Director, Product Quality Small Molecule
About The Position
The Director, Product Quality Small Molecule provides quality leadership for cross-functional teams in a matrix environment, driving alignment and decision-making through scientifically sound, risk-based evaluations of process and product quality data and patient-oriented strategies. The role applies in-depth quality and scientific knowledge to product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications, and in-process controls. The Director leads Product Quality Team activities and aligns quality strategy, priorities, and deliverables across the product lifecycle. The role oversees product quality risk identification, assessment, and mitigation; develops control strategies; authors and approves product-quality regulatory filings; and supports responses to health authority questions. The position also provides cross-functional guidance, assesses quality impacts of changes and events, supports technology transfers and product launches, and helps ensure inspection readiness. The Director communicates complex technical information to leadership, teams, and regulatory agencies and may act as delegate to the Senior Director, Product Quality Heads.
Responsibilities
- Provide quality leadership on cross-functional teams in a matrix environment, driving alignment and decision-making through scientifically sound, risk-based evaluation of process and product quality data and patient-oriented strategies.
- Execute and drive product strategies using quality and scientific expertise in product development, technology transfers, global regulatory filing strategies, analytical methods, stability, drug substance and drug product specifications, and in-process controls.
- Lead Product Quality Team activities to align product quality strategy, priorities, and deliverables across the product lifecycle.
- Use the product quality risk register to drive identification, assessment, and mitigation of product quality risks using a science- and risk-based approach.
- Monitor and review cross-functional process and product data to identify trends and ensure quality and compliance risks are proactively addressed and escalated as needed.
- Lead development of control strategies, including in-process controls, starting material, drug substance and drug product specifications, stability strategy, and comparability approaches.
- Author and approve regulatory filings associated with product quality and support responses to health authority questions.
- Provide cross-functional guidance to align product quality strategy across development, manufacturing, analytical, and regulatory stakeholders.
- Assess product quality impacts for changes, deviations, and events, and ensure appropriate implementation plans are developed.
- Support drug substance and drug product technology transfer and new product launches.
- Ensure inspection readiness, including PAI/PLI preparation through participation as a product expert.
- Apply science- and risk-based evaluation to complex issues and develop practical, patient-focused solutions balancing quality, regulatory expectations, and business needs.
- Communicate complex quality and technical information clearly to leadership, cross-functional teams, and regulatory agencies.
- Act as delegate to the Senior Director, Product Quality Heads, as needed.
Benefits
- Discretionary annual bonus eligibility
- Discretionary stock-based long-term incentives; eligibility may vary by role
- Paid time off
- Company-sponsored medical insurance
- Company-sponsored dental insurance
- Company-sponsored vision insurance
- Company-sponsored life insurance
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
No Education Listed
