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Associate Director Inspection Readiness Remote

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Wednesday, July 10, 2024

Job Description

GENERAL POSITION SUMMARY:

The Associate Director of Inspection Readiness is dedicated for developing and providing necessary tools, systems, workflows, and metrics to drive optimal execution, monitoring and delivery of inspection readiness activities across all programs within the Vertex clinical portfolio. They are responsible for maintaining and continuously improving business process documentation to drive effectiveness, standardization, harmonization, scalability, and improved productivity.

This role functions both as a leader and manager potentially overseeing staff and inspection readiness teams to ensure deliverables are met as well as serving as a subject matter expert on inspection readiness processes, identifying process improvement opportunities and supporting key stakeholders on procedural development and refinement activities.

This role provides governance to the overall architecture, workflows, templates, libraries and technologies that will ultimately form the Vertex Strategic Inspection Readiness Framework and Inspection Readiness Playbook and are responsible for ensuring these have the appropriate change management, communication and training plans in place for study teams.

Through this framework they will develop program and study specific inspection risk profiles for targeted risk assessments with associated workstream and mitigation strategies. They will provide the necessary support to RDQA Program Quality Leads, business partners and key stakeholders to ensure ongoing monitoring and reporting of all inspection activities and their perceived risks 1 year prior to filing so that teams and programs can quickly reach a state of inspection readiness in anticipation of a real inspection.

KEY RESPONSIBILITIES:

  • Responsible for independently evaluating functions, systems and processes and identifying process gaps and inefficiencies and leveraging technology, process and training to find the appropriate solutions to fix these.
  • Provides strategic input, technical and project management advice and support to various functions across GMDA and QA using project management standards and best practices.
  • Works with cross functional department heads and executive management to evaluate, plan, project manage, implement and operationalize solutions to meet both the corporate strategic business inspection readiness needs as well as operational pain points ensuring cross functional consistency and alignment, process adherence, data governance, communication and messaging, operational excellence training and appropriate application of these project and change management tools and best practices.
  • Portfolio Management and oversight of all programs entering an inspection planning, readiness and preparedness phase (1 year prior to submission) ensuring these are adequately resourced for optimal delivery and execution as well as appropriate knowledge management and transferring of lessons learned from one program to the next in the spirit of continuous improvement and trending analyses.
  • Collaborates with colleagues from QA, Audits and Inspection Management (AIM) and GMDA business partners to reach an overall and ongoing state of inspection readiness through the use of data-driven inferences, analyses of data outputs, findings and observations from mock inspections, PI audits, Quality reviews and prior inspection findings, risk and issue identification to form targeted risk-based inspection readiness workstreams and develop inspection and interview prep training plans and systematic trend analyses and process improvement techniques.
  • May be responsible for the management of multiple corporate level, large-scale process improvement, enhancement and complex change management initiatives focused around operational excellence and organizational maturity.
  • Serves as the key conduit around communications within project teams to foster transparency and understanding between groups.
  • Identifies appropriate cross-functional project representatives and timing for engagement.
  • Conducts extensive research and investigations around proposed changes in order to be able to understand root causes that will help identify gaps in process, outliers, anomalies, trends and patterns.
  • May serve as Subject Matter Expert (SME) for high complexity projects and initiatives.
  • May have line management responsibilities

GENERAL RESPONSIBILITIES AND REQUIRED SKILLS:

  • Ability to facilitate cross-functional communication, managing project teams to be productive in a fast-paced and changing environment.
  • Ability to communicate effectively with senior management and to partner across and within various functional departments.
  • Ability to influence teams and drive decision-making in a collaborative working environment.
  • Experience running and/ or working on projects using: Software Systems Development Lifecycle (SDLC), Product Lifecycle Management (PLM), Lean, Agile (SCRUM/Kanban) or equivalent project management methodologies and best practices to effectively manage projects/teams of significant scope and complexity.
  • Strong consultative, listening and analytical skills; able to be data-driven, forward-thinking and engage in innovative problem solving and solutions development.
  • Working knowledge of clinical trial methodology and operations.
  • Strong proficiency of efficient and effective project management, change management and process mapping methodologies.
  • Places a high value on developing and cultivating strong working relationships both internally and externally through business relationship management best practices.
  • Works independently, reporting status and elevating issues to management and key stakeholders where appropriate.
  • Demonstrated proficiency using Microsoft Office applications required (including MS Visio, Excel, MS Project, SharePoint).

PREFERRED EDUCATION AND EXPERIENCE:

  • Bachelor’s degree and approximately 7-8 years of experience in clinical research with a focus clinical/project management experience and process improvement, or equivalent.
  • Experience in a clinical research, regulated product development, or health care environment.

Pay Range:

$149,600 - $224,400

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 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.

At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

Flex Designation:

Remote-Eligible

Flex Eligibility Status:

In this Remote-Eligible role, you can choose to be designated as:
1. Remote: work remotely five days per week and come into the office on occasion – you’re always welcome on-site; or select
2. Hybrid: work remotely up to two days per week; or select
3. 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