Compliance Manager
il y a 1 semaine
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.
About The role
At Baxter, we are passionate about saving and sustaining lives by finding solutions to complex problems. Every single day, the manufacturing team strives to build quality products for our customers—and are oftentimes met with unforeseen problems to solve. The talents at Baxter meet these challenges head-on, as a team, in an effort to build products with the customer’s needs top-of-mind.
Your team at Baxter
As Compliance manager you report directly to the Director of quality and provide leadership and strategy to ensure the development, implementation, and lifecycle management of Baxter quality system in line with the Baxter’s global QMS and drive compliance strategy for the site ensuring inspection readiness at all times along with a team of quality professionals. The Compliance manager reports directly to the Site Quality Head of Baxter Lessines.
What you will be doing
Develop, implement, and maintain quality systems policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA, EMA, and other relevant authorities. Provide strategic leadership and oversight for the management of quality systems, including but not limited to document control, change control, deviation management, CAPA, training, and audits. Training and Education: Design and deliver comprehensive compliance training programs for employees at all levels to promote awareness of compliance obligations and foster a culture of integrity and ethical conduct within the organization. Understands and deploys processes to assure conformance to regulations in a mid to large size plant of a large program or department. Manages regulatory inspections. Risk Assessment and Mitigation: Conduct regular assessments to identify potential compliance vulnerabilities and develop strategies to mitigate risks effectively. Monitor changes in laws, regulations, and industry trends to anticipate and address emerging compliance issues proactively. Monitoring and Auditing: Establish monitoring and auditing processes to evaluate the effectiveness of compliance controls and identify areas for improvement. Lead and participate in internal and external audits, inspections, ensuring timely responses and resolution of any findings or observations. Be the Quality Lead for appointed vendors in excipients, API’s and Packaging and be responsible for labeling and ensure that it follows the applicable standards. Investigations and Remediation: Lead investigations into compliance incidents, allegations of misconduct, or violations of policies and regulations. Implement corrective actions and remediation plans to address identified issues and prevent recurrence. Collaborate cross-functionally with various departments, including Quality Assurance, Regulatory Affairs, Manufacturing, and R&D, to drive continuous improvement initiatives and ensure alignment with quality objectives. Monitor key performance indicators (KPIs), data analytics and metrics to assess the effectiveness of quality systems and identify areas for improvement. Stay abreast of regulatory developments, industry trends, and best practices related to quality systems, and proactively implement necessary changes to maintain compliance and enhance operational efficiency. Regulatory Reporting and Documentation: Prepare and submit regulatory reports and filings as required by regulatory authorities. Maintain accurate and comprehensive documentation of compliance activities, including policies, procedures, training records, and audit findings.
Your Profile
Bachelor’s degree or equivalent in chemistry, pharmaceutical Sciences or related scientific field is required. Having a registered QP number is an asset. Minimum of 10 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry, with progressively increasing levels of responsibility Minimum 5-7 years’ experience managing people In-depth knowledge of relevant regulatory requirements, including cGMP, ICH guidelines, and pharmacopeial standards. Proven track record of successfully managing and implementing quality systems initiatives, including process improvements and compliance remediation activities. Experience with electronic document management systems (e.g., TW8) and other quality management software tools is desirable. You have experience with regulatory inspections and preparedness. You have experience of leading a team of experts and enjoy supporting, mentoring, and developing team members. Delivers dedicated timelines. Excellent written and verbal communication, presentation, and facilitation skills· Strong negotiation skills and significant experience in interacting with regulatory authorities Risk identification and problem solving skills Demonstrated ability to lead, mentor, and develop others for future growth and development Established relationships with regulatory authorities Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings. Must have English and French written and oral communication skills adequate to communicate with other team members. Strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate and influence stakeholders at all levels of the organization.-
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