Associate Director, Quality

Baxter International Inc.; Hayward (CA); On-site; USD 160,000 - 220,000; Full time

Job summary

Baxter International Inc. in Hayward, CA, seeks a Most Senior plant-level Quality Management Representative to develop and deploy the plant's quality system and ensure regulatory compliance before product release.

You will lead the Quality organization, oversee batch review and product release, and drive CAPA, Design Controls, and Post-Market Surveillance while partnering with global teams to meet business objectives.

Qualifications

• Bachelor's degree in science, engineering, or related technical discipline.
• 10+ years in Quality, Manufacturing, or related field within medical products.
• 7+ years of management experience in a regulated environment.
• Experience with regulatory compliance and medical device standards.
• Ability to work in ISO 7/ISO 8 cleanroom environments.

Responsibilities

• Serve as the Management Representative for Quality and lead the Quality organization within a large manufacturing facility.
• Build and develop a high-performing Quality team with a clear vision and mission.
• Oversee batch review and product release activities.
• Fulfill the responsibilities of PRRC and ensure conformity before release.
• Ensure Post-Market Surveillance obligations are fulfilled.
• Drive continuous improvement across processes and systems.
• Collaborate with stakeholders across functions and global locations.
• Serve as primary quality representative with customers and regulators.

Skills

Regulatory compliance

Leadership

Quality systems

CAPA

GMP

Data analysis

Cross-functional

Education

Bachelor's degree

Advanced degree preferred

Tools

QMS (Quality Management System)

Regulatory inspections

Job description

This is where your work makes a difference.

At Baxter, we believe every person - regardless of who they are or where they are from - deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job—you will find purpose and pride.

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.

What You'll Bring

• 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.

Education & Experience

• 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.

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 $160,000 - $220,000 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.

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.

US Benefits at Baxter (except for Puerto Rico)

• Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.
• Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.
• We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as 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.
• Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.
• Join us and enjoy the competitive compensation and benefits we offer to our employees.

For additional information regarding Baxter US Benefits, please visit our Benefits site: Benefits | Baxter

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.