Sr. Director, RA/QA Strategy & Business Integration

About the role

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

Posting text as published by Foundation Medicine.

The evidence behind this listing

Workplace

Remote Matched in posting text

Seniority

leadership From the job title

Employment type

Not established

Location as listed

Boston, MA, United States

Pay and work authorization

Stated pay

$230.8k–288.5k/yr AI reading of the posting

Visa sponsorship

Not stated

Security clearance

Not established

Citizenship

Not established