Job Description
The Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence process as well as the inspection readiness process. The position must work cross-functionally across the organization and have excellent communication and collaboration skills.
Key Duties & Responsibilities
- Responsible for triaging and assessing regulatory surveillance items such as new regulations or guidance.
- Leads cross-functional teams to assess the impact of these regulations to the Vertex organization and associated quality systems and processes.
- Provide guidance and expertise to the team on regulatory expectations standard practices in the industry and options for implementation.
- Supports inspection and submission readiness by tracking and reporting progress on various metrics and programs.
- Reports out on KPIs and metrics to communicate status and risks.
Required Education Level
Bachelors degree in a scientific discipline operations research operations management or a related field
Required Experience
Typically requires 6 years of relevant experience or the equivalent combination of education and experience
Required Knowledge/Skills
Superb facilitation organization communication and influencing skills with proven ability to lead teams
Excellent knowledge of global GMP requirements and regulations
Ability to evaluate quality matters and make decisions utilizing risk-based approach
Proven ability to identify and analyze performance indicators
Strong technical knowledge including but not limited to: regulatory inspections and compliance
Pay Range
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employment-related information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Required Experience:
Senior Manager
Job DescriptionThe Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence process as well as the inspection readiness process. The position must work cross-functionally across the organization and have excellent communication and collaboration skills.Key Dut...
Job Description
The Sr Manager for regulatory surveillance will support the regulatory surveillance and intelligence process as well as the inspection readiness process. The position must work cross-functionally across the organization and have excellent communication and collaboration skills.
Key Duties & Responsibilities
- Responsible for triaging and assessing regulatory surveillance items such as new regulations or guidance.
- Leads cross-functional teams to assess the impact of these regulations to the Vertex organization and associated quality systems and processes.
- Provide guidance and expertise to the team on regulatory expectations standard practices in the industry and options for implementation.
- Supports inspection and submission readiness by tracking and reporting progress on various metrics and programs.
- Reports out on KPIs and metrics to communicate status and risks.
Required Education Level
Bachelors degree in a scientific discipline operations research operations management or a related field
Required Experience
Typically requires 6 years of relevant experience or the equivalent combination of education and experience
Required Knowledge/Skills
Superb facilitation organization communication and influencing skills with proven ability to lead teams
Excellent knowledge of global GMP requirements and regulations
Ability to evaluate quality matters and make decisions utilizing risk-based approach
Proven ability to identify and analyze performance indicators
Strong technical knowledge including but not limited to: regulatory inspections and compliance
Pay Range
Requisition Disclaimer
This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (Vertex). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation medical benefits fringe benefits and other terms and conditions of employment shall be presented by the third-party agency partner upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting. The actual pay rate will be based on a number of factors including skills competencies experience location and/or being pursued and other job-related factors permitted by addition this role will be eligible for overtime pay in accordance with federal and state requirements
By applying for this position you agree to the Atrium Terms and Conditions and you direct Atrium to share your application materials which may include your CV/Resume email address or phone number with Vertex. For more information on how Vertex handles your personal data related to your job application please see Vertexs Careers Privacy Notice. Agreeing to the Atrium Terms and Conditions includes permission to use the email address and mobile phone number you provide during the application process or throughout the duration of your prospective or actual employment to notify you of job openings profiles articles news and other employment-related information as well as to notify you of special promotions or additional products and services offered by us or our affiliates and partners
(collectively Atrium Alerts). Atrium Alerts may be sent by email phone or text message. Your personal information will be safely stored within the Atrium & Vertex databases. Atrium does not sell your personal information to third parties. Text message and data rates may apply. To OPT OUT of text messaging or to modify your communication preferences for Atrium Alerts at any time please contact Atrium at .
If you do not agree with the Atrium Terms and Conditions you can still complete your application for this position by emailing your resume to our team at Please include the job title in the subject of your email.
No C2C or Third-Party Vendors
Required Experience:
Senior Manager
View more
View less