Associate Director, Quality

Baxter•Hayward, CA

5d•Onsite

About The Position

This position is responsible for being the Most Senior plant-level Quality Management Representative, developing and deploying the quality system for the plant, and assuring systems and procedures for regulatory compliance are established and deployed. Baxter is redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Baxter colleagues are united by their Mission to Save and Sustain Lives. The company culture is driven by courage, trust, and collaboration, empowering individuals to take ownership and make a meaningful impact. They strive for efficient and effective operations and hold each other accountable for delivering exceptional results.

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.
Ability and willingness to work within ISO 7 and ISO 8 cleanroom manufacturing environments, including required gowning procedures.
Bachelor's degree in Science, Engineering, or a related technical discipline required.
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.

Nice To Haves

Advanced degree preferred.

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.

Benefits

Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
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
Paid parental leave
Commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
Childcare benefits