Vertex Pharmaceuticals
Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)
Boston, MA · Director
Sponsorship not specified$148k-$222kDetected 12 days ago
Project ManagementAuditingOperations ManagementRecruitingGMPCRISPRResearchLeadershipCommunicationWritingInternal AuditGxP
About the role
- This position reports directly to the Director of Quality.
- The responsibilities of this position may include, but are not limited to, the following:
- Responsible for leading and providing functional process oversight for APQR and QPQA
Responsibilities
- The Quality Systems Associate Director supports strategic design of and ensures tactical execution of quality systems, risk management, and quality culture across the Vertex Cell and Gene Therapy (VCGT) organization.
- Monitor and support the quality risk management program items associated with CGT. Identify and implement continuous improvement projects to improve processes and make them efficient and scalable
- Collaborate with Global Process owner to identify and implement DI continuous improvement projects to mature processes and make them efficient and scalable
- Responsible for strategic, Risk Management monitoring support, and Data Integrity initiatives and activities to drive prioritization and in-support continuous improvement across VCGT QMS/Compliance processes
Requirements
- Experience in product life cycle from discovery to commercial product development
- Required Knowledge/Skills
- Broad and deep expertise in global GMP regulations, guidances, and Quality Management Systems, as well as a strong understanding of industry standards and best practices across the GxP lifecycle
- Ability to assess impact across multiple procedures and systems
- Proficiency utilizing project management processes / tools to lead meetings, assist with project planning and facilitate completion of tasks
- Ability to effectively influence others within technical area of expertise
- Ability to navigate through ambiguity and rapid growth and adapt to change
- Proven ability to identify and analyze performance indicators.
Compensation
- $148,000 - $222,000
- 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.
Benefits
- This role is eligible for an annual bonus and annual equity awards.
Company info
- 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
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