Sr. Director, RA/QA Strategy & Business Integration in Morrisville, North Carolina at Foundation Medicine, Inc.

About the Job:

Foundation Medicine is seeking a strategic and collaborative leader to serve as Senior Director, RA/QA Strategy & Business Integration. This role acts as the primary interface between Regulatory Affairs/Quality Assurance (RA/QA) and cross-functional internal business partners, including Product, R&D, and Operations as well as external business partners.

The role is a strategic enabler of innovation, playing a central role in shaping both regulatory and product strategy. The Senior Director ensures quality and regulatory perspectives actively inform development pathways, partnerships, and go-to-market decisions. They will also represent FMI externally, engaging with biopharma partners and at industry forums, while positioning RA/QA as a proactive driver of speed,

innovation, and competitive advantage.

Key Responsibilities:

• Strategic Leadership & Business Partnership
  • Serve as the primary RA/QA leader interfacing with Product, R&D, and Operations, shaping regulatory and product strategy
  • Drive early and impactful integration of RA/QA into product development, strategic planning, and decision-making
  • Guide development pathways to balance innovation, compliance, speed, and scalability
  • Position RA/QA as a strategic enabler of innovation and competitive advantage
• Cross-Functional Leadership & Governance
  • Lead prioritization of RA/QA engagement based on business impact and strategic importance
  • Orchestrate the right expertise across RA/QA (e.g., Software, Device, Laboratory Quality) to support key initiatives
  • Ensure consistent, risk-based application of quality and regulatory frameworks across the enterprise
  • Act as escalation point for high-impact or ambiguous regulatory and quality decisions
• Operational Excellence & Strategic Enablement
  • Drive simplification and optimization of RA/QA processes to accelerate development timelines
  • Align RA/QA resources to highest-value initiatives, enabling focus on innovation and strategic priorities
  • Anticipate emerging regulatory trends, risks, and business needs to inform forward-looking strategy
• External Engagement & Influence
  • Represent FMI with biopharma partners and in industry forums, shaping external perspectives on regulatory and quality strategy
  • Build strong relationships with senior internal and external stakeholders
  • Influence key decisions to ensure optimal balance between compliance, innovation, speed, and market impact
  • Comply with FMI's attendance policies

Qualifications:

Basic Qualifications:

• Bachelors degree in Life Sciences, Engineering, or a related discipline
• 12+ years of experience in Quality Assurance and Regulatory Affairs in biotech, diagnostics, or medical device environments
• Demonstrated experience shaping regulatory strategies and supporting product development in regulated environments (e.g., FDA, CLIA, CAP, IVDR)
• Proven track record of influencing cross-functional decision-making across Product, R&D, and Operations
• Experience engaging with external stakeholders (e.g., biopharma partners, regulatory authorities, or industry forums)
• 5+ years of leadership experience, including leading through influence in a matrixed organization

Preferred Qualifications:

• Preferred Qualifications
• Advanced degree (PhD, MS, MBA, or equivalent)
• Deep expertise in regulatory strategy across the product lifecycle, ideally in diagnostics, IVD, or precision medicine
• Experience shaping complex product development programs in close partnership with Product and R&D
• Demonstrated ability to influence senior leaders and drive enterprise-level decisions in a matrixed environment
• Experience representing an organization externally as a thought leader in regulatory and quality strategy
• Track record of building or evolving QA/RA operating models, governance, or strategic capabilities
• Strong understanding of global regulatory environments (e.g., FDA, IVDR) and risk-based decision-making frameworks
• Key Competencies
• Strategic thinking and enterprise mindset
• Exceptional communication and executive presence
• Cross-functional leadership and collaboration
• Strong judgment and decision-making in complex environments
• Continuous improvement and operational excellence
• Understanding of HIPAA and the importance of patient data privacy
• Commitment to reflect FMIs values: Integrity, Courage, and Passion

The expected salary range for this position based on the primary location of Remote is $230,800 - $288,500 per year. The salary range is commensurate with Foundation Medicines compensation practice and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for Foundation Medicine's benefits.

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