Associate Director, Clinical Audits (Remote)

This is where your work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today tomorrow and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together our community is driven by a culture of courage trust and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations and we hold each other accountable for delivering exceptional results.

Here you will find more than just a jobyou will find purpose and pride.

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

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 - $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.

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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

Key Skills

Program assessment,FDA Regulations,Manufacturing & Controls,Program Evaluation,budget forecast,Research Experience,Operations Management,Research & Development,Strategic Planning,Contract Management,Leadership Experience,negotiation

Employment Type : Full-Time

Experience : years

Vacancy : 1

Yearly Salary Salary : 152000 - 209000