Senior Director – Quality Compliance and Risk Management

This is a fully remote position, open to applicants in California.

📋 Description

• Deliver senior-level leadership for compliance with quality standards, quality risk management, vendor qualification and oversight, internal and external audit programs, management of inspection readiness, data integrity, and related compliance initiatives.

• Collaborate with teams across Quality, Clinical Development and Operations, CMC, Regulatory Affairs, Pharmacovigilance, IT, Legal/Data Protection, and other functional areas.

• Engage with external CROs, CMOs, laboratories, consultants, technology providers, and other GxP vendors.

• Ensure organizational readiness for inspections through GxP gap assessments, readiness evaluations, mock inspections, document and process preparation, as well as mitigation tracking.

• Conduct and coordinate assessments of data integrity, compliance gaps, and quality risks across GxP activities.

• Oversee the GxP vendor qualification and oversight program, coordinating risk-based external audits and managing the global audit calendar.

• Develop and implement the internal quality audit program.

• Manage inspections by regulatory authorities, including planning, front-room/back-room activities, document requests, SME preparation, interactions with inspectors, responses, and follow-up actions.

• Establish and uphold quality risk management strategies for significant compliance issues.

• Provide oversight regarding quality issues related to data integrity, data breaches, and privacy incidents affecting GxP systems, records, product quality, patient safety, or regulatory adherence.

• Offer quality oversight for GxP computerized systems and the validation of those systems.

• Keep abreast of regulatory developments, trends in inspections, enforcement activities, and changing GxP expectations.

• Render senior-level quality judgment on intricate compliance and risk issues.

⛳️ Requirements

• Bachelor's degree in life science, quality, engineering, or a related field.

• A minimum of 15 years of progressively responsible experience in pharmaceutical or biotechnology Quality.

• Extensive experience across various GxP disciplines, including GMP, GCP, GLP/nonclinical, data integrity, and computerized systems.

• Significant background in Quality compliance, Quality Risk Management, inspection readiness, GxP auditing, and vendor oversight.

• Proven experience in conducting GxP gap analyses, compliance assessments, data integrity evaluations, and risk-based evaluations and mitigations.

• Experience managing regulatory authority inspections.

• Experience in developing, conducting, or overseeing risk-based internal and external GxP audit programs.

• Experience in managing risk-based vendor qualification, periodic evaluations, re-evaluations, and ongoing oversight programs.

• Ability to apply quality risk management principles to complex issues, systems, vendors, data, and business decisions.

• Strong independent quality judgment with the capacity to identify, prioritize, escalate, and address significant or systemic risks.

• Ability to swiftly assess intricate GxP issues, engage subject matter experts, and drive risk-based decisions.

• Excellent skills in organization, problem-solving, prioritization, and time management.

• Strong written and verbal communication skills complemented by a collaborative, team-oriented approach.

• Ability to excel in a fast-paced, dynamic environment while remaining adaptable to change and ambiguity.

• Flexible, proactive, and hands-on mindset.

• Preferred: experience in small, rapidly growing, or startup pharmaceutical or biotechnology firms.

• Preferred: experience supporting late-stage clinical development, regulatory submissions, and transition to commercial operations.

• Preferred: experience in evaluating in-licensed programs or data packages.

• Preferred: experience in computerized system validation, IT Quality, data integrity, regulatory intelligence, and comprehensive Quality leadership.

🏝️ Benefits

• Competitive total rewards package.

• Eligibility for annual bonuses.

• Equity eligibility.

• Comprehensive benefits offerings.

• Commitment to equal opportunity and inclusion.

• Federal E-Verify employment authorization verification for new hires.