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Praxis Precision Medicines, Inc. · 2 weeks ago

Senior Manager, Clinical Quality Audit & Inspection Program

United States

Full-time

Remote

Senior Level, Lead/Staff

$120K/yr - $145K/yr

10+ years exp

Praxis Precision Medicines is a clinical-stage biopharmaceutical company focused on developing therapies for central nervous system disorders. They are seeking a Senior Manager for Clinical Quality Audit & Inspection Programs to lead the development and management of a global audit and inspection program, ensuring compliance with regulations and facilitating inspection readiness across clinical programs and trials.

Alternative MedicineBiotechnologyHealth CareMedicalPrecision Medicine

Comp. & Benefits

Responsibilities

Develop standard operating procedures, work instructions, forms, and templates to ensure a fit-for-purpose clinical auditing and inspection management program to ensure compliance with Good Clinical Practice(GCP)/Good Pharmacovigilance Practice(GPvP)/Good Clinical Laboratory Practice (GcLP)

Develop dynamic, risk-based audit strategy and plan for critical sponsor processes and systens, clinical trials, investigator sites, and vendors / contract service providers (CSPs)

Plan, lead, conduct, document, report, and follow-up of clinical quality audits according to regional compliance regulations, guidance, contracts, and quality agreements

Ensure appropriate escalation to responsible management for critical audit findings and support

Provide education and guidance on audit processes and activities

Manage audit reports, findings, and CAPAs in Veeva Quality Management System (QMS) and review and approve finding responses and actions in system

Develop and monitor audit finding response and CAPA timeliness performance metrics and present trends and improvement plans to senior management

Partner with departments across organizations to ensure consistent implementation and execution of audit program

Work independently with respect to decision making and problem solving

Qualification

Clinical Quality AssuranceGCP ComplianceAudit ManagementCQA CertificationVendor AuditsInspection ReadinessCommunication SkillsCritical ThinkingCross-Functional Leadership

Required

10+ years of experience in clinical quality assurance and GCP compliance

Bachelor's degree in Life Sciences, Engineering, or a related field required

Strong knowledge and application of Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), and Good Clinical Laboratory Practice (GCLP) is required

Ability to travel up to 40%-60% of time

Experience conducting audits of vendors and investigative sites

Excellent organizational written, verbal, and presentation communication skills which must include audit report writing, presentation and defense of findings

Experience in inspection readiness and preparation

Experience hosting and interacting with regulatory authorities

Critical thinking and prioritization

Experience managing and being accountable for vendors / contractors and their deliverables

Proven ability to lead cross-functional teams and drive continuous improvement

Proven track record and experience in supporting regulatory inspections (FDA, EMA)

Preferred

CQA certification is preferred

Benefits

99% of the premium paid for medical, dental and vision plans.

Company-paid life insurance

AD&D

Disability benefits

Voluntary plans to personalize your coverage

401(k) contributions matched dollar-for-dollar up to 6%

Long-term stock incentives

ESPP

Discretionary quarterly bonus

Flexible wellness benefit

Generous PTO

Paid holidays

Company-wide shutdowns

Company

Praxis Precision Medicines, Inc.

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance.

Founded in 2015

Cambridge, Massachusetts, USA

51-200 employees