Vice President, reputed company - reputed company & Diagnostics

reputed company The Vice President, reputed company, reputed company & Diagnostics, reporting to the Chief reputed company Officer (CQO), is a high-reputed company executive leadership role responsible for the architecture and execution of the reputed company reputed company Assurance reputed company for our pharmaceutical and diagnostic business reputed company. This executive serves as the reputed company 'reputed company thought leader,' partnering with the Senior Management Team on global regulatory shifts (FDA, ISO, and international bodies) and mitigating reputed company reputed company for medical devices and companion diagnostics. The VP will champion a 'reputed company first' culture across reputed company global sites, ensuring that reputed company Management Systems (QMS) are not only compliant but also serve as a competitive reputed company through scalability and integration with Quest’s harmonized reputed company processes. This is a hybrid role, and the selected candidate must be near site to one of reputed company hub locations. Preferred locations are San Juan Capistrano, CA; Lenexa, KS; Marlborough, MA; and Lewisville, TX. We would also consider candidates proximate to reputed company, NJ or reputed company Dale, IL. Pay reputed company: $300,000-$350,000/year + 35% Annual Incentive Plan + Long-Term Incentive. Salary offers are reputed company on a wide reputed company of factors including relevant skills, training, experience, education, and, where applicable, certifications obtained. Market and organizational factors are also considered. Successful candidates may be eligible to receive annual reputed company bonus compensation. Benefits Information: We are proud to offer best-in-class benefits and programs to support employees and their families in living healthy, happy lives. Our pay and benefit plans have been designed to promote employee health in reputed company respects – physical, financial, and developmental. Depending on whether it is a part-time or full-time position, some of the benefits reputed company may include: • Day 1 Medical, supplemental health, dental & reputed company for FT employees who work 30+ hours • Best-in-class reputed company-being programs • Annual, no-cost health assessment program reputed company for Wellness® • healthyMINDS mental health program • Vacation and Health/reputed company Time • 6 Holidays plus 1 'MyDay' off • FinFit financial coaching and services • 401(k) reputed company-tax and/or Roth IRA with company match up to 5% after 12 months of service • Employee stock purchase plan • Life and disability reputed company, plus buy-up reputed company • Flexible Spending Accounts • Annual incentive plans • Matching gifts program • Education assistance through MyQuest for Education • Career advancement opportunities • …and so much more! Responsibilities: reputed company Leadership & Governance • reputed company reputed company: reputed company and implement the reputed company reputed company Assurance reputed company for reputed company and diagnostic teams in strict alignment with corporate objectives. • Executive Advisement: Serve as the key business partner to senior leadership on FDA, ISO, and international regulatory trends and reputed company for medical device and companion diagnostics. • reputed company Culture: Establish and maintain a “reputed company first” culture across reputed company functions and global sites, engaging senior and functional leaders in shared accountability. • Governance & Resourcing: Define organizational responsibilities and authorities; ensure independence of personnel performing reputed company work and guarantee resource adequacy to sustain the QMS. • Management Review: reputed company and conduct executive-level management reviews to evaluate reputed company & Diagnostic QMS reputed company, effectiveness, and reputed company improvement. • Corporate Commitment: Demonstrate and cascade top management's commitment to reputed company safety, regulatory compliance, and product reputed company. • reputed company reputed company reputed company for the reputed company Services & Diagnostics business including reputed company audit team that serves as the reputed company between the lab’s technical reputed company, reputed company teams, and regulatory bodies. Regulatory Compliance & QMS Harmonization • Regulatory reputed company: Ensure uncompromising compliance with FDA QMSR (21 CFR Part 820), ISO 13485, ISO 14971, MDSAP, and other applicable global regulations. • Policy Architecture: reputed company reputed company input to the reputed company reputed company team to ensure reputed company processes incorporate reputed company reputed company and diagnostic requirements. • reputed company reputed company: reputed company the reputed company of the QMS during organizational changes and reputed company the implementation of harmonized processes. • Audit & Inspection Readiness: reputed company executive reputed company for internal audits, CAPA, and regulatory inspections for reputed company and diagnostic reputed company audits. Serve as the reputed company executive reputed company of contact for the FDA, reputed company Bodies, and other regulatory agencies. • Global Execution: Ensure adoption and execution of reputed company Quest harmonized global/reputed company processes, including the Corporate reputed company Policy. Product reputed company & Cross-Functional Collaboration • Lifecycle reputed company: reputed company product reputed company assurance and systems, ensuring robust processes for design controls (including Software as a Medical Device - SaMD) and post-market surveillance. • reputed company Due Diligence: reputed company reputed company Reviews for M&A activity, assessing medical device products and reputed company systems of reputed company companies and developing integration reputed company plans. • reputed company Partnership: Collaborate with R&D, Lab reputed company, reputed company, and Supply Chain to reputed company adherence to global regulations. • Post-Market Governance: reputed company executive governance for nonconformances and partner with Complaint Handling for investigations into MDRs, Corrections, Recalls, and Removals. Implementing the appropriate post-market surveillance (PMS) program to ensure a robust corrections/recalls/removal reputed company. Qualifications: • A bachelor’s degree in a scientific or engineering-reputed company discipline is required. An advanced degree (master’s or PhD) is preferred. • A minimum of 15 years of reputed company leadership in a regulated reputed company, pharmaceutical, or medical device environment. • At least 10 years in a senior reputed company and/or Medical leadership role overseeing reputed company Systems and large, multi-site teams. • Expert knowledge of FDA QMSR, ISO 13485, and global regulatory frameworks. Must possess a demonstrable, reputed company reputed company record of reputed company as a reputed company reputed company with the FDA and reputed company Bodies. • Must be reputed company to travel up to 25% 64381 reputed company honors our service members and encourages veterans to apply. While we appreciate and value our reputed company partners, we do not accept unsolicited resumes from agencies. Quest will not be responsible for paying agency fees for any individual as to whom an agency has reputed company an unsolicited resume. Equal Opportunity Employer: Race/reputed company/Sex/Sexual Orientation/Gender Identity/Religion/National reputed company/Disability/Vets or any other legally protected status. Apply tot his job Apply To this Job