Sr Manager Global Quality Assurance (Pharma)

Job Summary

The Sr. Manager, Manufacturing Quality US Supply Sites will assure that all activities associated with manufacturing of products within the portfolio of all sites manufacturing for distribution in the US comply with the Manufacturing Quality Assurance concept developed by the Competence Center Manufacturing Quality (CC MQ). The oversight will also extend to the assurance of coverage of the Laboratory Quality Assurance (LQA) activities as also outlined in the current global annex.

This position will have primary responsibility for the NAM sites and will work in close cooperation with colleagues in Europe and ROW, including other Competency Centers such as those responsible for Microbiology & Aseptic Technique and QC Standards. The position will have no direct reports but must work closely with the MQA heads at each site in scope and within the CC MQ, MQA Team.

Also included in the scope of responsibility is implementation and revision of the global SOPs to ensure sustainability of the training and harmonization of best practices that were established by the Compliance Enhancement Program (CEP).

Hybrid role with 25% travel in North America

Responsibilities

• This Sr Manager will serve as ambassador of Senior Managements vision of the desired Quality Culture behaviors.

• Responsible for contributing to the planning and execution of the MQA / LQA concept.

• Develops standards for MQA / LQA activities to promote harmonization across all regional sites and USSS.

• Implementation of the best practice standards established by Competency Centers throughout the Fresenius Kabi organization.

• Establish MQA / LQA touchpoints throughout entire manufacturing and assurance of oversight of the drug testing processes.

• Participate in ensuring global SOP implementation has been prioritized at all regional sites.

• Establish and monitor KPIs such as Right First Time (RFT), investigation timeliness and 28-day batch release.

• Provide weekly monitoring of all global complaints for signals and trends.

• Annual review assignment for formal check and content-wise check of Periodic Quality Reports for all current Fresenius Kabi sites.

• Participate in the annual review of the efficiency and impact of the MQA / LQA activities.

• Assignment of additional activities based off inspection readiness or inspection results, as determined by Senior Management.

Requirements

• Accomplished quality leader with relevant experience in pharmaceutical manufacturing operations.

o Significant quality manufacturing experience, 10+ years

o Thorough knowledge of cGMPs, ICH guidelines, other standards as applicable

o Proven leadership ability as influencer

• Bachelor's Degree required. Advanced degree in science or engineering preferred.

• Ability to effectively interact with NAM manufacturing and MQA teams to align with Competency Center strategies, including:

o Mentorship, knowledge transfer

o Decision making and troubleshooting

o GEMBA walks, 5S, Internal Audits, inspection readiness

o Investigations, root cause analyses, CAPAs, effectiveness checks

o Shop floor checks of batch documentation

• Demonstrated understanding of manufacturing system technology and ability to establish sustainable quality management system partnership.

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.