Associate Director, Quality, Raw Materials & External Manufacturing, Cell & Genetic Therapies
Company: Vertex Pharmaceuticals
Location: Cambridge
Posted on: May 12, 2022
Job Description:
Job DescriptionGeneral SummaryThe Associate Director, Quality of
Raw Material External Manufacturing, responsible for the quality
oversight of critical components Contract Development and
Manufacturing Organizations (CDMOs) for Cell & Genetic Programs
through the lifecycle development process. This includes quality
oversight for the selection, qualification and routine monitoring
of Contract manufacturers and laboratories. The quality role will
closely partner with operational stakeholders and participate in
associated governance for the successful planning and execution of
program CMC strategy. The successful candidate will be a key member
of the Vertex Cell & Genetic Therapy Quality Team.The role is
responsible for collaborating with internal stakeholders to develop
and maintain relationships and drive compliance and continuous
improvement activities within critical component contract
manufacturers and associated laboratories.Key Duties &
ResponsibilitiesBe the Quality expert for critical component
contract development and manufacturing organizations.
- Participate in cross functional teams to determine enhancements
to quality systems and support the closure of compliance gaps at
raw material contract manufacturers.
- Build strategic relationships with CDMOs within the Quality
organization and participates in Business Review Meetings to ensure
Quality issues are raised and addressed, as necessary.
- Negotiate, monitor and maintain Quality Agreements with
CMOs.
- Liaises with cross-functional teams for external quality
commercial operations in support of GMP manufacturing and testing
activities, including disposition of critical raw materials.
- Monitors quality processes, metrics and drive quality
remediation and continuous improvement activities.
- Work closely with the Audit and Inspection Quality Function to
establish the audit strategy for Auditing and Performance oversight
and support technical site audits including preparation for
regulatory inspections.
- Establishment of vendor quality oversight processes including
qualification, risk categorization and routine monitoring.
- Provide guidance and support through Quality representation in
relevant geographies at periodic intervals on site at the
CDMOs.
- Supports root cause analysis and product impact assessments for
investigations resulting from deviations and OOS.
- Responsible for the quality review and approval of critical
component change controls for development and commercial processes,
assess impact and implementation activities.
- Participate in Cell & Genetic Program and Quality
projects.Required Knowledge/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
- Broad understanding of regulatory environment including quality
systems, compliance and strategy.
- Broad technical knowledge in Cell technology, aseptic
manufacturing technology, analytical assays, cell & genetic
therapies/Biologics processing, fill/finish and testing.
- Ability to lead improvement projects - experience with Root
Cause Analysis, data analytics, and other Operational Excellence
experience, such as LEAN, DMAIC, Six Sigma.
- Excellent communication skills and a proven track record
Influencing/building/promoting a culture of Quality and
Excellence.
- Ability to apply risk management principles to decision making
and operational priorities.
- Critical Thinking and Problem-Solving skills
- Strong leadership and an innate ability to collaborate and
build relationships.Required Education Level
- Bachelor's degree in a biotech/Lifesciences field.
- Master's degree or relevant comparable background.
- Typically requires 6+ years of relevant industry experience
such as manufacturing, quality assurance, and/or quality control in
biotechnology/regulated pharmaceutical environmentWe'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. Hybrid and work
remotely up to two days per week on regularly scheduled days; or
select2. On-Site work 5 days per week with ad hoc
flexibility.#LI-ND1 #LI-HybridCompany InformationVertex 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.
Keywords: Vertex Pharmaceuticals, Cambridge , Associate Director, Quality, Raw Materials & External Manufacturing, Cell & Genetic Therapies, Healthcare , Cambridge, Massachusetts
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