Baxter Quality Manager II ( Analytics) in Marion, North Carolina

Quality Manager II – Analytics


About Baxter Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.

Essential Duties and Responsibilities: * Lead Technical personnel in laboratory for the following activities: o Protocol creation and execution

o Process validation and Mixing studies o Cleaning validation via swab and rinse o Test method validation o Instrumental analyses, ex. HPLC, ICP-MS, AA o Raw material evaluations o Stability studies o Elemental impurity studies o Data integrity o Lab investigations as applicable o Change control as applicable o Project updates with R&D

* Manage through subordinates the coordination of the activities of several sections or departments in the Quality organization. Is responsible for results in terms of compliance and/or product quality and conformance to regulations and Baxter quality policies.

  • Participate in quality assessments of internal operations and suppliers, to analyze compliance and assess risk.

  • Interacts frequently with internal staff, functional peer and senior management.

  • Participate in interactions with regulators and customers to represent the company products and processes.

  • Identify and manage continuous improvement projects with the objective of achieving quality, reliability and cost improvements.

  • Develop budget for department and ensures adherence to the budget.

  • Manage coaching, training and development of direct reports and team. Qualifications for this role:

  • Thorough knowledge of applicable procedures, specifications, regulations, standards to include CFR, USP, ISO, ICH.

  • Ability to manage / supervise a large team of employees.

  • Strong analytical and problem solving skills.

  • Strong communication and leadership skills.

  • Strong project management skills.

  • Ability to work odd shifts when line time is available.

  • BS in Chemistry or Chemical Engineering; advanced degree helpful.

  • 7 years in Quality, Manufacturing, Engineering or related field.

  • 5 years in a pharmaceutical or medical device environment.

  • 5 years of management experience.
    A Career That Matters Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
    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. EEO is the Law
    EEO is the law - Poster Supplement
    Pay Transparency Policy Reasonable Accommodations
    Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

Qualifications for this role:

  • Thorough knowledge of applicable procedures, specifications, regulations and standards.

  • Ability to manage / supervise a large team of employees.

  • Strong analytical and problem solving skills.

  • Strong communication and leadership skills.

  • Strong interpersonal, communication, influencing, negotiation skills.

  • Strong project management skills.

  • BS in science or engineering; advanced degree helpful.

  • 7 years in Quality, Manufacturing, Engineering or related field.

  • 5 years of management experience.

A Career That Matters

Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.

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.

EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy

Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail toAmericas_TTA@baxter.comand let us know the nature of your request along with your contact information.

Job: *Quality

Organization: *Global Operations - Manufacturing

Title: Quality Manager II ( Analytics)

Location: North Carolina-Marion

Requisition ID: 190000DF