23 days ago
My client is looking for a Vice President of Regulatory and Quality who will be part of an innovative organization making a real impact on improving the quality of life globally. S/he will proactively develop and drive the execution of global regulatory strategy and quality oversight. The successful candidate will lead rapid and effective regulatory plans for the company's diagnostic products, while advising product development, and ensuring global regulatory compliance. This position also has responsibility for leading the development, management and continual improvement of the company's Quality Management System (QMS).
The Key Respeonsibilities include:
- Serving as an active member of the leadership team, working collaboratively to ensure regulatory and quality objectives are met and aligned with the company's objectives.
- Leading and mentoring the Quality Assurance and Regulatory Affairs organization, delegating appropriate levels of accountability for decision making and clearly communicating requirements and plans, cross functionally within the organization.
- Providing management and leadership to the Regulatory Affairs organization in the development and implementation of regulatory strategies and processes to inform commercialization plans approvals worldwide.
- Overseeing preparation and filing of all regulatory documents with the FDA and international regulatory agencies, within applicable regulations and guidelines.
- Developing and maintaining external relationships with relevant opinion leaders and regulatory officials.
- Working cross functionally with collaborations to support pharma partner regulatory requirements.
- Directing the development of systems, practices and processes to ensure effective ongoing review of product design or other operational and manufacturing changes.
- Providing leadership, direction and oversight to manage deviation events that may impact compliance status or create business risk.
- Strategic leadership of Adaptive’s Quality Management System (QMS).
- Facilitating management review of Adaptive’s QMS to monitor performance and create/support process enhancement initiatives to drive continuous improvement.
- Driving execution of QMS processes through programs, policies and functions that support corporate and product quality.
- Supporting specific departmental needs to maintain and improve QMS requirements for ongoing laboratory and other operational activities.
- Developing and executing quality design and quality assurance strategy for new product development, changes and improvements.
The Key Requirements include:
- BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred.
- 15+ years of progressive management experience in global quality assurance and regulatory affairs in a diagnostic, medical device or life sciences technology-driven company.
- Experience with product submissions in multiple therapeutic areas (hematology, oncology, immunology) and NGS technology highly preferred.
- Experience in strategic planning and collaboration with executives, key operational groups and external partners.
- Expertise with all phases of the product development lifecycle, including feasibility, design, development, transfer, verification and validation activities necessary for research and diagnostic product commercialization.
- Extensive experience in ISO, CLIA, CAP, CLEP, GxP and other Regulatory compliance requirements.
- Proven hands on experience in submission and approval of global regulatory filings and reporting for US (510(k)) and other key countries/regions, including CE marks.
- History of successful direct interactions and negotiations with regulatory agencies.
- Experience implementing and managing quality/compliance systems and ensuring inspection readiness.
Other Skills and Knowledge Include:
- Effective interpersonal skills including ability to lead, influence, create and work within cross-functional team environments.
- Excellent communication skills (written and verbal) and presentation skills.
- Solid knowledge of and experience in strategic planning, risk management, diagnostic product development and operations.
- Extensive ability to analyze complex situations and propose practical solutions.
- Proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.