Vice President, Analytical Development & Quality Control

The Opportunity:

We are seeking a strategic and execution-driven Vice President, Analytical Development & Quality Control (ADQC) to lead the vision, strategy, and execution of analytical development and QC across our growing portfolio.

Reporting to the Senior Vice President, Pharmaceutical Development & Manufacturing, this executive will build and scale a phase-appropriate, forward-looking analytical organization that enables rapid development of small molecule programs while positioning the company for late-stage development and global commercialization.

As a key member of the PDM leadership team, this role will shape analytical strategy at the enterprise level, ensuring robust control strategies, regulatory readiness, and operational excellence across internal and external networks.

Responsibilities:

Strategic & Organizational Leadership

• Define and drive the enterprise-wide analytical development and QC strategy aligned with portfolio and corporate objectives.

• Build, lead, and scale a high-performing ADQC organization to support a multi-asset oncology pipeline.

• Establish a culture of scientific excellence, accountability, and collaboration aligned with RevMed values.

• Serve as a core member of the PDM leadership team, influencing cross-functional CMC and development strategies.

Technical & Analytical Excellence

• Design and implement phase-appropriate analytical strategies, including characterization, specification setting, and control strategies.

• Oversee impurity profiling, degradant analysis, comparability, and lifecycle management of analytical methods.

• Ensure alignment of analytical approaches with clinical and regulatory needs, enabling accelerated development timelines.

• Drive innovation in analytical technologies and approaches for complex, mechanism-driven small molecules.

Quality Control & Operations

• Establish and oversee compliant, efficient QC operations with strong data integrity and digital systems.

• Ensure inspection readiness and adherence to global regulatory standards (FDA, EMA, ICH).

• Implement scalable processes to support late-stage development and commercialization.

External Network & Partnerships

• Lead the strategy and oversight of outsourced analytical development and QC activities.

• Select, qualify, and manage CDMOs and contract laboratories to ensure high performance and compliance.

• Oversee method transfer, validation, and lifecycle management across external partners.

• Proactively manage risks, timelines, and quality across the external network.

Regulatory Leadership

• Provide analytical leadership for global regulatory submissions (IND, IMPD, NDA, MAA, JNDA.

• Represent ADQC in health authority interactions and inspections as needed.

Required Skills, Experience and Education:

• PhD (preferred) or MSc in Analytical Chemistry, Pharmaceutical Sciences, or related field.

• ~18+ years of industry experience with significant leadership in analytical development and QC.

• Proven track record supporting late-stage development and global regulatory filings (IND/NDA/MAA/JNDA).

• Demonstrated success leading and scaling teams (10+ years in leadership roles preferred).

• Deep expertise in GMP, quality systems, and global regulatory expectations (FDA, EMA, ICH).

• Extensive experience managing external analytical networks (CDMOs, CTLs).

• Strong strategic thinking with the ability to make data-driven, risk-balanced decisions.

• Excellent communication and stakeholder influence at executive levels.

Preferred Skills:

• Experience in oncology or targeted therapies.

• Background in accelerated or expedited development pathways.

• Experience building analytical/QC functions in a high-growth biotech environment.

• Ability to balance speed, quality, and risk in a dynamic setting. 

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