practices.
- Ability to chair governance meetings, and establish dashboards, reporting.
- Solid project management skills, ability to work on advanced reporting industry standard solutions such as Smartsheet, PowerBI.
- Experience with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
- Excellent communication skills; proven track record.
- Influencing/building/promoting a culture of Quality Excellence.
- Strong leadership, ability to work in a matrix environment and an innate ability to collaborate and build relationships.
Education and Experience:
- Bachelor's degree in an engineering/Lifesciences field and/or Master's degree in business analytics/management/industrial engineering.
- Typically requires 10+ years of relevant industry experience such as manufacturing, quality assurance, and/or quality control in biotechnology/regulated pharmaceutical environment.
- A minimum of 5 years leadership experience leading teams or matrix management of projects.
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