Stability Manager

Cardinal Health•Mansfield, MA

About The Position

What Chemistry Services Center contributes to Cardinal Health The role is located at the Chemistry Center under the Scientific Services. Chemistry Center performs laboratory testing to characterize the chemistries of our medical device products and stability testing for pharmaceutical products of Cardinal Health. Under the umbrella of QRMA, SSCC develops and executes test protocols utilizing specialized instrumentation and analytical techniques to characterize medical devices, materials, and processing. The Chemistry Center performs Assay and impurity/degradant tests for stability and release testing for solid dose pharmaceutical. Chemistry Services is a part of QRMA Scientific Services.

Requirements

Experience with Quality Management Software (QMS), such as Veeva or Agile and compliance software like Laboratory Information Management System (LIMS), such as LabWare.
Prior people management experience including supervisors, scientists and analysts
Experienced with authoring of standard operating procedures (SOPs), work instructions and other instrument documentation.
In-depth knowledge of 21CFR compliance
Author/Review analytical method tech-transfer, Qualification 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 incumbent’s 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.
B.S. in chemistry. pharmacy or a related scientific field preferred.
Strong knowledge of analytical techniques such as HPLC, GC, UV-Vis, Karl Fisher and dissolution and related instrumentations.
8-12 years of experience in quality control 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.
Working knowledge of regulatory guidelines of analytical method verification, validation, and method transfer.
Experience with submission and approval of laboratory accreditations (e.g. ISO 17025)
Ability to support regulatory inspection including audit readiness and responses.
Experience with investigations of Out of Specification (OOS) per FDA guidelines.
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 is required.
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.

Responsibilities

Ensure adherence to Good Manufacturing Practices (GMP) regulations, including proper documentation, standard operating procedures (SOPs), and quality control protocols.
Manage all aspects of stability operations and provide leadership to multiple supervisors
Manage all aspects of sample, reagent management, on-time testing of stability samples, and stability walk in room and chamber management, and work with Facilities, EHS, QA, Regulatory and related departments to ensure GMP compliance adherence.
Provide technical review and analyzing data from pharmaceutical stability tests to ensure they meet established quality standards
Develop Laboratory KPI’s to ensure effectiveness of quality system and efficiency of the lab operations
Responsible for managing deviations and Root Cause Analysis that are resulting from Stability testing.
Investigate any identified quality issues, including out-of-specification results, and taking appropriate corrective actions (e.g., CAPA) to mitigate risks.
Investigate deviations from standards, documenting findings, and collaborating with analytical test teams to identify and address potential quality issues.
Participating in internal and external audits to assess quality systems and identify areas for improvement.
Collaborate across departments to ensure product integrity and shelf-life requirements are met during testing. Performing risk assessments to identify potential quality issues and implement preventive measures.
Coordinate with cross-functional teams to manage stability study timelines and deliverables. development, execution, and data analysis.
Prepare, present and defend capital and non-capital budgets consistent with corporate priorities
Oversee the stability study lifecycle, including protocol Stay current with industry regulations, guidelines, and best practices.
Manage GMP readiness for the stability labs.
Provide training to staff or cross-functional teams on quality-related procedures and best practices.

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