Job Description
Job DescriptionnGeneral/Position Summaryn
TheDirector,QualityAssurance GMP Operationsis responsible for theapplicableCell & GeneCDMOand is responsible for theend to endquality oversight of allproductand activitiesat the CDMO. Responsibilities includeday-to day operationalquality oversightincluding assuring progressionofbatch recordoperations,resolution andon time dispositionof product,quality continuous improvements,changes associated with the process and associated implementation, trends, and overall quality performance of the CDMOs.
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The role will closely partner with operational stakeholders to lead/support the development and execution of quality & technical riskmitigation, execution of operational activitiesandparticipationingovernance committees. A key expectation is the ability to closely collaborate and build relationships withinternaland externalstakeholderstodrive compliance and continuous improvement activities. The role may also be required to support on site manufacturing activitiesat the CDMO.
nKey Duties & Responsibilitiesn
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- Establishment of quality oversight for external CTO/CDMO operationsincluding assurance of on time ofbatch disposition process,across development, launch and commercialmanufacturing globally.
- Lead, Develop, and implementcontinuousqualityimprovements to advance quality outcomes and operational excellence in processes.
- ProactivelydevelopCompliance metrics as key indicatorsand takes action to mitigate.
- Maintain full oversight ofCDMO QMSincluding driving deviationreductionand assuring timely resolution of CAPAs.
- Act as the SME for the CDMO,understandingscope of all changes, driving applicable global change control implementation with the external manufacturing partner to meet global product goals.
- Represent Quality and serve as a trustedpartner for the dispositionactivities of drug product.
- Build strategic relationshipsand foster a culture of collaborationwith internal and external partners – CDMOs and CTOs within the Quality organizationto ensure Quality issues are raised and addressed, as necessary.
- Lead/support the development of quality & technical riskmitigationthrough identification and mitigation compliance gaps.
- Lead and mentor other team members, support development of organizational capabilities and talent building.
- Act as the batch disposition subject matter expert (SME) in support of regulatory inspections and audits.
- Establish/participateand lead GxP Cell & Gene Therapy Management Reviews to gain insights regarding efficiency and operational performance across the GXP operations, including identification of opportunities for improvement and associated actions.
- Work closely with the cross- functional partners to prepare for and support Health Authority inspections, respond to information requests, adjudicate compliance discussions, and negotiate any required corrective actions.
- Represent C&G Quality to lead/participate in complex projects and partner with key stakeholders for alignment in strategic and operational planning and delivery of business & financial priorities and goals.
- May be required to support manufacturing on site activities.
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nRequired Education Leveln
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- Batchelor’s degree or relevant comparable background.
- Masters preferred.
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nRequired Experiencen
10+ years of experience and 5+ years in a management/supervisory role, or the equivalent combination of education and experience in a regulated pharmaceutical environment
nRequired Knowledge/Skillsn
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- In-depth global health regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics(EU GMPs, FDA 21CFR Part 1271,GxPs).
- Broad and current knowledge ofbatch disposition industry trends and best practices in Cell/Gene therapies.
- Preferred QA Operational experience for Autologous Cell Therapy Operations.
- Broad technical knowledge in Cell technology, aseptic manufacturing technology, analytical assays, cell & genetic therapies/Biologics processing, fill/finish and testing.
- Demonstrated strategic planning and execution skills required for operational effectiveness and compliance.Provenability with Root Cause Analysis, data analytics, and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma.
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence.
- Ability to apply risk management principles to decision making and operational priorities.
- Critical Thinking and Problem Solving skills
- Ability to closely collaborate and build relationships withinternal and external stakeholders.
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nOther Requirementsn
Indicate required certifications, licenses or specialized trainings.
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Up to 25% Travel may be required
nFlex Designation:n
Hybrid-Eligible Or On-Site Eligible
nFlex Eligibility Status:n
In this Hybrid-Eligible role, you can choose to be designated as:
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1. Hybrid : work remotely up to two days per week; or select
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2. On-Site : work five days per week on-site with ad hoc flexibility.
nCompany Informationn
Vertex is a global biotechnology company that invests in scientific innovation.
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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.
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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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