Associate Director, Clinical Audits
Associate Director, Clinical Audits
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$ 152000 - 209000
1 Vacancy
Job Description
This is where you save and sustain lives
At Baxter we are deeply connected by our mission. No matter your role at Baxter your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.
Baxters products and therapies are found in almost every hospital worldwide in clinics and in the home. For over 85 years we have pioneered significant medical innovations that transform healthcare.
Together we create a place where we are happy successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.
Your role at Baxter
The Associate Director Clinical Audits is responsible for leading the Clinical Audit Program collaborating with clinical operations suppliers/vendors and Baxters functions/businesses. Grow clinical auditing capability utilizing expertise knowledge and experience of best-practice methodologies and practices in industry working closely with global quality compliance partners to ensure a robust Clinical Audit plan and strategy is in place.
What youll be doing
- Develop and maintain the annual risk based Clinical Audit schedule following global Audit Program and external requirements.
- Lead the preparation of conduct and reporting of Clinical Audits including clinical investigator sites clinical research organizations and internal processes/systems. Present and report Audit results concisely and logically both verbally and in writing to senior global quality compliance leadership.
- Review Clinical Audit observation responses and ensure Corrective and Preventive Action (CAPA) plans adequately address observations root causes and effectiveness checks.
- Maintain responsibility for and oversight of Clinical Audits conducted by contractors when applicable. This includes identifying suitable Clinical Audit consultants working with Procurement to establish contracts and providing relevant training in accordance with company procedures.
- Interacts and develops relationships with clinical research vendors quality leaders through audits project teams and establish one-on-one relationships.
- Subject Matter Expert/Point of Contact to provide expertise and knowledge to less experienced Auditors business partners and company entities on clinical processes. Provide clinical compliance expertise including supporting the generation of clinical Audit metrics creation and revision of SOPs.
- Participate in external inspections in core and supporting roles assisting with the preparation and delivery of appropriate training materials advising and contributing to auditee coaching.
- Identify potential issues and risks with impact on clinical trials or processes and ensure communication.
What youll bring
- A Bachelors degree in life science or engineering discipline is required; an advanced degree is preferred.
- Minimum 10 years experience working in pharmaceutical and/or medical device industries with 5 of these years as a Lead Auditor.
- 2 years experience with Regulatory Inspections Management (e.g. MHRA FDA EU inspections)
- 1 -5 years program and people management experience working in a matrix organization.
- Demonstrated ability to work as a leader with strong communication and relationship building skills.
- ASQ certification IRCA or other relevant auditor certification a plus.
- Advanced knowledge of and experience with clinical regulations and relevant standards (e.g. FDA ISO ICH EMA MDR IVDR GDPR) with practical application and execution of GCP requirements.
- Clinical Quality assurance medical device and/or pharmaceutical experience with significant medical device experience in clinical research highly preferred.
- Advanced knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools.
- Knowledge of processes related to Clinical Data Management and Biostatistics functions.
- Ability to collaborate and engage with all leadership levels through written and verbal communication.
- Ability to travel up to 50% of the time and accommodate time zone differences in case of remote audits.
We understand compensation is an important factor as you consider the next step in your career. At Baxter we are committed to equitable pay for all employees and we strive to be more transparent with our pay practices. The estimated base salary for this position is $152000 to $209000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than of the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on upon location skills and expertise experience and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this our pay philosophy and available benefits please speak to the recruiter if you decide to apply and are selected for an interview.
Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.
Advanced Molding and Extrusion techniques (Learning / Doing (1)) Automation reliability & smart manufacturing (Managing / Facilitating (3)) Critical Systems (Learning / Doing (1)) Digitalization & Systems Engineering (Managing / Facilitating (3)) Operational Quality Assurance (Leading / Driving (4))US Benefits at Baxter (except for Puerto Rico)
This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident short-term and long-term disability and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount and the 401(k) Retirement Savings Plan (RSP) with options for employee contributions and company matching. We also offer Flexible Spending Accounts educational assistance programs and time-off benefits such as paid holidays paid time off ranging from 20 to 35 days based on length of service family and medical leaves of absence and paid parental leave. Additional benefits include commuting benefits the Employee Discount Program the Employee Assistance Program (EAP) and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our additional information regarding Baxter US Benefits please speak with your recruiter or visit our Benefits site: Benefits Baxter
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race color religion gender national origin age sexual orientation gender identity or expression protected veteran status disability/handicap status or any other legally protected characteristic.
Know Your Rights: Workplace Discrimination is Illegal
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If because of a medical condition or disability you need a reasonable accommodation for any part of the application or interview process please click on the link here and let us know the nature of your request along with your contact information.
Recruitment Fraud Notice
Baxter has discovered incidents of employment scams where fraudulent parties pose as Baxter employees recruiters or other agents and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself review our Recruitment Fraud Notice.
Required Experience:
Director
Employment Type
Full-Time
