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. 

This role acts as lead pharmacovigilance (PV) auditor responsible for management and conduct of internal audits of Baxter´s global/local pharmacovigilance system for drugs/biologics and of partners with PV responsibilities (e.g., suppliers/vendors, co-licensing partners, distributors) to provide assurance that operational activities are conducted in compliance with applicable PV regulations, guidelines and the company’s policies and standards protecting patient safety. 

The Senior PV Auditor will oversee and actively manage and maintain the company's internal PV audit program, collaborating with leads of teams in Global Patient Safety (GPS) and Baxter’s functions/businesses.

This person will grow the PV auditing capability within Quality Assurance, utilizing expertise, knowledge and experience of best-practice methodologies and practices in industry, working closely with GPS and Quality Audit Service management to ensure a robust audit plan and strategy is in place.

**This position is remote, can be anywhere in the United States**

Essential Duties and Responsibilities. 

• To succeed in this role, the candidate should have extensive experience within the drug safety/PV and auditing. This role can be home-based but will require travel for audits. Travel may also be required for inspection support.
• Developing and maintaining the PV high-level audit strategy (3-5 year audit plan).
• Developing the annual audit schedule for PV audits based on annual risk assessments and PV audit strategy plan.
• Leading, planning, conducting PV audits, and reporting out of both routine and for-cause/ad hoc PV audits in accordance with the approved schedule.
• Delivering PV audit reports and reviewing. approving proposed preventive and corrective action (CAPA) plans in accordance with internal timelines.
• Maintaining responsibility for and oversight of audits conducted by PV contractors, when applicable. This includes identifying suitable PV audit consultants, working with Procurement to establish contracts and providing relevant training in accordance with company procedures.
• Participating in PV inspections in core and supporting roles, assisting with the preparation and delivery of appropriate training materials, advising and contributing to interviewee coaching.
• Contribute to quality standards of internal cross-functional processes, e.g., involving GPS, Regulatory Affairs, Worldwide Medical and/or Quality activities that apply throughout the product lifecycle.
• Interpreting and applying PV-related regulations/policies to processes and decisions made when required; providing cross-training to other team members in matters of PV, when appropriate.
• Cooperating with the audited functions and providing advice and support where required in execution of remediation actions (CAPAs) to ensure compliance to regulatory and Global Quality expectations and requirements.
• Approving CAPAs and regularly reviewing progress and providing ongoing support in all PV compliance matters.
• Contributing to the Global Quality Assurance (GQA) team by conducting peer review of audit reports conducted by other team members.
• Contributing to the continuous improvement and maintenance of the GQA and Global quality management system (QMS) by writing SOPs and guidance documents.
• Providing expertise to enhance audit tools and templates in PV and updating PV report templates, checklists, and other documents as required and requested by the GQA Director.
• Acting as Subject Matter Expert/Point of Contact to provide expertise and knowledge to less experienced auditors, business partners and company entities on quality and compliance processes/procedures.
• Maintaining/enhancing Global Quality audit standards and procedures for harmonized One Audit Process.
• Completing all training requirements in a timely manner and responsible for ongoing maintenance of personal training records to ensure audit and inspection readiness at all times.

Qualifications

• An in-depth knowledge and experience of GxP guidance and global regulations for drugs/biologics.
• Demonstrable multitasking, project management, and execution skills.
• Oral and written proficiency in English, second language capability is preferred.
• Strong interpersonal skills and ability to develop interdepartmental relationships, including in communication, presentation, persuasion, and influence.
• Strong organizational and prioritization skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as Microsoft Office/Office 365. Experience with Trackwise is an advantage.
• Ability to travel up to 50% of the time and accommodate time zone differences in case of remote audits.

Education and/or Experience.

• At least a bachelor's degree in a scientific or health-related field, with a Master's degree preferred.
• 8 plus years of experience in pharmaceutical industries, with 5 years of experience in a Good Pharmacovigilance Practices (GVP) function/environment.
• Certification as a Quality auditor with at least 5 years of PV auditing experience, primarily as lead auditor.
• 2 years of experience in Regulatory Inspections Management (e.g. MHRA, FDA, EU inspections).
• Experience in multi-national/ remote-group work environment.
• Computer Systems Validation (CSV) experience is an advantage.

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.

EEO is the Law 
EEO is the law - Poster Supplement
Pay Transparency Policy

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.