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This job is with Baxter International Inc, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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.
Summary
Responsible for supporting Baxters Corporate Internal Audit program. Ensure compliance to company policies / regulations and standards globally. Collaborate cross-functionally within Baxter’s functions/businesses. Grow the auditing capability within Quality Assurance, applying expertise, knowledge and experience of best-practice methodologies and practices in industry.
To succeed in this role, the candidate should have extensive auditing experience within the drug and medical device areas. This role can be home-based but will require travel for audits primarily in EMEA / APAC (however there may be some in the US to support colleagues (around 50%). Travel may also be required for inspection support
What Youll do:
Performs Quality Management System (QMS) compliance audits as a team member and/or lead as the need arises
Interacts with all levels of internal Management across functions and business units
Communicates results of audits and internal control evaluations in reports and presentations
Evaluates audit responses for adequacy, including root cause, timeliness as well as applies knowledge to facilitate appropriate corrective action
Resolves complex issues and raises concerns through business and Quality Management
Serves as а cGMP consultant/subject matter expert and provides researched and supported opinions to complex compliance issues
As needed, participates in and/or supports preparation of regulatory agency inspections and/or responses to external observations
Maintains all organizational and professional ethical standards, while actively advocating and monitoring compliance
Actively supports continuous improvement of the audit program and Global Compliance
Participates in special projects/investigations as needed
Acts as а mentor/coach to guest auditors and new hires
We are looking for someone who has:
Thorough knowledge of applicable Global regulations and standard
Demonstrable multitasking, project management, and execution skills
Excellent verbal and written communication skills, including presentation skills
Strong courage of conviction, conflict resolution, interpersonal and influencing skills
Strong technical, analytical, judgment and problem-solving skills
Ability to establish relationships across functional boundaries at multiple levels internally /externally
Ability to independently make quick, sound decisions with limited data and implement appropriate judgment on when to escalate information
Ability to be self-motivated and work independently within defined timelines
Working knowledge of quality system software (e.g. Trackwise)
Role requires 50% travel
Education and/or Experience.
Bachelors Degree (Science or Engineering preferred)
Microbiology background desirable
Minimum оf 7+ years оf experience in Quality, Compliance, Manufacturing, Engineering or related field - with 5+ years of management experience preferred
Past experience as an FDA/MHRA or other body Inspector desirable
Independent Certifications desired (e.g. CQA, RAPS)
We offer
Fixed-term contract for 3 months and then for an indefinite period.
Competitive salary, annual bonuses, recognition award program.
Culture built on our values: collaboration, speed, courage and simplicity.
Possibilities for development on a personal and professional level in one of the leading global MedTech companies.
Package of benefits including Private medical care (Lux Med), Life Insurance, Multisport card.
Bax4U - cafeteria/lunch cards (300 PLN).
PPE program with very attractive conditions available for each employee after 3 months.
Educational support: fully covered language courses (English or other languages according to business needs), financial certifications (ACCA, CIMA).
Co-financing of holidays and an additional 2 days off from work annually.
Day off for birthday.
Employee Stock Purchase Plan.
Bax Flex - hybrid model - 3 days from the office.
Extraordinary Warsaw office location - Powiśle!
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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
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