Senior Drug Product Quality Manager

Evotec•Redmond, WA

1d•Hybrid

About The Position

The DP-PQL is a member of the Product Quality Team within the Quality organization and is responsible for ensuring the highest product quality and maintaining adherence to all applicable regulations, standards, and guidelines related to DP manufacture and release. This PQL works closely with Just-Evotec's Process & Product Design, Manufacturing Science & Technology, and Quality Control teams as well as the Client to provide assurance and oversight of technical aspects of DP Quality throughout the lifecycle of the product. The DP-PQL will support activities ranging from new product introduction, technology transfer, process and performance qualifications, commercialization, continuous process verification, and DP disposition.

Requirements

Bachelor's degree Life/Health Sciences; master’s degree and/or Ph.D. a plus.
Minimum 10 years’ experience in biopharmaceutical or related industries in manufacturing, Product Development or MSAT, QC or QA .
Experience at CDMO a plus.
Drug Product experience is strongly desired.
Knowledge of FDA, EMA and MHRA regulations and guidelines.
Experience with biosimilar filings a plus.
Excellent verbal and written communication skills.
Knowledge of QMS and CAPA related processes and systems is required.
Ability to work across functional areas and foster a collaborative culture of quality within the organization.
Experience with NDA and/or BLA submissions and Inspection readiness for Sponsors is strongly desired.

Responsibilities

Responsible for ensuring product quality throughout product lifecycle.
Partner with all relevant departments to ensure timely completion of deliverables for NPI, tech transfer, PPQ, and CPV.
Act as single point of contact for Quality issues with Client Quality organizations.
Execute DP disposition, ensuring compliance with internal and cGMP expectations for Drug Product batches manufactured at contracted CMOs.
Manage the QA communication and disposition process with CDMO client base.
Oversee the shipments of DS/DP to CMOs for fill/finish activities.
Maintain strong relationships with multiple internal and external team members and cross functional groups.
Support the development and/or improvement of SOPs related to PQL activities and maintain a mindset for continuous improvement and learning.
Perform quality document review and approval as required.
Oversee investigations of product related quality issues, deviations, and root cause investigations.
Support internal and client audits of the quality management systems.
Identify and escalate compliance risks associated with their area of responsibility.
Participate in strategic development of Quality Systems.
Travel to JEB local and international sites as required.