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:
- Bachelor’s 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 FMI’s 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.
#LI-Remote
About UsSkills Required
- Bachelor's 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
- 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
- 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
- Understanding of HIPAA and the importance of patient data privacy
Foundation Medicine Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Foundation Medicine and has not been reviewed or approved by Foundation Medicine.
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Strong & Reliable Incentives — Bonuses and long-term incentives are described as competitive and a meaningful component of total rewards. Annual bonuses tied to personal and company outcomes feature alongside base pay.
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Healthcare Strength — Comprehensive medical and dental coverage is a core element of the package. Health plans are positioned as robust and well-rounded rather than minimal.
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Leave & Time Off Breadth — Time-off offerings include flexible or unlimited PTO and paid parental leave, supporting work–life balance. Extra paid downtime has been referenced alongside standard PTO.
Foundation Medicine Insights
What We Do
Foundation Medicine is a molecular information company dedicated to a transformation in cancer care in which treatment is informed by a deep understanding of the genomic changes that contribute to each patient's unique cancer. The company offers a full suite of comprehensive genomic profiling assays to identify the molecular alterations in a patient’s cancer and match them with relevant targeted therapies, immunotherapies and clinical trials. Foundation Medicine’s molecular information platform aims to improve day-to-day care for patients by serving the needs of clinicians, academic researchers and drug developers to help advance the science of molecular medicine in cancer. For more information, please visit us at www.FoundationMedicine.com or follow @FoundationATCG on Twitter. Community Guidelines: bit.ly/FMICommunityGuidelines
