Associate Director, Quality Systems Cell and Gene
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: March 20, 2023
Job Description:
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Boston, MA time type Full time posted on Posted 2 Days Ago job
requisition id REQ-18382 Job DescriptionGeneral Summary: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 #LI-AR1 #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. 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. Similar Jobs (5) Director, Quality
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Posted 8 Days Ago About Us Help Us Achieve Our Mission Vertex is a
global biotechnology company that invests in scientific innovation
to create transformative medicines for people with serious
diseases. The company has multiple approved medicines that treat
the underlying cause of cystic fibrosis (CF) - a rare,
life-threatening genetic disease - and has several ongoing clinical
and research programs in CF. Beyond CF, Vertex has a robust
pipeline of investigational small molecule, cell and genetic
therapies in other serious diseases where it has deep insight into
causal human biology, including sickle cell disease, beta
thalassemia, APOL1-mediated kidney disease, pain, type 1 diabetes,
alpha-1 antitrypsin deficiency and Duchenne muscular
dystrophy.Founded in 1989 in Cambridge, Mass., Vertex's global
headquarters is now located in Boston's Innovation District and its
international headquarters is in London. Additionally, the company
has research and development sites and commercial offices in North
America, Europe, Australia and Latin America. Vertex is
consistently recognized as one of the industry's top places to
work, including 13 consecutive years on Science magazine's Top
Employers list and one of Fortune's Best Workplaces in
Biotechnology and Pharmaceuticals and Best Workplaces for Women.
For company updates and to learn more about Vertex's history of
innovation, visit www.vrtx.com -or follow us on Facebook , -
Twitter , - LinkedIn , - YouTube -and - Instagram . The diversity
and authenticity of our people is part of what makes Vertex unique,
and we recognize that each employee brings diverse perspectives and
strengths. By embracing those strengths and celebrating
differences, we are fostering an inclusive culture where each of us
can bring our authentic selves to work, inspire innovation
together, and change people's lives. -Our vision is clear: to be
the place where an authentic, diverse mix of talent want to come,
to stay, and do their best work. ALERT: If you have signed up for
Job Alerts, please be aware that Job Alert Matches are currently
not working. During this time, please check our careers site
regularly for all open opportunities. We apologize for this systems
issue and hope for it to be resolved soon.
Keywords: Vertex Pharmaceuticals, Boston , Associate Director, Quality Systems Cell and Gene, Executive , Boston, Massachusetts
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