Director, Regulatory Compliance
Company: Vertex Pharmaceuticals
Location: Boston
Posted on: April 19, 2024
Job Description:
Director, Regulatory Compliance page is loaded Director,
Regulatory Compliance Apply locations Boston, MA time type Full
time posted on Posted 3 Days Ago job requisition id REQ-21257 Job
DescriptionGeneral Summary:The Director, Regulatory Compliance is
responsible for ensuring that Global Regulatory Affairs (GRA)
adheres to Vertex's compliance framework, and that GRA requirements
are embedded within the Quality Framework. This role provides
compliance oversight, guidance, and direction to all GRA relevant
functions, key stakeholders and leadership teams. This role
investigates departmental deviations, and oversees internal
compliance reporting, metrics and prioritization of risk based
deliverables.Key Duties and Responsibilities:
- Provides compliance oversight, guidance and direction to all
relevant employees, key stakeholders and leadership teams in
GRA
- Partners with cross-functional teams to collaborate, negotiate
and drive fact- and risk-based decision making
- Supports the Quality System as pertains to GRA, and its
applicable subsystems as assigned; oversees quality systems and
compliance
- Leads deviation reporting, investigation, and development and
closure of corrective actions and effectiveness checks
- Acts as the GRA Lead for regulatory agency, third-party and
internal inspections.
- Oversees documentation requests and interactions between GRA
and internal Quality groups, addresses findings and adheres to
health authority response timelines
- Prioritizes and oversees any remedial measures as a result of a
CAPA or other identified compliance issues
- Serves as the regulatory compliance representative on various
cross-functional teams to identify and assess risks and develop
solutions to mitigate risk
- Oversees the development of key quality metrics related to
Regulatory Compliance, tracks and reports out these metrics to
RALT
- Collaborates with GRA stakeholders to ensure compliance with
policies and regulatory requirements
- As a people manager within the organization, may have financial
accountabilities and human resource responsibilities for assigned
staff.Knowledge and Skills:
- Advanced and contemporary knowledge and expertise in
interpretation of regulations, guidelines, and precedents related
to Quality Management Systems and global regulatory and development
activities
- Demonstrated experience in a regulatory compliance role
- Results oriented; problem solving capabilities
- Exhibits strong organizational and project management skills
necessary to perform complex tasks independently and work on
multiple projects simultaneously
- Strong interpersonal and communication skills, and the ability
to effectively influence others internally/externally including
colleagues at all levels of the company, including but not limited
to GRA, Manufacturing, Clinical, Quality Assurance, Legal, and
Information Technology
- Experience with Health Authority inspections/audits and the
development and implementation of compliance corrective action
plansEducation and Experience:
- Bachelor's degree in a scientific or allied health field
- Typically requires 10 years of experience in relevant
regulatory compliance work or the equivalent combination of
education and experienceWe'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; -or select2. -On-Site and -work 5 days per week with ad hoc
flexibility. #LI-EE1 #LI-HybridCompany 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. 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 approved medicines that treat the
underlying causes of multiple chronic, life-shortening genetic
diseases - cystic fibrosis, sickle cell disease and
transfusion-dependent beta thalassemia - and continues to advance
clinical and research programs in these diseases. Vertex also has a
robust clinical pipeline of investigational therapies across a
range of modalities in other serious diseases where it has deep
insight into causal human biology, including APOL1-mediated kidney
disease, acute and neuropathic pain, type 1 diabetes, myotonic
dystrophy type 1 and alpha-1 antitrypsin deficiency .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, Latin America and the Middle East. Vertex is
consistently recognized as one of the industry's top places to
work, including 14 consecutive years on Science magazine's Top
Employers list and one of Fortune's 100 Best Companies to Work For.
For company updates and to learn more about Vertex's history of
innovation, visit www.vrtx.com -or follow us on Facebook ,
Twitter/X , - 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.
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Keywords: Vertex Pharmaceuticals, Newton , Director, Regulatory Compliance, Executive , Boston, Massachusetts
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