Vertex Pharmaceuticals
Director QA Operations, Cell& Gene, Mfg Systems
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job DescriptionDirector 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.
Flex DesignationHybrid-Eligible Or On-Site Eligible
Flex Eligibility StatusIn this Hybrid-Eligible role, you can choose to be designated as:1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company InformationVertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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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.
Flex DesignationHybrid-Eligible Or On-Site Eligible
Flex Eligibility StatusIn this Hybrid-Eligible role, you can choose to be designated as:1. Hybrid: work remotely up to two days per week; or select2. On-Site: work five days per week on-site with ad hoc flexibility.
Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.
Company InformationVertex is a global biotechnology company that invests in scientific innovation.
Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com.
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