The Quality Systems Associate Director supports strategicdesignofand ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization.The roleis responsible forpartnering with cross-functional technical development and commercial teams to align andfacilitateharmonization of strategy, procedures and processes related to the Quality Management System and to drive Quality improvements.
This position reports directly to the Director of Quality.
Key Duties & Responsibilities
The responsibilities of this position may include, but are not limited to, the following:
-Process Lead for Annual Product Quality Review (APQR) and Quarterly Product Quality Assessment (QPQA) including:
Responsible for leading and providing functional process oversight for APQR and QPQA
Ensure all APQR and QPQA are executed on time andin accordance withprocedures and regulatory requirements
Monitor and support the quality riskmanagementprogram items associated with CGTIdentifyand implement continuous improvement projects to improve processes and make them efficient and scalable
-Process Lead for VCGT Data Integrity (DI) program
Define DI complianceoperationalstrategiesto bedeployedat the local site levelandmonitoredfor effectiveness, including governance
Collaborate with Global Process owner toidentifyand implement DI continuous improvement projects to mature processes and make them efficient and scalable
Responsible for local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management
Leads the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans
Collaborates with internal and external business partners to resolve complex quality issues to ensure compliant solutions
Provide hands-onexpertisein theday-to-daymanagement of data collection systems and control within theGxPQuality Management System using digital solutions
Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes
Supports internal audit or external audit programs
Works to enhance Quality Culture across VCGT organization
Provides Project Management leadership for department projects/initiatives.
Required Education Level
Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field
Required Experience
Requires 10+years of experience or the equivalent combination of education and experience
Experience in product life cycle from discovery to commercial product development
Required Knowledge/Skills
Broad and deepexpertisein global GMP regulations,guidances, and Quality Management Systems, as well as a strong understanding of industry standards and best practices across theGxPlifecycle
Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment
Ability to assess impact across multiple procedures and systems
Ability to lead and manage complex projects/teams within corporateobjectivesand project timelines
Proficiencyutilizingproject management processes / tools to lead meetings,assistwith project planning andfacilitatecompletion of tasks
Excellent technical writing,presentationand communication skills
Ability to effectively influence others within technical area of expertise
Outstanding facilitation,communication, andcoaching/influencing skills
Provenability to lead improvement projects and project teams
Ability to navigate through ambiguity and rapid growth and adapt to change
Proven ability toidentifyand analyze performance indicators.
Extensive experience conducting investigations, performing root causeanalysisandidentifyingCAPA
Other Requirements
Up to 15% travel
Pay Range:
$148,000 - $222,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.
At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex 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 select
2. 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.
#LI-Hybrid
Company Information
Vertex 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
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and have made significant advancements in multiple chronic, life-shortening genetic diseases — cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia — and continue to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency.
Our global HQ is in Boston, and we have research and development (R&D) sites and commercial offices worldwide.
Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards.
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