Associate Director, Quality Assurance

Company: Fresenius Kabi US
Location: Melrose Park
Posted on: March 19, 2023

Job Description:

Job Summary

POSITION SUMMARY

Collaborates with the Director, Quality Assurance to provide cGMP guidance to all departments engaged in the production of pharmaceutical products; responsible for supporting the company's short- and long-term goals for maintaining Quality Systems and supporting Compliance. This includes direct oversight for the evaluation, implementation, execution and follow-up on quality systems in support of GMP compliance and release of finished product.

Responsible for quality assurance oversight of the manufacturing and packaging processes and procedures; which allow for the accurate and timely review of the manufacturing and packaging batch record documentation to support product release. This includes oversight for the final review of investigations to ensure product quality, and appropriate implementation of corrective actions in a timely manner to prevent recurrence.

Performs analysis on quality and manufacturing indicating data and recommends actions for compliance and process improvement. Works in partnership with cross-functional departments to solve problems and provide expertise on compliance issues and quality policy requirements.

Provides input into the overall decision-making process pertaining to the quality problems internal and external that can have far reaching results in terms of rejected batches, stock withdrawals, quarantined goods, revised production and marketing schedules and added manufacturing costs.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT.

* Assists the Director, Quality Assurance in the administration of the Quality System in accordance with US Operations and Corporate policies and procedures.
* Provides daily oversight of the MQA and Aseptic Mentor teams responsible for supporting all production/processing areas. Develop, and monitor appropriate KPI's for batch documentation review, Right Frist Time (RTF) and support of 28-day batch release cycle.
* Responsible for department resource planning, talent development, and budget administration with regards to MQA and Aseptic Mentor personnel, equipment, and facilities.
* Directs investigations of product complaints and manufacturing discrepancies for manufactured products and ensures completion of appropriate documentation. Interacts with the Vigilance and Medical Affairs Department as needed.
* Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventative actions and appropriate effectiveness measures.
* Provides QA review and approval of Investigations, CAPAs, SOPs, Material Change Controls, CNs, DCRs, training documentation, and protocols/reports. Ensures completeness, accuracy and compliance of all documentation.
* Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics / KPIs.
* Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
* Independently and proactively seek new information to assure current status with compliance and regulatory issues through evaluation of available documentation, e.g. other company's 483/Warning Letters, cGMP Trends, new FDA Guidance Documents, PDA, etc.
* Has authority to make decisions for the PU QA department, serving as a back-up to the Director, Quality Assurance, including having their signature authority.
* Assumes additional responsibilities as assigned.

REQUIREMENTS

* Bachelor degree of Science with a minimum of 8 years of progressive challenging QA/QC experience, including 5 years as a manager or above, in pharmaceutical or related regulated industry.
* Advanced training or experience in cGMP and GLP, legal and ISO requirements.
* Must have excellent team leadership and interpersonal skills.
* Excellent verbal and written communication skills, negotiation and problem resolution skills.
* Must be organized, detailed and have ability to handle multiple tasks at once and redirect focus based on company's needs.
* Must be able to function independently with minimal supervision.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Keywords: Fresenius Kabi US, Chicago , Associate Director, Quality Assurance, Executive , Melrose Park, Illinois