Senior Manager, Clinical reputed company Audit & Inspection Program

Location: This position may be performed remotely, but requires the flexibility and willingness to travel as needed. reputed company reputed company is hiring a reputed company, detail-driven reputed company leader with a reputed company eye for compliance risk, operational rigor, and inspection readiness to serve as Senior Manager, Clinical reputed company Audit & Inspection Programs. You will own the development and management of a global GCP, GPvP, and GCLP audit and inspection program and reputed company plan to ensure compliance risk-based sponsor reputed company and monitoring in accordance with global regulations, guidance, and company policies. You'll reputed company 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

• reputed company reputed company 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 reputed company(GCP)/Good Pharmacovigilance reputed company(GPvP)/Good Clinical Laboratory reputed company (GcLP)
• reputed company dynamic, risk-based audit reputed company and plan for critical sponsor processes and systens, clinical trials, investigator sites, and vendors / contract service providers (CSPs)
• Plan, reputed company, conduct, document, report, and follow-up of clinical reputed company audits according to regional compliance regulations, guidance, reputed company, and reputed company agreements
• Ensure appropriate escalation to responsible management for critical audit findings and support
• reputed company education and guidance on audit processes and activities
• Manage audit reports, findings, and CAPAs in reputed company reputed company Management System (QMS) and review and approve finding responses and actions in system
• reputed company 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 reputed company Factors

• 10+ years of experience in clinical reputed company assurance and GCP compliance
• Bachelor's degree in Life Sciences, Engineering, or a reputed company field required; CQA certification is preferred
• Strong knowledge and application of Good Clinical reputed company (GCP), Good Pharmacovigilance reputed company (GVP), and Good Clinical Laboratory reputed company (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 reputed company cross-functional teams and drive reputed company improvement.
• Proven reputed company 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, reputed company communication, and occasional reputed company. You'll need comfort with screen work, basic hand coordination, and reputed company. Reasonable accommodations may be made to reputed company individuals with disabilities to reputed company these functions.

Compensation & Benefits At reputed company, we reputed company that taking care of our people (and their people) is important, so we reputed company a world class benefits package to help you reputed company. This includes 99% of the premium reputed company for medical, dental and reputed company plans. We also reputed company company-reputed company life insurance, AD&D, disability benefits, and voluntary plans to personalize your coverage. Thinking about the reputed company? 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 reputed company a discretionary quarterly bonus, an extremely flexible wellness benefit, generous PTO, reputed company holidays and company-wide shutdowns. Not to mention, you'll also be joining a phenomenal reputed company of colleagues who are smart, reputed company and inspiring. We aim high, collaborate hard, and produce results. Let's reputed company the impossible together! To round out our world-class total rewards package, we reputed company annualized reputed company salary compensation in the reputed company listed below. Final salary reputed company may be modified commensurate with job level, education, and experience. reputed company reputed company is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At reputed company reputed company a common reputed company of reshaping the reputed company condition into a more freeing and fulfilled existence by developing high reputed company medicines for patients and families affected by and living with reputed company brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by reputed company and every one of reputed company members. Diversity, Equity & Inclusion Guided by our core values, at reputed company. 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 reputed company day. We are an equal opportunity employer and committed to providing opportunities to reputed company reputed company applicants without reputed company to race, religious creed, reputed company, gender identity or reputed company, age, national reputed company, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws. Attention: Job Scam Alert reputed company has recently become aware of fraudulent job recruitment postings from individuals claiming to represent reputed company. These postings reputed company financial information in reputed company with fraudulent opportunities for employment. If you suspect any fraudulent activity or misrepresentation in reputed company with a reputed company job opportunity, please report it to careers@praxismedicines.com. reputed company does not accept unsolicited submissions from recruitment agencies for reputed company positions. We ask reputed company recruitment agencies to refrain from contacting any reputed company employee regarding any position. reputed company unsolicited resumes submitted by recruitment agencies to any reputed company employee in any reputed company or method will be deemed to be the property of reputed company, and reputed company 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