Associate Director, Quality

Your Role

This position is responsible for being Most Senior plant level Quality Management Representative developing and deploying the quality system for the plant assuring systems and procedures for regulatory compliance are established and deployed

• Serve as the Management Representative for Quality and lead the Quality organization within a mid-to-large manufacturing facility.

• Build and develop a high-performing Quality organization with a clear vision and mission that supports business growth and global expansion.

• Oversee batch review and product release activities.

• Fulfill the responsibilities of the Person Responsible for Regulatory Compliance (PRRC) including ensuring device conformity is appropriately verified in accordance with the Quality Management System before release.

• Ensure Post-Market Surveillance (PMS) obligations are fulfilled.

• Ensure vigilance reporting requirements are met in accordance with Articles 87-91 of the Medical Device Regulation (MDR).

• Direct large-scale programs and departmental initiatives in support of division-wide and company-wide objectives.

• Maintain accountability for product quality regulatory compliance and adherence to Baxter quality policies.

• Develop implement and maintain quality systems including Management Review CAPA Design Controls and Process Controls to ensure products meet defined requirements.

• Ensure compliance with applicable regulatory requirements and manage regulatory inspections and audits.

• Conduct periodic reviews of the Quality Management System with executive leadership to ensure effectiveness and continued suitability.

• Drive continuous improvement initiatives across processes and systems while supporting deployment of divisional and corporate quality programs.

• Assess and advise senior leadership on quality-related aspects of acquisition targets.

• Collaborate effectively with stakeholders across functions business units and global locations.

• Serve as the primary quality representative in interactions with customers and regulatory agencies regarding products systems and processes.

• Ensure adherence to established specifications procedures and standards supporting product quality and regulatory compliance.

• Develop and manage the Quality organization budget and ensure effective utilization of departmental resources.

• Lead coaching training performance management employee development and succession planning initiatives for the Quality team.

• In-depth knowledge of the regulatory environment governing the manufacture of medical devices and therapeutics.

• Proven leadership experience managing large teams in a complex regulated environment.

• Demonstrated ability to lead within a matrix organization and collaborate effectively across global cross-functional teams.

• Strong analytical problem-solving and decision-making skills.

• Excellent verbal and written communication skills.

• Proven success working with multifunctional and global teams.

• Strong interpersonal influencing and negotiation skills.

• Extensive knowledge of applicable quality systems regulatory standards and industry regulations.

• Experience in risk management validation analytics and microbiology within a GMP-regulated environment.

• Quality expertise supporting technology transfer initiatives.

• Ability and willingness to work within ISO 7 and ISO 8 cleanroom manufacturing environments including required gowning procedures.

• Bachelors degree in Science Engineering or a related technical discipline required; advanced degree preferred.

• Minimum of 10 years of experience in Quality Manufacturing or a related field within the medical products industry.

• Minimum of 7 years of management experience.

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 $160000 - $220000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors all of which are subject to change. Individual pay is based on 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.