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 Praxis is hiring a diligent, detail-driven quality leader with a sharp eye for compliance risk, operational rigor, and inspection readiness to serve as Senior Manager, Clinical Quality Audit & Inspection Programs. You will own the development and management of a global GCP, GPvP, and GCLP audit and inspection program and related plan to ensure compliance risk-based sponsor oversight and monitoring in accordance with global regulations, guidance, and company policies. You'll provide leadership to, and partner with, cross-functional stakeholders to ensure inspection readiness and remediation of audit and inspection observations across clinical programs and trials, vendors, investigator sites, and critical processes. 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 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).
• 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. Company Overview 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. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members. Diversity, Equity & Inclusion Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE® to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert Praxis has recently become aware of fraudulent job recruitment postings from individuals claiming to represent Praxis. These postings seek financial information in connection with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in connection with a Praxis job opportunity, please report it to [email protected]. Praxis does not accept unsolicited submissions from recruitment agencies for open positions. We ask all recruitment agencies to refrain from contacting any Praxis employee regarding any position. All unsolicited resumes submitted by recruitment agencies to any Praxis employee in any form or method will be deemed to be the property of Praxis, and Praxis explicitly reserves the right to hire those candidate(s) without any financial obligation to the recruitment agency. Apply tot his job Apply To this Job