Quality Assurance Manager

What Chemistry Services Center contributes to Cardinal Health

Chemistry Services Center perform laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of Quality, Regulatory & Medical Affairs (QRMA), Chem Services develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterize medical devices, materials, and processing aids for chemical properties of concern or the chemical constituents which may be released when a device is utilized during clinical use. The Chemistry Service will also use specialized instruments to perform Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical. Chemistry Services is a part of QRMA Scientific Services.

This role is 100% onsite at our state-of-the-art Scientific Service Center in Mansfield, MA.

Responsibilities

• Manage department operations and supervise QA/QC department.
• Develop and maintain quality assurance procedures, policies, and systems
• Create laboratory KPIs (Key Performance Indicators) to ensure effectiveness of quality system and efficiency of the lab operations
• Provide Quality Assurance review and analysis of data from pharmaceutical stability tests to ensure they meet established quality standards
• Thoroughly review and interpret analytical data generated from tests, identifying any deviations from expected results, quality issues, including out-of-specification results and taking appropriate corrective actions (e/g CAPA) to mitigate risks.
• Ensure adherence to Good Laboratory Practices (GLP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols.
• Review and approve stability studies, trending, and interpretation other relevant documentation to ensure accuracy, compliance, and to assess product for degradation and shelf-life prediction.
• Assist in the preparation and execution of regulatory inspections and audits. Participate in internal and external audits to assess quality systems and identify areas for improvement
• Perform risk assessments to identify potential quality issues and implement preventive measures.

Qualifications

• Bachelors degree in chemistry, pharmacy or a related scientific field, preferred or relevant work experience.
• Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, Karl Fisher and dissolution and related instrumentations, preferred.
• 8-12 years of experience in quality assurance within a pharmaceutical or biopharmaceutical manufacturing or testing environment, preferred.
• Strong knowledge of ICH guidelines, FDA regulations, Data Integrity, Quality Risk Management and other pharmaceutical regulatory requirements, preferred.
• Working knowledge of regulatory guidelines of analytical method verification, validation, and method transfer, preferred.
• Experience with submission and approval of laboratory accreditations (e.g. ISO 17025), preferred.
• Ability to support regulatory inspection including audit readiness and responses, preferred.
• Experience with investigations of Out of Specification (OOS) per FDA guidelines, preferred.
• Experience with quality management systems (e.g., TrackWise, Veeva or Agile), experience with LIMS (e.g., LabWare) is a plus.
• Experience with pharmaceutical stability test analysis software for data management, preferred.
• Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility.
• Excellent attention to detail and data analysis skills.
• Strong communication (both oral and written) and reporting skills.
• Ability to work in a fast-paced, cross-functional environment.

What is expected of you and others at this level

• Manage the day-to-day operations of the QA/QC department supporting Chemical Characterization of Medical Devices and Pharmaceutical Stability testing.
• Provide Quality Assurance review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
• Experience with Quality Management Software (QMS), such as Trackwise, Veeva or Agile and Laboratory Information Management System (LIMS), such as LabWare.
• Help develop with lab managers of pharmaceutical analysis department, provide inputs for development of instrument testing protocol and methods, standard operating procedures (SOPs), work instructions and other instrument documentation.
• Ensures that the necessary testing is performed according to the test specification, test method and working instructions and to ensure testing is completed in a timely and efficient manner.
• Review analytical method transfer and validation/verification protocols and reports.
• Possesses significant working knowledge of USP, FDA and ICH regulatory requirements as applicable to pharmaceutical stability testing.
• Possess a thorough understanding of Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) to ensure compliance of systems and procedures.
• Work with QA management, establishes, implements, and achieves a Professional Development Plan that maintains the incumbents high level of scientific and regulatory knowledge and expertise.
• Demonstrated initiative able to work proactively with no direct supervision and with a continuous improvement mind-set.

Anticipated salary range:$115,900 - $173,800

Bonus eligible:Yes

Benefits:Cardinal Health offers a wide variety of benefits and programs to support health and well-being.

• Medical, dental and vision coverage
• Paid time off plan
• Health savings account (HSA)
• 401k savings plan
• Access to wages before pay day with myFlexPay
• Flexible spending accounts (FSAs)
• Short- and long-term disability coverage
• Work-Life resources
• Paid parental leave
• Healthy lifestyle programs

Application window anticipated to close:8/1/2025 *if interested in opportunity, please submit application as soon as possible.

The salary range listed is an estimate. Pay at Cardinal Health is determined by multiple factors including, but not limited to, a candidates geographical location, relevant education, experience and skills and an evaluation of internal pay equity.

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Candidates who are back-to-work, people with disabilities, without a college degree, and Veterans are encouraged to apply.

Cardinal Health supports an inclusive workplace that values diversity of thought, experience and background. We celebrate the power of our differences to create better solutions for our customers by ensuring employees can be their authentic selves each day. Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, age, physical or mental disability, sex, sexual orientation, gender identity/expression, pregnancy, veteran status, marital status, creed, status with regard to public assistance, genetic status or any other status protected by federal, state or local law.