Vertex Pharmaceuticals Incorporated
Senior Director, Quality Operations, Commercial Manufacturing - Cell & Gene Ther
Vertex Pharmaceuticals Incorporated, Boston, Massachusetts, us, 02298
Overview
Senior Director of Quality Operations / Site Quality Head CMC Cell & Gene Therapy provides strategic and operational leadership for all quality-related activities at the Cell & Gene Therapy manufacturing site. The role is responsible for building a phase-appropriate quality roadmap from clinical through commercialization to meet business, regulatory and operational requirements. Responsibilities include leading the quality operations team across multiple shifts to maintain product quality, improve GMP processes and assure compliant manufacturing operations. The role partners with operational stakeholders to lead and support the development and execution of quality projects, quality & technical risk management including execution of mitigation plans, and participates in Cell & Gene Therapy projects and governance committees. This is an onsite role, 5 days per week at the Leiden Center, Vertex Pharmaceuticals, Seaport, Boston. Key Duties and Responsibilities
Establish quality oversight for internal quality operations from research to commercial stage including manufacturing and distribution of product globally.
Represent Quality in Cell & Gene Therapy Programs and serve as a trusted advisor to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
Establish and lead GxP Cell & Gene Therapy Management Reviews to gain insights on efficiency and operational performance, identify opportunities for improvement and associated actions.
Support/lead risk management activities, including mitigation plans and execution.
Provide quality leadership for oversight of production controls, including internal manufacturing operations, aseptic processing, materials management and quality control.
Establish and maintain robust quality systems, including SOPs, policies, and procedures for site internal quality operations.
Maintain quality oversight of production controls to ensure compliant practices, identify opportunities for improvement and drive resolution and mitigation with business partners.
Monitor regulatory and external intelligence for best practices and trends to support Cell & Gene Therapies quality operations and programs.
Oversee site readiness for regulatory inspections, internal audits and commercial operations; prepare for Health Authority inspections and implement corrective and preventive actions.
Represent C&G Quality in complex projects and collaborate with stakeholders to align on strategic and operational planning and delivery of business and financial goals.
Create a culture of collaboration, development, and engagement to advance quality outcomes and operational excellence.
Lead and mentor team members and support development of organizational capabilities and talent.
Knowledge and Skills
In-depth global health regulatory knowledge and experience across the GXP life cycle in Cell & Gene therapy and/or Biologics.
Broad technical knowledge in Cell technology, aseptic manufacturing, analytical assays, cell & genetic therapies/biologics processing, fill/finish and testing.
Current knowledge of industry trends and best practices in Cell/Gene therapies.
Proven expertise with regulatory preparation and inspections.
Strategic planning and execution skills for operational effectiveness and compliance.
Operational Excellence experience with ability to lead improvement projects (Root Cause Analysis, data analytics; LEAN, DMAIC, Six Sigma).
Excellent communication with a track record of influencing and promoting a culture of Quality and Excellence.
Ability to apply risk management principles to decision making and priorities.
Critical thinking and problem-solving skills.
Education and Experience
Bachelor's degree in an engineering or life sciences field.
Master's degree or relevant comparable background.
Typically requires 15+ years of onsite relevant industry experience in quality assurance operations.
A minimum of 10 years of leadership experience leading teams or directing allocation of resources is preferred; previous site leadership team experience strongly preferred.
#LI-AR #LI-Onsite Pay Range:
$208,000 - $312,000 Disclosure Statement:
The range provided is based on a reasonable estimate for base salary at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary will be based on factors including skills, experience, and job-related factors permitted by law. Vertex offers total rewards including comprehensive benefits to support colleagues’ growth and wellbeing. Flex Designation:
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status:
This is a Hybrid-Eligible role; you can choose Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility). Note: Flex status is subject to Vertex policy and may change. Company Information:
Vertex is a global biotechnology company focused on scientific innovation and equal employment opportunity. Vertex is an E-Verify employer. Reasonable accommodations are provided for qualified individuals with known disabilities, as required by law. Applicants needing accommodations should contact the recruiter or Talent Acquisition at ApplicationAssistance@vrtx.com. Helping all candidates find great careers is our goal. The information you provide is secure and confidential. We encourage you to apply directly for this job on the employer’s website.
#J-18808-Ljbffr
Senior Director of Quality Operations / Site Quality Head CMC Cell & Gene Therapy provides strategic and operational leadership for all quality-related activities at the Cell & Gene Therapy manufacturing site. The role is responsible for building a phase-appropriate quality roadmap from clinical through commercialization to meet business, regulatory and operational requirements. Responsibilities include leading the quality operations team across multiple shifts to maintain product quality, improve GMP processes and assure compliant manufacturing operations. The role partners with operational stakeholders to lead and support the development and execution of quality projects, quality & technical risk management including execution of mitigation plans, and participates in Cell & Gene Therapy projects and governance committees. This is an onsite role, 5 days per week at the Leiden Center, Vertex Pharmaceuticals, Seaport, Boston. Key Duties and Responsibilities
Establish quality oversight for internal quality operations from research to commercial stage including manufacturing and distribution of product globally.
Represent Quality in Cell & Gene Therapy Programs and serve as a trusted advisor to establish the CMC quality strategy and roadmap for innovative therapeutic programs.
Establish and lead GxP Cell & Gene Therapy Management Reviews to gain insights on efficiency and operational performance, identify opportunities for improvement and associated actions.
Support/lead risk management activities, including mitigation plans and execution.
Provide quality leadership for oversight of production controls, including internal manufacturing operations, aseptic processing, materials management and quality control.
Establish and maintain robust quality systems, including SOPs, policies, and procedures for site internal quality operations.
Maintain quality oversight of production controls to ensure compliant practices, identify opportunities for improvement and drive resolution and mitigation with business partners.
Monitor regulatory and external intelligence for best practices and trends to support Cell & Gene Therapies quality operations and programs.
Oversee site readiness for regulatory inspections, internal audits and commercial operations; prepare for Health Authority inspections and implement corrective and preventive actions.
Represent C&G Quality in complex projects and collaborate with stakeholders to align on strategic and operational planning and delivery of business and financial goals.
Create a culture of collaboration, development, and engagement to advance quality outcomes and operational excellence.
Lead and mentor team members and support development of organizational capabilities and talent.
Knowledge and Skills
In-depth global health regulatory knowledge and experience across the GXP life cycle in Cell & Gene therapy and/or Biologics.
Broad technical knowledge in Cell technology, aseptic manufacturing, analytical assays, cell & genetic therapies/biologics processing, fill/finish and testing.
Current knowledge of industry trends and best practices in Cell/Gene therapies.
Proven expertise with regulatory preparation and inspections.
Strategic planning and execution skills for operational effectiveness and compliance.
Operational Excellence experience with ability to lead improvement projects (Root Cause Analysis, data analytics; LEAN, DMAIC, Six Sigma).
Excellent communication with a track record of influencing and promoting a culture of Quality and Excellence.
Ability to apply risk management principles to decision making and priorities.
Critical thinking and problem-solving skills.
Education and Experience
Bachelor's degree in an engineering or life sciences field.
Master's degree or relevant comparable background.
Typically requires 15+ years of onsite relevant industry experience in quality assurance operations.
A minimum of 10 years of leadership experience leading teams or directing allocation of resources is preferred; previous site leadership team experience strongly preferred.
#LI-AR #LI-Onsite Pay Range:
$208,000 - $312,000 Disclosure Statement:
The range provided is based on a reasonable estimate for base salary at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary will be based on factors including skills, experience, and job-related factors permitted by law. Vertex offers total rewards including comprehensive benefits to support colleagues’ growth and wellbeing. Flex Designation:
Hybrid-Eligible Or On-Site Eligible Flex Eligibility Status:
This is a Hybrid-Eligible role; you can choose Hybrid (remote up to two days/week) or On-Site (five days/week on-site with ad hoc flexibility). Note: Flex status is subject to Vertex policy and may change. Company Information:
Vertex is a global biotechnology company focused on scientific innovation and equal employment opportunity. Vertex is an E-Verify employer. Reasonable accommodations are provided for qualified individuals with known disabilities, as required by law. Applicants needing accommodations should contact the recruiter or Talent Acquisition at ApplicationAssistance@vrtx.com. Helping all candidates find great careers is our goal. The information you provide is secure and confidential. We encourage you to apply directly for this job on the employer’s website.
#J-18808-Ljbffr