Vertex Pharmaceuticals
Senior Manager, Regulatory Compliance
Vertex Pharmaceuticals, Boston, Massachusetts, us, 02298
Job Description
General Summary:
The Regulatory Compliance Senior Manager works to provide compliance oversight, guidance and direction to all relevant Regulatory Affairs functions, key stakeholders and leadership teams primarily through process development and refinement. The incumbent will be responsible for championing these processes throughout the teams, working with Senior Management to prioritize process work, identifying authors and adapting to an evolving global landscape. This incumbent will help define compliance standards via policies and procedures, elevate compliance matters to internal stakeholders and deliver compliance training and communications as necessary.
Key Duties and Responsibilities:
Provides compliance oversight, guidance and direction to all relevant employees, key stakeholders and leadership teams.
Partners with cross-functional teams to collaborate, negotiate and drive fact- and risk-based decision making.
Assists teams in identifying areas where compliance input and escalation is required and ensure consistency in the application of criteria across the Company.
Serves on various cross-functional teams and forums as appropriate to identify and assess risks and develop solutions to mitigate risk
Elevates compliance matters to internal stakeholders
Collaborates with Global Regulatory Affairs stakeholders to ensure compliance with policies and regulatory requirements
Delivers compliance training and communications as necessary.
Supports the Quality System as pertains to GRA, and its applicable subsystems as assigned; oversight of quality systems and compliance.
Acts as the Global Regulatory Affairs Lead for quality framework for Standard Operating Procedures and Work Instructions; liaison between stakeholders and Quality Document Control.
Identifies procedural gaps and areas for improvements and work with Senior Management to prioritize process work, and identify authors
Knowledge and Skills:
In-depth conceptual knowledge and experience in interpretation of regulations, guidelines, and precedents related to Quality Management Systems and global regulatory and development activities
Strong communication and interpersonal skills to explain difficult information and build alignment
Experience in cross-functional process development
Results-oriented problem solver
Exhibits strong organizational and project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously
Education and Experience:
Bachelor's degree in a scientific or allied health field
Typically requires 6 years of experience including cross-functional experience in Clinical Development, Biostatistics, Regulatory Affairs and/or Quality Assurance at a pharmaceutical or biotech company, 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. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
#LI-AR1 #LI-Hybrid
Flex Designation: Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. 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.
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.
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
#J-18808-Ljbffr
General Summary:
The Regulatory Compliance Senior Manager works to provide compliance oversight, guidance and direction to all relevant Regulatory Affairs functions, key stakeholders and leadership teams primarily through process development and refinement. The incumbent will be responsible for championing these processes throughout the teams, working with Senior Management to prioritize process work, identifying authors and adapting to an evolving global landscape. This incumbent will help define compliance standards via policies and procedures, elevate compliance matters to internal stakeholders and deliver compliance training and communications as necessary.
Key Duties and Responsibilities:
Provides compliance oversight, guidance and direction to all relevant employees, key stakeholders and leadership teams.
Partners with cross-functional teams to collaborate, negotiate and drive fact- and risk-based decision making.
Assists teams in identifying areas where compliance input and escalation is required and ensure consistency in the application of criteria across the Company.
Serves on various cross-functional teams and forums as appropriate to identify and assess risks and develop solutions to mitigate risk
Elevates compliance matters to internal stakeholders
Collaborates with Global Regulatory Affairs stakeholders to ensure compliance with policies and regulatory requirements
Delivers compliance training and communications as necessary.
Supports the Quality System as pertains to GRA, and its applicable subsystems as assigned; oversight of quality systems and compliance.
Acts as the Global Regulatory Affairs Lead for quality framework for Standard Operating Procedures and Work Instructions; liaison between stakeholders and Quality Document Control.
Identifies procedural gaps and areas for improvements and work with Senior Management to prioritize process work, and identify authors
Knowledge and Skills:
In-depth conceptual knowledge and experience in interpretation of regulations, guidelines, and precedents related to Quality Management Systems and global regulatory and development activities
Strong communication and interpersonal skills to explain difficult information and build alignment
Experience in cross-functional process development
Results-oriented problem solver
Exhibits strong organizational and project management skills necessary to perform complex tasks independently and work on multiple projects simultaneously
Education and Experience:
Bachelor's degree in a scientific or allied health field
Typically requires 6 years of experience including cross-functional experience in Clinical Development, Biostatistics, Regulatory Affairs and/or Quality Assurance at a pharmaceutical or biotech company, 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. Hybrid and work remotely up to two days per week; or select
2. On-Site and work 5 days per week with ad hoc flexibility.
#LI-AR1 #LI-Hybrid
Flex Designation: Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. 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.
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.
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
#J-18808-Ljbffr