Associate Director, Quality Systems Cell and Gene
The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the 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 Quality Management System and to drive Quality improvements.
Key Duties and Responsibilities:
- Responsible for local Quality system oversight, metrics, and improvement including change control, events, CAPA, escalation, and risk management.
- Responsible for leading and providing functional quality oversight for Change Control Management Program including functional change control board process and change advisory board
- Leads the monitoring, interpretation, and communication of QMS processes and metrics requirements including remediation plans
- Collaborate with internally and external business partners to resolve complex quality issues to ensure compliant solutions
- Provide hands-on expertise in the day to day management of data collection systems and control within the GxP Quality Management System using digital solutions.
- Responsible for strategic Quality and Risk Management 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.
- Identifies and implements continuous improvement to improve processes and make them efficient and scalable.
Knowledge and Skills:
- In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy and/or Biologics.
- Experience in product life cycle from discovery to commercials product development
- Outstanding facilitation, Communication, and Coaching/influencing skills
- Working knowledge of Operations Management principles, process and tools
- Proven Ability to lead improvement projects and project teams
- Ability to navigate through ambiguity and rapid growth and adapt to change
- Ability to be agile and effectively collaborate in a dynamic, cross-functional matrix environment
- Proven ability to identify and analyze performance indicators.
Education and Experience:
- Bachelor's degree in a scientific discipline, operations research, operations management, business administration or a related field
- Typically requires 8 years of experience or the equivalent combination of education and experience
We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid, or On-Site-Eligible role, you can choose to work:
1. On-Site and work 5 days per week with ad hoc flexibility;
2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
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.
Please note that Vertex requires COVID-19 vaccination for all employees working in the U.S. as a condition of employment at Vertex, subject to medical, religious or other accommodations or exemptions required by law. We believe this requirement is vital to keeping everyone at Vertex and in our communities safe. This requirement applies to both existing and new employees who may at any time work on-site at a Vertex facility or visit another location on behalf of Vertex (e.g., conferences, customer visits, etc.), including all remote employees. 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.