About the Role

Responsible for developing and leading the strategy and operational plans for Clinical QA and contributing to broader Quality and organizational strategy. Provides strategic leadership for clinical quality and GCP compliance across the clinical development portfolio and establishes the long term direction, capabilities, processes, and quality systems necessary to support business objectives. Leads Clinical QA activities and teams responsible for ensuring compliance and effective quality oversight of clinical development activities. Serves as a senior Quality advisor to Clinical Development, Clinical Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other key stakeholders, providing strategic guidance on complex and emerging compliance matters. Leads the company through regulatory inspections and provides strategic oversight of clinical audits, inspection readiness, quality risk management, and the clinical Quality Management System (QMS). Establishes organizational priorities, resource plans, budgets, and performance objectives and develops talent and organizational capabilities to meet current and future business needs.

Your Contributions (Include, But Are Not Limited To)

Develops and leads multi-year strategy and operational plans for Clinical QA aligned with

Quality, R&D, and company objectives. Establishes priorities, capabilities, resources, and measures of success necessary to execute the strategy

Provides strategic leadership for GCP quality and compliance across the clinical

development portfolio and champions a strong Quality Culture throughout the organization

Serves as a senior Quality advisor and strategic partner to Clinical Development, Clinical

Operations, Biostatistics, Pharmacovigilance, Regulatory Affairs, and other functional leaders regarding complex compliance issues, emerging risks, and interpretation of global GCP regulatory requirements and expectations

Leads the development and evolution of the Clinical QA vision, goals, core capabilities,

operating model, and long-term roadmap to support evolving business, portfolio, and regulatory needs

Provides strategic leadership and oversight for regulatory inspection readiness and

regulatory inspections, including inspection readiness planning, mock inspections, pre approval inspections, responses to regulatory authorities, and risk-based management of inspection-related quality events

Directs the development, implementation, governance, and continuous improvement of the

clinical QMS, ensuring systems and processes remain effective, scalable, risk-based, and aligned with evolving global regulatory expectations and business needs

Establishes and oversees risk-based audit and compliance strategies for global clinical

investigators, contract clinical laboratories, CROs, vendors, and other external partners

Provides strategic oversight of investigator and vendor compliance and ensures significant

quality or compliance risks are appropriately escalated, assessed, and remediated through effective corrective and preventive actions

Provides Quality leadership and strategic guidance supporting investigational new drug

applications, ex-US clinical trial applications (CTAs), marketing applications, and related correspondence and interactions with global regulatory authorities.

Establishes meaningful quality metrics, trends, and risk indicators for Clinical QA and

communicates insights, emerging risks, and recommendations to senior leadership to support informed decision-making

Directs and oversees compliance activities related to drug safety and pharmacovigilance,

Phase IV studies, investigator-initiated trials, and other clinical development activities within the scope of Clinical QA

Provides strategic oversight of internal audit activities designed to assess whether policies,

procedures, systems, reporting, and conduct of investigational studies comply with applicable GCP principles, regulations, and company requirements

Anticipates changes in the global regulatory and external environment and evaluates their

potential impact on clinical development, Quality strategy, systems, and organizational capabilities. Develops proactive approaches to address emerging requirements and risks

Partners across functions to resolve complex or ambiguous quality and compliance issues

with significant business, regulatory, or portfolio impact and influences senior leaders regarding appropriate risk-based decisions

Leads, develops, and mentors Clinical QA leaders and team members. Builds

organizational capability through effective workforce planning, delegation, coaching, talent development, succession planning, and performance management

Establishes and manages Clinical QA resource plans, budgets, priorities, and external

partnerships to ensure effective execution of strategic and operational objectives

Represents Clinical QA, as appropriate, in interactions with regulatory

authorities, external partners, industry organizations, and other external stakeholders

Other duties as assigned

Requirements

RN, BSN, BS/MS, BA degree, or equivalent experience in a scientific or health care field AND

14+ years of applicable industry experience, including significant GCP leadership experience within development and/or commercial environments. Extensive GCP audit, inspection, clinical quality systems, and regulatory compliance experience required. Demonstrated experience developing and implementing GCP QA systems, processes, and procedures. Significant people leadership experience required. OR

Master’s degree in a similar field as noted above AND 12+ years of applicable experience as

noted above. OR

PhD in a similar field as noted above AND 10+ years of applicable experience as noted

above

Recognized as an internal thought leader with deep technical and business expertise and

the ability to become a company-wide advisor and emerging external industry expert

Demonstrated ability to develop and implement multi-year strategies and translate

strategic direction into executable operational plans, priorities, and measurable outcomes

Expert knowledge of own function with broad understanding of related functions and the

ability to integrate multiple disciplines and perspectives to address complex business and scientific challenges

Demonstrated ability to lead through highly complex, ambiguous, and novel situations and

develop innovative solutions with significant functional and cross-functional impact

Strong strategic mindset with the ability to anticipate emerging business, regulatory, and

industry trends and incorporate them into long-term plans and organizational priorities

Exceptional interpersonal, executive communication, and influencing skills, including the

ability to communicate effectively with senior leadership, regulatory authorities, external partners, and diverse cross-functional stakeholders

Demonstrated ability to influence significant decisions across organizational boundaries

and build alignment among stakeholders with differing priorities and perspectives

Proven leadership skills with the ability to effectively lead, develop, mentor, and motivate

leaders and professional staff to achieve strategic and operational objectives

Demonstrated ability to build high-performing teams, strengthen organizational capability,

develop talent, and establish succession and development plans for critical roles

Strong decision quality and judgment, including the ability to assess complex risks,

integrate diverse perspectives, and make timely decisions with long-term organizational implications

Demonstrated ability to establish clear accountability for outcomes and create an

environment focused on execution, continuous improvement, ethical conduct, and sustained high performance

Ability to serve as a trusted advisor and advocate for Quality while balancing compliance,

patient safety, business objectives, and organizational priorities

Expert knowledge of clinical trial-related FDA regulations, ICH Guidelines, and international

GCP regulations and guidelines

Extensive experience developing and overseeing comprehensive, risk-based audit and

compliance programs for investigator sites, CROs, clinical laboratories, vendors, and other clinical research partners supporting Phase I-IV studies

Expert knowledge of auditing principles, techniques, inspection readiness, regulatory

inspection management, quality risk management, and corrective and preventive action processes

Extensive experience interacting with regulatory authorities and leading or providing senior

Quality leadership for regulatory inspections and inspection readiness activities

Broad and deep understanding of domestic and international regulations and guidance

documents, including FDA and EMA requirements and evolving global expectations for clinical research and GCP compliance

Extensive pharmaceutical and/or biotechnology and/or medical device industry experience

with deep knowledge of quality systems and regulatory compliance requirements applicable to clinical development

Expert knowledge of GCP requirements and strong working knowledge of GLP and/or GMP

systems throughout the product lifecycle

Demonstrated ability to develop, implement, and continuously improve clinical quality

systems, processes, procedures, governance, and risk-based compliance strategies

Demonstrated ability to assess complex clinical quality and compliance risks, identify

systemic or emerging trends, and develop strategic approaches that appropriately balance regulatory requirements and business objectives

Proven ability to establish productive relationships with senior cross-functional leaders,

regulatory authorities, clinical investigators, CROs, vendors, and external partners

Demonstrated success leading and developing Clinical QA organizations and/or teams,

including developing leaders and building organizational capabilities to support evolving business needs

Expert ability to manage multiple complex workstreams and priorities in a dynamic

development environment while maintaining focus on long-term strategy and organizational outcomes