GCP Operational Quality Associate Director
- Compensation
- Not disclosed
- Location
- Boston, MA
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 10+ years
- Category
- Not specified
- Posted
Skills
Must have
- · Bachelor’s Degree in a scientific or allied health field
- · Typically requires 10 years’ experience or the equivalent combination of education and experience
- · Strong knowledge of data integrity principles and ALCOA
- 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, dem
- Pay Range:
- 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 a
- Flex Designation:
- 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.
- #LI-Hybrid
- 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,
- 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 th
Full description
Job DescriptionGeneral position summary:
Biomarker Operational Quality Associate director provides Biomarker quality leadership and oversight across GxPs-related to research and development, implementation into clinical trials and potential commercialization of clinical biomarkers into IVDs. The incumbent will collaborate with business partners and GCP Operational Quality to drive quality outcomes and operational excellence, through supporting operational management oversight for these areas.
The Associate Director will ensure that quality oversight activities maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs. The Associate director, Biomarkers Operational Quality will also collaborate with the Biomarker Operations team to review and support the development of meaningful quality indicators and metrics to permit ongoing evaluation of process and quality system health and identification of risks.
This position reports directly to the Director, GCP Biomarker Operational Quality and work closely with other Quality members to ensure appropriate GxP compliance and consistency in execution of fit-for-purpose Quality oversight across programs and products.
Key Responsibilities:
The responsibilities of this position may include, but are not limited to, the following:
Biomarkers
·Partners with appropriate quality/compliance oversight of preclinical and clinical activities (fit-for-purpose validations and associated processes) across modalities in collaboration with Clinical Biomarkers and with other internal stakeholders in the business and Quality
·Contributes in Regulatory Document reviews, including BBs, INDs, IDEs, and TMFs, identifying any potential risks or gaps.
·Provides input in development of requested and for-cause GCLP and GCP Biomarker audit scope/focus for vendor audits.
·Supports business initiatives involving processes, procedures, regulations and tools intended to support non-clinical activities.
·Participates in strategic cross-functional initiatives to improve compliance to regulatory requirements, standards and internal Vertex policies.
·Identifies and anticipates potential compliance issues that may impact the ability to meet business goals; develops and implements methods of improvement and resolution in a pragmatic and effective manner.
·Contributes to proactive reporting of significant quality issues related to Vertex Preclinical product development, ensuring an aligned Quality point-of-view is represented.
·Contributes to proactive inspection readiness activities for processes that impact product development, including conducting inspection readiness quality assessments of GLP/GCP Biomarker studies, as requested.