Sr. Director, Quality Assurance
Every immune system has a story to tell— the key is knowing how to listen. Our goal is to meaningfully improve people's lives by learning from the wisdom of their adaptive immune systems. It's a bold objective that we're uniquely built to achieve.
At Adaptive, you'll be challenged, you'll be inspired, and you'll be part of an innovative organization making a real impact on improving the quality of life globally. No matter what your role is, you'll find a diverse, team-driven, fun culture where your contributions truly count.
The Sr. Director, Quality Assurance will lead and execute the Quality Assurance strategy for Adaptive. Reporting to the Vice President, Regulatory Affairs and Quality Assurance, the Director, Quality Assurance will lead the development, management and continual improvement of Adaptive's Quality Management System (QMS). This individual will oversee all policies, procedures, and practices that establish quality systems compliant with current and expected requirements of various regulatory agencies. In addition, this individual willoversee the implementation of quality systems and controls to maintain good laboratory practice (GLP) and Good Manufacturing Practices (GMP) requirements in Adaptive's new research / non-clinical facility.
- Serve as a key leader at Adaptive, working collaboratively to ensure Quality Assurance objectives are met and aligned withAdaptive's operational and regulatory objectives.
- Lead and mentor the Quality Assurance organization including Quality Assurance, Quality Assistance, Document Control and Training teams ensuring appropriate levels of accountability for decision making and clearly communicating cross functionally within the organization.
- Provide strategic leadership of Adaptive's Quality Management System (QMS).
- Partner with Regulatory Affairs leadership to set and maintain regulatory policies and quality standards for all quality systems and ensure compliance with applicable regulations worldwide.
- Facilitate management review of Adaptive's QMS to monitor performance and create/support process enhancement initiatives todrive continuous improvement.
- Drive execution of QMS processes through programs, policies and functions that support corporate and product quality.
- Support specific departmental needs to maintain and improve QMS requirements for ongoing laboratory and other operational activities.
- Collaborate cross-functionally with internal departments on strategy development, risk assessments and implementation of quality principles and regulatory requirements.
- Develop and execute quality design and quality assurance strategy for new product development, changes and improvements.
- In support of the quality system, provide effective leadership support, training and guidance to all company personnel.
- BA/BS undergraduate degree in life sciences. MS, PhD or other relevant advanced degree strongly preferred.
- 10+ years of progressive management experience in quality assurance in a diagnostic, medical device or life sciences technology driven company.
- Experience in GxP and other Regulatory compliance (Laboratory is ISO 13485 and CAP accredited)
- Experience in multiple therapeutic areas (hematology, oncology, immunology) and NGS technology preferred.
- Experience in strategic planning and collaboration cross-functionally, including operational, R&D and regulatory groups.
- Experience with all phases of the product development lifecycle, including feasibility, design, development, transfer, verification and validation activities necessary for research and diagnostic product commercialization.
- Experience with software-related regulation, ideally IEC 62304.
- Familiarity with agile and waterfall software development lifecycle (SDLC) approaches.
- Ability to operate in a hybrid world of operational (CLIA/LDT) and device (FDA/CE) regulation.
- 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.
- Experience implementing and managing quality/compliance systems and ensuring inspection readiness.
- High level of personal and professional integrity and trustworthiness with strong work ethic.
- Excellent communication (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.
- Ability to develop and manage a high-performance team focused on accountability and exceeding expectations.
- Ability to lead, influence, create and work within cross-functional team environments.
- Assertive, take-charge, proven manager with a strong results orientation, positive "can do" attitude and a sense of urgency to get things done.