Gxp Compliance Program Manager Jobs (NOW HIRING)

The Opportunity:

The Executive Director, GxP Quality & Compliance is a senior leadership role responsible for defining and executing the global compliance strategy across clinical development programs and commercial products. This role will ensure adherence to applicable regulatory requirements, industry standards, and company policies governing GxP activities. The role provides strategic oversight of inspection readiness, quality systems, compliance risk management, supplier oversight and compliance, and enterprise-wide GxP initiatives. In this role, you will shape enterprise quality strategy, influence executive decision-making, and build a world-class compliance organization that supports sustainable growth and operational excellence.

This position serves as a key advisor to senior leadership on global compliance policy and strategy and reports to the Vice President, Global Quality.

Key Responsibilities:

• Develop and execute the organization's global GxP Compliance strategy, ensuring alignment with corporate objectives, business priorities, and global regulatory requirements.

• Provide executive leadership for the Quality Compliance function, fostering a culture of quality, integrity, accountability, and continuous improvement across the organization.

• Ensure enterprise-wide compliance with FDA, EMA, MHRA, Health Canada, ICH, and other applicable global regulations, including cGMP, GCP, GLP, GDP, and GVP, as applicable.

• Serve as the executive lead for regulatory inspections, health authority interactions, and inspection readiness activities, ensuring the organization maintains a continuous state of readiness.

• Direct the strategy, governance, implementation, and continuous improvement of the Quality Management System (QMS), including policies, procedures, standards, and compliance processes.

• Lead enterprise compliance risk management by proactively identifying, assessing, and mitigating regulatory and quality risks while advising executive leadership on strategic compliance decisions.

• Partner collaboratively with PDM, Quality Assurance, Regulatory Affairs, Clinical Development, Life Cycle Management, and Information Technology to ensure consistent GxP compliance across all business functions.

• Establish, monitor, and communicate quality and compliance metrics, dashboards, and key performance indicators (KPIs) to executive leadership and governance committees.

• Ensure compliance with data integrity requirements, computerized system validation (CSV), electronic Quality Management Systems (eQMS), and emerging digital technologies.

• Champion operational excellence and continuous improvement initiatives that strengthen compliance, enhance efficiency, and improve inspection readiness and organizational performance.

• Provide strategic compliance oversight of supplier quality and audit programs managed by GxP Vendor Management, ensuring risk-based governance, visibility to significant findings, and alignment with enterprise compliance priorities.

• Advise GCP and GMP QA Operations on deviation, CAPA, and quality event governance, with focus on systemic risk, effectiveness of corrective actions, and escalation of significant compliance trends.

• Support organizational growth initiatives, including product launches, technology transfers, acquisitions, business integrations, commercialization, and expansion into new global markets.

Required Skills, Experience and Education:

• Advanced degree in life sciences, pharmacy, chemistry, or a related scientific discipline (PhD, MS, or equivalent preferred).

• 15+ years of progressive experience in GxP Quality and Compliance within the pharmaceutical, biotechnology, medical device, or related life sciences industry with extensive knowledge of FDA regulations, ICH Guidelines, EU GMP, and global GxP requirements.

• 8+ years of executive or senior leadership experience leading global quality and compliance organizations.

• Demonstrated success leading regulatory inspections and maintaining inspection readiness for FDA and international regulatory agencies.

• Excellent leadership, communication, strategic planning, cross-functional collaboration and people skills, with the ability to influence stakeholders at all levels.

• This role may require occasional travel (up to 15%) for audits, inspections, and meetings.

• Flexibility to work in a fast-paced, dynamic environment with evolving priorities.

Preferred Skills:

• Experience leading global GxP compliance programs across both clinical development and commercial product environments, including inspection readiness, launch readiness, and post-approval compliance oversight.

• Demonstrated success building and scaling enterprise compliance governance in a rapidly growing, highly outsourced biotechnology or oncology-focused organization.

• Experience advising executive leadership on global compliance risks, regulatory inspection strategy, quality system maturity, and enterprise-level remediation priorities.

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