Job Description
GENERAL POSITION SUMMARY:
The Director, Global Quality Systems, provides strategic leadership and direction in the design, oversight of execution and effectiveness of the Vertex Quality Management System (QMS). In collaboration with quality and business partners, the position will be responsible for operationalizing an effective, efficient, compliant, and continuously improving QMS supporting Vertex activities across GxPs, product modalities including Medical Device and across geographies. This individual will demonstrate Vertex Core Values, as well as model leadership behaviors instilling a culture of quality, engagement, development, and transparency.
KEY DUTIES & RESPONSIBILITIES:
Broad responsibilities include:
- QUALITY OVERSIGHT & MANAGEMENT: Oversees and ensures deployment of the Quality Management System framework.
- EXECUTION: Actively champions and technically guides QA and operating staff to translate strategy into results.
- ALIGNMENT: Engages the organization through direct line-of-sight of their work to Vertex's V/S/M and QMS design, deployment, effectiveness and continual improvement.
- 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 Leadership Model.
Specific responsibilities include:
- Develop and implement comprehensive quality strategies to ensure Vertex QMS meets regulatory requirements across Vertex programs (strong focus on medical devices including combination product, software as a medical device, internal manufacturing of devices as well as oversight of external manufacturing of devices).
- Medical Device compliance expert; may own medical device Quality Standards; serves as consultant, trusted advisor and partner to internal customers, partners, and stakeholders.
- Global Quality Systems expert in Quality Risk Management, Event, CAPA, Change Management, Knowledge Management.
- Participates / Leads QMS Governance body responsible for strategic direction and operational oversight of Global QMS; optimizing proactive quality management, risk management, performance, and continuous improvements across internal and external GxP operations.
- Ensures overall QMS health and effectiveness through 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 QMS for meeting emerging and future business needs across modalities (e.g., cell, gene, device, vectors), GxP areas, and geographies.
- Actively champions, models and drives 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.
- Ownership of KPIs and implementation of x-GxP risk mitigation and continuous improvement initiatives.
- Change Management oversight including new/revised regulations/guidelines, operating model (internal/external), best practices/continual improvement.
- Manage QMS risk profile and ensure state of inspection readiness.
- 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, 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.
Key Technical Knowledge, Skills and Competencies:
- Broad and deep regulatory compliance (e.g. ISO 13485, FDA 21 CFR 820 QSR, EU MDR) and quality operations experience (across multiple GxP areas and modalities) with leading knowledge of industry trends and best practices for efficiency, compliance, and effectiveness.
- Demonstrated experience in design, management, and improvement of global quality management systems (QMS); must have medical device experience; prefer cross GxP (GLP, GCP, GVP, GMP and GDP) and modality experience (medical device, small molecule, cell, gene, biologics, etc.).
- Regulatory inspection management experience.
- 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 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 matrix organization.
- Creative, innovative leadership experience complemented with strong change management experience, adaptability, resourcefulness.
- Excellent communication skills and a proven track record of 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.
PREFERRED EDUCATION AND EXPERIENCE:
- M.S. (or equivalent degree) and 10+ 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.
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.
