Associate Director, Clinical Quality Assurance

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. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s 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 AD, Clinical Quality Assurance (CQA) is responsible for leading activities that result in being an organization that is clinical trial “Audit Ready”.  The primary responsibilities include: Leading the Clinical Quality Assurance Program, performing vendor qualification and management activities, accountability for clinical trial policies and procedures, investigation of clinical research quality concerns, and providing interpretation and application of current and upcoming regulations in the industry.  This position reports to the VP, WWM Strategy, Governance, and Operations with a dotted line to VP, Quality Compliance

What you'll be doing:

• Develops and executes risk-based quality assurance strategies to support clinical operations activities, which include assessment / audit planning, conduct, documentation and follow up of planned activities

• Maintains knowledge of FDA and other regulatory agencies’ (e.g., European agencies) activities, regulations and guidelines relevant to Clinical Affairs

• Monitors relevant agency compliance rulings and communications

• Provides expertise and guidance to collaborating departments in interpreting and implementing government and agency guidelines to assure GCP compliance

• Leads the supplier/vendor qualification and compliance oversight process related to Clinical research

• In partnership with Quality, lkeads the development, implementation, and execution of GCP compliance auditing programs to ensure the fulfillment of regulatory requirements

• Reviews and monitors Clinical research related Corrective Action/ Prevention Action Plans identified internally and/or externally and assist in root cause analysis and formulating responses

• Independently supports regulatory inspections of Sponsor, GCP sites and GC P vendors

• Supports the Quality Planning Process and risk profiling activity & mitigation approaches during clinical study life-cycle

• Supports the management of clinical quality systems & continuous improvement

• Interacts and develops relationships with clinical research vendors’ quality leaders through audits, project teams, and established one-on-one relationships

• Writes GxP Quality SOPs in support of the Clinical Quality Systems

• Ensures compliance with corporate policies and procedures as well as US or other applicable healthcare authorities’ laws and regulations through ongoing assessments during the conduct of clinical studies

• Identifies additional capacity needs for clinical research audit activity, assist in sourcing, and train incumbents on internal SOP’s related to the clinical trial audit program

• Development and maintenance of written internal procedures for clinical assessments and associated templates

• Leads the production of training material and training sessions regarding compliance to clinical research policies, procedures, standards and regulations

• Participation in external committees (e.g., AdvaMed) as requested

• Manage a team of 1-4 employees who are responsible for supporting the clinical quality assurance program

What you'll bring:

• Bachelor’s Degree required, preferably in the life sciences

• Minimum ten years’ experience working within a regulated bio-medical industry, verifying compliance to global regulations

• People management experience of 1+ years

• Clinical quality assurance medical device and/or pharmaceutical experience, with significant medical device experience in clinical research highly preferred

• Certified auditor is a preference 

• Advanced knowledge and understanding of clinical development programs and clinical trial processes as well as quality management systems and quality control tools

• Advanced knowledge of and experience of with all regulations, and relevant standards (e.g., FDA, ISO, MDR, IVDR GDPR)

• Knowledge of and experience with OUS country related regulations

• Knowledge of processes related to Clinical Data Management and Biostatistics functions

• Experience partnering with Regulatory Affairs and/or Quality department.

• ASQ certification, IRCA or other relevant auditor certification a plus

• Effective communication skills both verbal and written

• Ability to work independently with minimal supervision and accountable for managing multiple clinical quality study activities concurrently

• Demonstrates leadership abilities

• Establishes rapport and collaborates with other (internal and external) team members; builds constructive and effective relationships

• Anticipates problems, issues, and delays; proactively looks to minimize the impact of identified compliance issues

• Multi-disciplinary knowledge across functional areas

• Up to 20% travel

• Remote

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 $152,000 to $209,000 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 employees. For 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.

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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.

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