Senior Manager, Clinical Quality Audit & Inspection Program

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed.

The Opportunity

Primary 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

Qualifications and Key Success Factors

• 10+ years of experience in clinical quality assurance and GCP compliance
• Bachelor’s degree in Life Sciences, Engineering, or a related field required; CQA certification is preferred
• 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 organizationalwritten, 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).
• The physical and mental requirements of our roles include but are not limited to regular use of a computer, devices or other office equipment, clear communication, and occasional movement. You'll need comfort with screen work, basic hand coordination, and focus. Reasonable accommodations may be made to enable individuals with disabilities to perform these functions.

Compensation & Benefits

At Praxis, we believe that taking care of our people (and their people) is important, so we provide a world class benefits package to help you thrive. This includes 99% of the premium paid for medical, dental and vision plans. We also provide company-paid life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the future? We match dollar-for-dollar up to 6% on eligible 401(k) contributions and sweeten the deal with long-term stock incentives and ESPP. We provide a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, paid holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal crew of colleagues who are smart, engaged and inspiring. We aim high, collaborate hard, and produce results. Let’s achieve the impossible together!

To round out our world-class total rewards package, we provide annualized base salary compensation in the range listed below. Final salary range may be modified commensurate with job level, education, and experience.