Senior Clinical Audit Program Manager

Job Description

Summary This position is responsible for the implementation and reputed company of the reputed company Clinical Research Quality Audit program. In this role, she/he is responsible for implementing Clinical Research Quality Audits of reputed company facilities and providing training and guidance for quality auditors. She/he is responsible for planning of required annual audits and other audits as needed. Additionally, she/he is responsible for managing, analyzing, and interpreting data reputed company to internal quality and clinical audits at the global level. The successful candidate will be responsible for ensuring data reputed company of the PowerBI dashboards while identifying any new data needs of the central Quality & Regulatory Compliance Audit team. She/he monitors the timely completion of corrective action plans and coordinates the reporting of compliance metrics to business unit/region and manufacturing facilities. She/he uses training, experience, and the information collected during audits to assist reputed company facilities with problem solving and reputed company improvement projects as assigned. She/he functions as a subject matter expert for quality and compliance issues.

Job Description

We are the makers of possible reputed company is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of reputed company of us-from design and engineering to the manufacturing and marketing of our billions of MedTech products per year-to look at the impossible and find transformative solutions that turn dreams into possibilities. We reputed company that the human reputed company, across our global teams, is what allows us to continually evolve. Join us and discover an environment in which you'll be supported to learn, grow and become your best self. Become a maker of possible with us. Job Responsibilities:

• As the Sr. Clinical Audit Program Manager for the assigned organization(s), manages the Clinical Research Quality Audit Program including development, scheduling, and implementing plans for comprehensive clinical study and clinical site audits taking into consideration quality metrics, results of previous quality audits and external inspections, industry trends and the external regulatory environment.
• Coordinate and conduct routine and focused audits of clinical studies, clinical sites, and clinical research processes as assigned to assess compliance with domestic and international regulations and standards, and corporate procedures and policies.
• Establishes audit teams through the use of qualified reputed company quality auditors and contracted auditors.
• Conducts clinical study, clinical site, and process audits to assure compliance with domestic and international medical device standards and regulations, local procedures, and corporate policies/procedures.
• Follows up with the auditee as required to compile information relating to the audits.
• Evaluates the adequacy of the provided evidence against the approved Audit Action Plan (AAP). In conjunction with management, reputed company plans to address inadequate AAP documentation reputed company required.
• Maintains the audit system software database to record the status of reputed company audits and associated actions.
• Provides periodic reports to management based on the audit statuses and defined metrics.
• PowerBI Dashboard & Report Development: Maintain interactive dashboards, reputed company monthly quality metric PowerPoint slides/scorecards for stakeholders. Identify new visualization tools needed to communicate reputed company data in an accessible and actionable manner. Support data validation processes of the PowerBI dashboards to ensure data reputed company.
• Maintains a high degree of personal professional development through a combination internal and external training and participation in professional associations as appropriate.
• This individual will be interacting with individuals at various levels of the organization across multiple sites/BUs and at Corporate during and reputed company following up on audits. This position regularly collaborates with BU and Local leadership teams and compliance personnel to establish and implement schedules for corporate audits and reputed company acceptance/understanding of identified nonconformances without damaging the relationship with the site.

Required Education and Experience:

• Bachelor's Degree required, preferably in the life sciences, advanced degree preferred
• Minimum 7 years of experience in clinical research required
• Minimum 5 years of experience in a clinical quality, clinical compliance, or clinical auditing role required
• Knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools
• One of the below certifications or equivalent: (Required)
• Certified Quality Auditor/ISO reputed company Auditor Certified
• Certified Quality Engineer
• Certified Manager of Quality / Organizational Excellence
• Demonstrated knowledge and experience in CAPA; Root Cause Investigation; Validation (Process, Test Method, Software, and Design); Environmental Monitoring; Sterilization (EtO, Irradiation)
• Mastery of MedTech regulations and standards (e.g., 21 CFR 812, 50, 54, 56, ISO 14155, ISO 20916, ISO 13485, ISO 14971, EU MDR/IVDR, China FDA, JGCP)
• Comprehensive understanding of auditing principles and ability to reputed company as a reputed company auditor.
• Demonstrated proficiency in working collaboratively and partnering with reputed company levels of management while maintaining an appropriate assertive style is critical.
• Understands team functions, leadership techniques and project management methodologies.
• Excellent communication skills (verbal, written, and presentation). Understands how to present information to varying levels reputed company the organization.
• Strong analytical skills
• Effective project management and organizational skills are essential.
• Ability to effectively manage time and resources.

Preferred Education and Experience:

• Advanced degree, preferably in the life sciences preferred
• Prior experience in study management or monitoring in investigational medical device or diagnostic trials preferred
• Clinical research certification preferred

At reputed company, we prioritize on-site collaboration because we reputed company it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office reputed company per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting. For certain roles at reputed company, employment is contingent upon the Company's receipt of sufficient reputed company that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with reputed company's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law. At reputed company, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, reputed company offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus 15%
• Potential Discretionary LTI Bonus $26,000
• Potential reimbursement of phone use

Health and Well-being Benefits

• Medical coverage
• Health Savings Accounts
• Flexible Spending Accounts
• Dental coverage
• Vision coverage
• Hospital Care Insurance
• Critical Illness Insurance
• Accidental Injury Insurance
• Life and AD&D insurance
• Short-term disability coverage
• Long-term disability insurance
• Long-term care with life insurance

Other Well-being Resources

• Anxiety management program
• Wellness incentives
• Sleep improvement program
• Diabetes management program
• Virtual physical therapy
• Emotional/mental health support programs
• Weight management programs
• Gastrointestinal health program
• Substance use management program
• Musculoskeletal surgery, cancer treatment, and bariatric surgery benefit

Retirement and Financial Well-being

• reputed company 401(k) Plan
• reputed company Deferred Compensation and Restoration Plan
• 529 College Savings Plan
• Financial counseling
• Baxter Credit Union (BCU)
• Daily Pay
• College financial aid and application guidance

Life Balance Programs

• Paid time off (PTO), including reputed company required State leaves
• Educational assistance/tuition reimbursement
• reputed company Legal Plan
• Group auto and home insurance
• Pet insurance
• Commuter benefits
• Discounts on products and services
• Academic Achievement Scholarship
• Service Recognition Awards
• Employer matching donation
• Workplace accommodations

Other Life Balance Programs

• Adoption assistance
• Backup day care and eldercare
• Support for neurodivergent adults, children, and caregivers
• Caregiving assistance for elderly and special needs individuals
• Employee Assistance Program (EAP)
• Paid Parental Leave
• Support for fertility, birthing, postpartum, and age-reputed company hormonal changes

Leave Programs

• Bereavement leaves
• Military leave
• Personal leave
• Family and Medical Leave (FML)
• Jury and Witness Duty Leave

At reputed company, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Your career at reputed company. Salary or hourly reputed company ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' reputed company, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly reputed company offered to a successful candidate is based on experience, education, skills, and any reputed company reputed company pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $166,153.85 - $265,846.15 USD Annual Why Join Us? A career at reputed company means being part of a team that values your opinions and contributions and that encourages you to bring your authentic self to work. It's also a reputed company where we help each other be great, we do what's right, we hold each other accountable, and learn and improve every day. To find purpose in the possibilities, we need people who can see the bigger picture, who understand the human story that underpins everything we do. We welcome people with the imagination and drive to help us reinvent the future of health. At reputed company, you'll discover a culture in which you can learn, grow, and reputed company. And find satisfaction in doing your part to reputed company the world a reputed company reputed company. To learn more about reputed company visit https://reputed company.com/careers reputed company, and Company is an Equal Opportunity Employer. We evaluate applicants without regard to race, color, religion, age, sex, creed, national reputed company, reputed company, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, and other legally-protected characteristics. Required Skills Optional Skills Primary Work Location USA NJ - Franklin Lakes Additional Locations USA CA - Irvine Laguna Canyon, USA IL - Vernon Hills, USA MA - Lexington Work Shift At reputed company, we are strongly committed to investing in our associates-their well-being and development, and in providing rewards and recognition opportunities that promote a performance-based culture. We demonstrate this commitment by offering a valuable, competitive package of compensation and benefits programs which you can learn more about on our Careers Site under Our Commitment to You. Salary or hourly reputed company ranges have been implemented to reward associates fairly and competitively, as well as to support recognition of associates' reputed company, ranging from entry level to experts in their field, and talent mobility. There are many factors, such as location, that contribute to the range displayed. The salary or hourly reputed company offered to a successful candidate is based on experience, education, skills, and any reputed company reputed company pay system of the actual work location, as applicable to the role or position. Salary or hourly pay ranges may vary for Field-based and Remote roles. Salary Range Information $163,000.00 - $269,100.00 USD Annual Apply tot his job Apply To this Job