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LeadStack Inc.

GMP QA Validation Specialist

Durham, NC · On-site

$45 - $53/hr

Research Triangle Park, NC - 27709 Duration: 10 Months Pay Rate: $45/hr - $53/hr on W2 The Validations Contractor - GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance ...

LeadStack Inc.

GMP QA Validation Specialist

Durham, NC · On-site

$45 - $53/hr

Research Triangle Park, NC - 27709 Duration: 10 Months Pay Rate: $45/hr - $53/hr on W2 The Validations Contractor - GMP Quality Assurance, reporting to the Associate Director, GMP Quality Assurance ...

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Associate Director, GMP Quality CGT Personalized Medicine

Boston, MA • On-site

Vertex Pharmaceuticals
Biotechnology Research and Development • 1 - 5K employees
Learn more about Vertex Pharmaceuticalsexternal

Full-time

Medical, Dental, Vision, Retirement, PTO

Re-posted 3 days ago

Vertex Pharmaceuticals rating

6.5

Company rating: 6.5 out of 10

Based on 5 frontline employees who took The Breakroom Quiz

Job description

Job Description
Position Summary
The Associate Director, GMP Quality, CGT Personalized Medicine supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization. The role is responsible for partnering with cross-functional technical development and commercial teams to align and facilitate harmonization of strategy, procedures and processes related to the CGT specific processes within the global Quality Management System and to drive Quality improvements.
This position reports directly to the Director of Quality, CGT.
Key Duties & Responsibilities
The responsibilities of this position may include, but are not limited to, the following:
Quality Systems for Personalized Medicine
  • Partner with business and Quality system owners and digital stakeholders to provide and ensure Quality personalized medicine /advanced therapies CGT user requirements are embedded in lifecycle management projects from design through implementation and sustainment.
  • Establish compliance governance routines to proactively monitor compliance trends, operational performance, operational readiness, and emerging risks that may impact product quality, patient safety, supply continuity, or program execution
  • Collaborate with internal and external business partners to resolve complex quality issues to ensure compliant solutions
  • Lead the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans

Process Lead for VCGT Change Management operations for Life Cycle Management
  • Drive the VCGT process execution and problem-solving exercises with cross-functional stakeholders to address process constraints and challenges.
  • Partner with Life Cycle Management QA and cross-functional stakeholder, Manufacturing Science and Technology, Disease Area Lead to enable delivery of strategic change plans by leveraging quality expertise, system knowledge and effective communication.
  • Execute end-to-end process improvement across clinical, launch, and commercial lifecycle stages in support of personalized medicine/advanced CGT programs, enhancing decision making practices, operational tools, governance and escalation
  • Provide feedback and support to Quality System Owner to identify and implement enhancements to support the VCGT process and overall where applicable system improvements.

Process Lead for VCGT Data Integrity (DI) program
  • Collaborate with Global Process Owner and Operational Stakeholders to define and deploy DI compliance operational strategy at the local site level, including participating in the applicable governance, risk mitigation and reporting outcomes to Senior Leadership.
  • Apply expertise of Standards and Guidances to assess and guide day-to-day operations with the management of data and investigations into causes of Data Integrity failures.

Compliance & Continuous Improvement
  • Oversee CGT Quality Systems responsibilities to improve compliance visibility, efficiency, data integrity, process robustness, maturity, and scalability across quality events, change management, risk management, CAPA, and management review.
  • Work to enhance Quality Culture across VCGT organization and lead continuous quality improvement initiatives and process enhancements to improve performance, compliance, reduce recurring issues, and strengthen proactive quality management.
  • Partner with Global Quality and cross-functional stakeholders to support development and deployment of advanced digital reporting solutions and use of artificial intelligence in CGT and enable transparent governance, decision-making, and escalation of quality and operational risks.

Required Education Level
  • Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field

Required Experience
  • Requires 8+ 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 deep expertise in global GMP regulations, guidances, and Quality Management as well as a strong understanding of industry standards and best practices across the GxP lifecycle
  • Strong leadership skills with ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment
  • Ability to lead and manage complex projects/teams within corporate objectives and project timelines
  • Proficiency utilizing project management processes / tools to lead meetings, assist with project planning and facilitate completion of tasks
  • Excellent technical writing, presentation and communication skills
  • Ability to effectively influence others within technical area of expertise
  • Outstanding facilitation, communication, and coaching/influencing skills
  • Ability to navigate through ambiguity and rapid growth and adapt to change

Other Requirements
Up to 5% travel
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
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

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