Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)
Boston, Massachusetts, United States · Hybrid
$148k–$222k/yr
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Job Description Position Summary The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene…
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$148k–$222k/yr
Full-time
bachelor degree
Annual Bonus, Annual Equity Awards, Medical Insurance, Dental Insurance, Vision Insurance, Paid Time Off
Posted 28d ago
~40 hrs/week
Responsibilities
The Associate Director oversees the strategic design and tactical execution of quality systems, risk management, and quality culture for Cell and Gene Therapies. Key duties include leading the Annual Product Quality Review (APQR) and managing the Data Integrity program.
Requirements
Requires a Bachelor's degree in a scientific or business discipline and over 10 years of experience in product life cycle development. Candidates must possess deep expertise in global GMP regulations and strong leadership skills in a matrix environment.
Full job description
Job Description
Position Summary
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 CGT. Identifyand 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
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 [email protected]
Related keywords
Cell and Gene TherapyVCGTGxPGMPQMSAPQRQPQAData IntegrityCAPAQuality Risk ManagementBiotechnologyRoot Cause AnalysisComplianceInternal AuditExternal AuditProduct Life Cycle
Together we deliver connected solutions to conquer tax complexity.
Industry
Software Development
Company size
1,001-5,000 employees
Headquarters
King of Prussia, PA
LinkedIn followers
68,987
Total funding
$345M
The rapid changes taking place in today’s global business, technology, and regulatory environments are having a compounding effect on the complexity of indirect tax management and putting more pressure on the corporate tax function than ever before. This complexity demands intelligent solutions that enable businesses to satisfy tax obligations and support growth opportunities.
The Trusted Leader in Tax Technology
We're Vertex (VERX). A pioneer in tax automation for more than 40 years. We proudly serve over 4,000 customers worldwide with distinction and provide comprehensive tax solutions that enable global businesses to transact, comply and grow with confidence.
Our software, content and services address the increasing complexities of global commerce and compliance by reducing friction, enhancing transparency and enabling greater confidence in meeting indirect tax obligations. As a result, our software is ubiquitous within our customers’ business systems, touching nearly every line item of every transaction that an enterprise can conduct. Our software is fueled by over 300 million data-driven effective tax rules and supports indirect tax compliance in more than 19,000 jurisdictions worldwide.
We partner with the world’s most respected companies and harness their strengths to deliver the best tax technology solution to businesses across the globe. We integrate with key technology partners that span ERP, CRM, procurement, billing, POS and e-commerce platforms. We also work closely with over 50 tax, accounting and consulting firms to provide the integrated tax technology solutions.
Our culture is the foundation of everything we do, guided by a common purpose to build trusted relationships at work, in business and in our communities. We strive to be a values-driven employer of choice who attracts, retains and inspires talented professionals to achieve their full potential. We employ over 1,100 full-time professionals today in the US, Europe and Brazil.
Offices: 2301 Renaissance Blvd, King of Prussia, PA 19406, US · 40 Shuman Blvd., Suite 218, Naperville, IL 60540, US · 1 Furzeground Way, Stockley Park, Stockley Park, Uxbridge UB11 1EZ, GB · 101 Arthur Andersen Parkway, Suite 300, Sarasota, FL 34232, US · Gustav Mahlerplein, Amsterdam, North Holland 1082, NL
taxtransaction taxindirect taxtax compliancesoftwareVATvalue added taxsales and usemanaged servicesreturns outsourcing
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