Associate Director, Quality,

About the Role

This position is the most senior plant-level Quality Management Representative, responsible for developing and deploying the quality system for the plant and ensuring systems and procedures for regulatory compliance are established and maintained.

Responsibilities

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

Requirements

• 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.

Qualifications

• Bachelor's 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.
• Applicants must be authorized to work for any employer in the U.S. (Baxter is unable to sponsor or take over sponsorship of an employment visa at this time).

Pay

The estimated base salary for this position is $160,000 - $220,000 annually. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

Benefits

• Medical and dental coverage starting on day one.
• Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident.
• Employee Stock Purchase Plan (ESPP) with the ability to purchase company stock at a discount.
• 401(k) Retirement Savings Plan (RSP) with company matching options.
• Flexible Spending Accounts.
• Educational assistance programs.
• Paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave.
• Commuting benefits.
• Employee Discount Program.
• Employee Assistance Program (EAP).
• Childcare benefits.