Impress employers and recruiters.
Choose from hundreds of resume examples.

Impress employers and recruiters.
Choose from hundreds of resume examples.

Target Resume Now

About the Role

This leadership role establishes and manages a risk-based quality strategy for clinical development and pharmacovigilance activities, ensuring participant safety, data integrity, and global regulatory compliance in a fast-paced biotech environment.

Responsibilities

• Establish and manage a risk-based audit program across clinical development and pharmacovigilance activities.
• Lead the planning, scheduling, execution, and follow-up of investigator sites, CRO, clinical vendors, safety vendors, and internal audits across U.S. and ex-U.S. geographies.
• Oversee audits and assessments of clinical and pharmacovigilance documentation, systems, and processes, with a focus on pivotal-trial inspection readiness.
• Develop, maintain, and continuously improve quality policies, standard operating procedures, and associated documents supporting clinical and pharmacovigilance operations.
• Oversee quality events, deviations, CAPAs, change controls, and training processes across clinical and pharmacovigilance functions.
• Support quality governance processes through the development, monitoring, and reporting of quality metrics, trends, and key performance indicators.
• Lead company-wide inspection readiness activities for GCP and pharmacovigilance inspections by global Health Authorities.
• Prepare and support internal teams, sponsors, and/or clinical sites during inspections and regulatory interactions.
• Coordinate, author, and oversee responses, corrective actions, and remediation plans for inspection and audit findings.
• Serve as a primary quality and compliance resource for clinical and pharmacovigilance functional areas.
• Provide quality oversight and review of regulatory submissions and operational processes to support compliant clinical development and pharmacovigilance activities.

Requirements

• Bachelor’s degree in a scientific, medical, or related field required; an advanced degree or quality certification is preferred.
• Minimum of 10 years of experience in the pharmaceutical or biotechnology industry, including at least 5 years of direct quality experience supporting clinical development and/or pharmacovigilance.
• Small or mid-size biotech experience and direct support of Phase 2/3 pivotal programs strongly preferred.
• Strong working knowledge of ICH-GCP (E6(R2/R3)), ICH E8(R1), EU GVP modules, FDA 21 CFR Parts 11, 50, 54, 56, 312, and 314, and applicable global clinical trial and safety regulations.
• Demonstrated experience supporting audits, inspections, and quality systems across clinical and pharmacovigilance functions.
• Experience providing quality oversight of key clinical and pharmacovigilance processes, including investigator site, CRO, and vendor oversight.
• Working knowledge of quality system requirements, including deviations, Quality Investigations, CAPAs, change controls, training, clinical complaints, and procedural documentation.
• Experience developing, monitoring, and communicating quality metrics, dashboards, and governance reports.
• Experience supporting or auditing documentation and systems relevant to clinical development and pharmacovigilance, including Trial Master Files and safety records.
• Willingness to travel domestically and internationally up to 30% as needed.

Skills

• Risk-based quality strategy
• GCP and GVP compliance
• Inspection readiness
• Quality governance
• Metrics and continuous improvement
• Strategic quality partnership
• Audit program management
• ICH-GCP
• ICH E8(R1)
• EU GVP modules
• FDA regulations
• Global clinical trial regulations
• Safety regulations
• Quality system requirements
• Quality metrics reporting
• Documentation and system auditing

Location

• U.S.
• ex-U.S.

Work Type

• Full-time
• Onsite

Experience Level

• Director
• 10+ years of experience
• 5+ years of direct quality experience

Education Level

• Bachelor’s degree in a scientific, medical, or related field
• Advanced degree or quality certification preferred

Salary/Compensations

• $200K – $215K

About the Company

• The Values We Hope You Share: Purpose Driven, Transparent, Bold, Intelligent, Unified.
• Our values underpin the employee experience at LB Pharmaceuticals. They are the character and personality of the company demonstrated through how we communicate, support one another, spend our time, make decisions, and celebrate collectively.