Vertex Pharmaceuticals Incorporated
Associate Director, GDP Operational Quality (Hybrid)
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Job DescriptionGeneral Summary:The Associate Director, Quality role will work with the GDP Operational QA Management team to ensure that medicines are distributed in the US in compliance with GDP and GMP requirements. The position will manage the day to day Quality oversight of the Third Party Logistics provider and provide support for key stakeholders within Vertex.This Position Reports to: Director, GDP Operational Quality, International QAKey Duties and Responsibilities:Serve as the primary contact and have oversight of Distribution and Logistics partners within the US, including:
Preparation and maintenance of Quality AgreementsReview of deviations, CAPA and changesMaintaining KPIsAnalyze, resolve, or assist in solving compliance and customer issues.Escalation of issues
Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMSAccountable for New Product Launch activities within the US providing distribution requirements and expectations.Working collaboratively with key internal stakeholdersMaintain QMS within the Vertex Inc.Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessarySupport recalls, mock recalls and any other on-market activity.Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.Planning/Preparation/supporting/hosting for Regulatory inspectionsProviding front and backroom inspection supportPost inspection follow-up with responses and CAPAs (Continuous improvements)Manage/Approve/Assess event investigations "deviations" (including Fast Track deviations)Manage CAPAs and Effectiveness ChecksPerform other duties as per GDP guidelines and Vertex policies and procedures
Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.Ensure that customers and suppliers are approvedApproving any subcontracting activities that may impact GDP.Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.Ensure that any additional requirements imposed on certain products by national law are adhered to.
Create/review and approve Standard operating Procedures and other Quality DocumentsKnowledge and Skills
:Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.5+ years' experience serving in a Quality role.Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.Influencing skills in areas with no direct reporting authority.Strong interpersonal and communication skills.Auditing skills, appropriate qualifications in auditing an advantage.Fluency in English is requiredProficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)Education and Experience:Master's degree and 4-5 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.Hybrid-Eligible RolesIn this Hybrid-Eligible role, you can choose to be designated as:Hybrid:
work remotely up to two days per week;
or selectOn-Site
: work five days per week on-site with ad hoc flexibility.#LI-HybridFlex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In 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
#J-18808-Ljbffr
Preparation and maintenance of Quality AgreementsReview of deviations, CAPA and changesMaintaining KPIsAnalyze, resolve, or assist in solving compliance and customer issues.Escalation of issues
Remain up to date in GDP and logistics developments and emerging regulations to guide the maintenance of the QMSAccountable for New Product Launch activities within the US providing distribution requirements and expectations.Working collaboratively with key internal stakeholdersMaintain QMS within the Vertex Inc.Ensure distribution licences (where required) accurately reflect the current organisation, vary licence where necessarySupport recalls, mock recalls and any other on-market activity.Serve as QA assessor/approver on Change Controls: resolve gaps, approve change plans, classifications, strategy for GDP/GMP actions.Support the GDP Management Review process; Review and assess the risk of inputs such as metrics, regulatory intelligence, and identified risks and gaps; Recommend mitigation approaches.Participate in expansion activities to ensure that Quality related actions are planned into projects and completed in line with the commitments, e.g. QMS build out, Distribution licences (or equivalent) application, audits, and Quality Agreements.Planning/Preparation/supporting/hosting for Regulatory inspectionsProviding front and backroom inspection supportPost inspection follow-up with responses and CAPAs (Continuous improvements)Manage/Approve/Assess event investigations "deviations" (including Fast Track deviations)Manage CAPAs and Effectiveness ChecksPerform other duties as per GDP guidelines and Vertex policies and procedures
Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.Ensure that customers and suppliers are approvedApproving any subcontracting activities that may impact GDP.Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.Deciding on the final disposition of returned, rejected, recalled or counterfeit medicines, including the approval of returns to saleable stock.Ensure that any additional requirements imposed on certain products by national law are adhered to.
Create/review and approve Standard operating Procedures and other Quality DocumentsKnowledge and Skills
:Bachelor's in a scientific or allied health field and relevant GDP & GMP work experience, or relevant comparable background.5+ years' experience serving in a Quality role.Clear understanding to ensure operations do not compromise the quality of products and can demonstrate compliance with GDP.Influencing skills in areas with no direct reporting authority.Strong interpersonal and communication skills.Auditing skills, appropriate qualifications in auditing an advantage.Fluency in English is requiredProficiency in using Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint)Education and Experience:Master's degree and 4-5 years of relevant work experience, or Bachelor's degree in a scientific or allied health field (or equivalent degree) and 9+ years of relevant work experience, or relevant comparable background.Hybrid-Eligible RolesIn this Hybrid-Eligible role, you can choose to be designated as:Hybrid:
work remotely up to two days per week;
or selectOn-Site
: work five days per week on-site with ad hoc flexibility.#LI-HybridFlex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In 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
#J-18808-Ljbffr