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    Sr. Quality Technical Consultant - London, United Kingdom - Baxter

    Baxter
    Baxter London, United Kingdom

    1 week ago

    Default job background
    Full time
    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. 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.

    Responsible for supporting Baxter's 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, utilizing 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 competencies.

    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


    • Performs Quality Management System (QMS) compliance audits as а 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

    Qualifications .

  • Thorough knowledge of applicable Global regulations and standards
  • Demonstrable multitasking, project management, and execution skills
  • Must be willing to travel up to 50% both domestically and internationally
  • 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)

    • Education and/or Experience.

  • Bachelor's Degree (Science or Engineering preferred)
  • Microbiology background desirable
  • Minimum оf 7+ years оf experience in Quality, Compliance, Manufacturing, Engineering or related field
  • 5+ years of management experience preferred
  • Past experience as an FDA Inspector desirable
  • Independent Certifications desired (e.g. CQA, RAPS)

    • What are some of the benefits of working at Baxter?

  • Competitive total compensation package
  • Professional development opportunities
  • High importance placed on work life balance
  • Dedication to growing and developing an inclusive and diverse workforce

    • #IND-UKOPS

    #LI BAX-GEN

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