About the role
Job Description
General Summary:
The Director, Clinical Quality & Development Operations (CQDO) Operational Excellence provides strategic leadership and operational oversight of Global Clinical Operations (GCO) Ancillary Supply Management, Phase 1 Center of Excellence Alliance, Safety Distribution as well as Training & Development programs. The Director drives the execution of departmental strategy, ensuring robust processes, inspection
readiness,
and
compliance
across
all
areas.
In
addition,
the
Director
- serves
- as
- a
- key
liaison, that overall supports GCO, advancing business processes and systems to drive effectiveness, standardization, and productivity.
Key Duties and Responsibilities:
Defines and executes the overarching vision and strategy for Operational Excellence ensuring alignment with GCO and enterprise objectives.
Provide leadership and coordination across all domains to ensure operational excellence and ensure timely delivery of all goals.
Maintains inspection readiness and compliance within all domains and adherence to regulatory
standards.
Builds and maintains strong and productive relationships with key stakeholders within GCO, the Quality Organization, and LMS Organization influencing senior stakeholders and contributing to enterprise-level decision-making.
Oversees strategic vendor relationships, including selection, performance monitoring, and risk mitigation for ancillary supplies, safety submissions, and training services.
Provides strategic oversight for GCO-wide training programs, competency development, and continuous learning initiatives to build a high-performing workforce.
Establishes and tracks key performance indicators for compliance, operational efficiency, and strategies initiatives; communicates progress to senior leaderships.
Advanced leadership and execution of business
strategy
Comprehensive understanding of own discipline concepts and principles in multiple disciplines and a broad knowledge of others. Oversees multiple projects within domain in support of CQDO deliverables and is a SME for their domain.
Leverage knowledge of the potential future stakeholder landscape and to support the pipeline and identify those who will be the most influential, internal and external, to Vertex
Drive the development of innovative solutions that address evolving business needs in line with
standards
Identifies and resolves technical and operational problems, understands broader impact on the
department
Provides strategic input to solve complex problems while exercising judgment using multiple sources of information.
Deep understanding of concepts and principles in own discipline. Basic knowledge of other disciplines. Responsible for managing technical tasks or assigned as a SME for more than one
area.
Maintain understanding of the stakeholder landscape and identify areas for alignment across
stakeholders.
Communicate clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner.
Develop solutions that fully address business needs and align
standards.
Guides others either internally or externally to adopt a different point of
view.
Guided by policies and departmental plan, impacts the team’s ability to achieve
objectives.
Express views with conviction that gains support from stakeholders, even when they may have a different opinion or when the subject matter is unfamiliar.
Provides mentorship, leadership and guidance to junior level staff or FSP
employees.
As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff
Knowledge and Skills:
Advanced
understanding
of
GCP,
CFR
and
ICH
guidelines
and
Health
- Authority regulations Advanced
- ability
- to
- leverage
- knowledge
- of
- organizational
- goals
- and
- interdependencies
- with
- other functional areas to drive success Significant
- experience
- managing
- clinical
- quality
- activities
- and
- in-depth
- knowledge
- of
- clinical operations Lead cross-functional projects of high complexity with cross-functional team members and represent
Clinical
Quality
&
Development
Operations
- on
- other
- large-scale
- projects/initiatives. Develops
- strategy
- for
- their
- domain
- in
- alignment
- with
Clinical
Quality
&
Development
- Operations (CQDO), Global Clinical Operations, and Global Medicines Development & Medical Affairs program strategy and goals Leads
- major
- projects
- in
- support
- of
GCO
- infrastructure
- and
- makes
- department-wide decisions. Demonstrated
- attention
- to
- detail,
- accuracy,
- excellent
- review
- and
- analytical
- skills
- in
- a
- fast-paced environment. Expert
- knowledge
- in
- system/technical
- tools
- and
- processes Results oriented Significant
- experience
- with
- line
- management
- of
- employee Excellent
- leadership
- and
- interpersonal
- skills
- with
- an
- ability
- to
- effectively
- work
- and
- problem
- solve within a multidisciplinary team Experience
- in
- collaborating
- and
- working
- with
- global
- and
- cross-functional
- teams Excellent
- oral
- and
- written
- communication
- skills
- to
- influence,
- inform,
- or
- guide
- others
- and
- to communicate complex concepts Demonstrated
- adaptability,
- flexibility,
- independence
- and
- resourcefulness
- to
- thrive
- in
- a
- mid-sized company environment Proven successful track record in maintaining knowledge and compliance of regulatory requirements
Education and Experience: Bachelor of Science degree in a life sciences discipline
Typically
requires
10
years
of
experience,
or
the
equivalent
combination
of
education
and experience, in the biopharmaceutical industry 3
years
of
supervisor/management
experience
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:
$184,000 - $276,000
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:
Remote-Eligible
Flex Eligibility Status:
In this Remote-Eligible role, you can choose to be designated as:
1.
Remote
: work remotely five days per week and come into the office on occasion – you’re always welcome on-site;
or select
2.
Hybrid
: work remotely up to two days per week;
or select
3.
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-Remote
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, r