Director, Quality Assurance Technology Vendor Management Job at Vertex Pharmaceuticals
Job Description
General Summary:
The Director of Technology Vendor Management provides strategic leadership and direction in the design, oversight of execution and effectiveness of Technology Vendor Management Program for all GxP areas. This individual serves as the Technology Vendor Quality System owner in the design, deployment, oversight, and monitoring of the health of Technology Vendor Management program. This includes establishing processes for monitoring technology vendor performance and effectiveness across the operational areas including GxP disciplines. This individual will establish the required metrics and KPIs as well as assess the trends to identify improvement opportunities to maximize value, impact and delivery in assuring compliance, excellence in quality and readiness for future needs.
The Director of Technology Vendor Management will work closely with each operational Quality area, as well as Global Vendor Management team and business partners such as DTE, to ensure a balance of standardization, fit-for-purpose application, oversight, and management of vendors.
The Technology Vendor Management will partner with the Quality Leadership Team, quality governance bodies and stakeholders across operational areas to facilitate the evaluation of the health of the quality system and identification of vendor risks that will require assessment as well as identification of mitigation and improvement opportunities.
The Director of Technology Vendor Management will be one who has demonstrated success in engaging teams and stakeholders across functional areas for collaboration in advancing quality outcomes and operational excellence, balancing design of models with practicality of application for effectiveness of outcomes, and in implementing progressive quality management oversight systems. Experience in quality management systems in a regulated (e.g. GxP) environment is preferred.
This individual will report to the Senior Director, Quality Information Systems Management and will work closely with other Quality leadership members, process and systems owners, and across quality and operational teams to build scalable Quality Systems and processes and ensure consistency in execution across all functional GxP areas.
This individual will demonstrate Vertex Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency.
Key Duties and Responsibilities:
Broad responsibilities include:
OPERATIONS MANAGEMENT: Oversees and ensures effectiveness of Technology Vendors performance, build out and maintain dashboards and assign rolling risk in partnership with stakeholders.
ALIGNMENT: Engages the organization through direct line-of-sight of their work to Vertex's vision 2030 and cross-QA operational performance in delivery of strategic and business goals/objectives
EXECUTION: Actively champions and technically guides process owners and stakeholders across Quality and business areas to translate strategy into results
ROLE MODELLING: Consistently demonstrates an ongoing commitment to achievement of Vertex and QA goals, as well as the success of all team members consistent with the Vertex phenotype
Specific responsibilities include:
Serves as Technology Quality Systems Owner for Vendor Management with accountability for the design and execution, providing tools, templates, systems, and training, as well as, strategic direction to proactive monitoring.
- Provides strategic direction in the continual advancement of the Technology Vendor Management program.
- Ensures effectiveness of the Technology Vendor Management program through leading practices, end-to-end process design, deployment, oversight monitoring, assessment of fitness for enabling business objectives and quality outcomes in an evolving, growing, and matrixed organization.
- Ensures sustainability, scalability, and efficiency of the Technology Vendor Management program for meeting emerging and future business needs across modalities (e.g., cell, gene, device, vectors), GxP areas, and geographies.
- Actively champions, models and drives for continual improvement, excellence in execution, and transparency of information to bring insights and leading practices for enabling commercial success and pipeline advancement through proactive and effective quality management.
- This role will also support the maturity of the quality governance/management review process for assessment of regulatory intelligence, best practices, risk mitigation, continual improvement, and the assessment of the health of the global QMS.
- Partners with the business and local quality systems owners in determination of needs for tools, metrics, mechanisms, and systems enabling individual manager accountability and ownership for decision making in ensuring operational performance across their scope of responsibility.
- Serves as a change agent fostering an enterprise mindset and culture of quality across sites, functions, partners, and business units while integrating and balancing needs across product types, technologies, locations and GxP areas.
- Provides leadership coordination and direction to benchmarking with external peers and industry for establishing best practices in global quality management systems and monitoring of the external environment for leading practices, emerging trends, and projection of future industry.
- Creates a culture of inclusiveness, partnership, opportunity, development, engagement, and performance for team and more broadly across QA and stakeholder groups
- Models leadership, transparency, openness, respect, and partnership across interactions with staff, peers, customers, and stakeholder groups
- Partners effectively across QA for ensuring a collaborative, progressive and productive culture across quality that engages, develops, retains, and advances staff, and delivers excellence in talent management and succession readiness for organizational effectiveness and sustainability
- Represents QA organization and serves as consultant, trusted advisor and partner to internal customers, partners, and stakeholders
Knowledge and Skills:
Leadership Skills:
- Learn, Teach, Develop
- Lead by example
- Foster exemptional collaboration
- Drive breakthrough results
- Promote enterprise thinking
Technical Knowledge, Skills and Competencies:
- Broad and deep regulatory compliance and quality management experience (across multiple GxP areas) with leading knowledge of industry trends and best practices for efficiency, compliance, and effectiveness
- Demonstrated experience in design, management, and improvement of global quality systems/processes
- Regulatory inspection management experience; or experience in regulatory agency with a focus on compliance
- Experience at a Sponsor company with responsibility for change management initiatives, quality or process governance, vendor/alliance management or similar experience of scope and breadth
- Broad and deep operational and project management knowledge and experience
- Demonstrated strategic planning and execution skills required
- Proven ability to design/evolve and /or implement processes and KPIs that are fit-for-purpose manner enabling effectiveness and assessment of the health of the global QMS
- Current knowledge of industry trends and best practices- for progressive quality management in a regulated environment
- Developing individuals and teams; proven leadership capabilities within multi-level organization
- Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness
- Excellent communication skills and a proven track record Influencing/building/promoting a culture of Quality and Excellence
- Operational Excellence experience with proven ability to lead improvement projects-Experience with Root Cause Analysis and other Operational Excellence experience, such as LEAN, DMAIC, Six Sigma
- Strong problem solving and critical thinking skills, accompanied by Analytical thinking/Data Analysis skills required to make sound decisions
Education and Experience:
- M.S. (or equivalent degree) and 8 +years of relevant work experience, or B.S. in a scientific or allied health field (or equivalent degree) and 12+ years of relevant work experience, or relevant comparable background
- Professional association membership and participation preferred, not required (for example: RAPS; Lean Six Sigma training/certification; SQA; ASQ; DIA)
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. On-Site and work 5 days per week with ad hoc flexibility;
2. Hybrid and work remotely up to two days per week on regularly scheduled days; or select
#LI-AR1 #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, 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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