Quality Control Device Manager

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make

The Quality Control Device (QCD) Manager will be primarily based in the Maryland Heights Manufacturing building and will provide general oversight to the QCD Laboratories.  The QCD Manager develops, directs and leads the QC Device testing laboratory, supporting the testing of incoming components (packaging materials, preassembled components, labeling, and support material) and final product testing (release and stability) for functionality attributes for release for St. Louis Operations.  

Role Responsibilities

• This position leads a team of colleagues supporting three shifts with a wide range of responsibilities.  The incumbent is responsible for the development, mentoring, and performance management of a team of laboratory analysts and supervisors.
• Become the SME and main POC for the QC Device laboratory and processes, including methodology and instrumentation.
• Ensure documentation practices and systems are in place in compliance cGMPs and standard operating procedures.  
• Work with management teams to ensure programs are in place to support and measure technical skill development.
• Partners with other KDD groups to support identified learning initiatives, as needed. Participates in network meetings to bring in Best Practices where required.
• Supports operational excellence and site transformational initiatives.
• Facilitates M1 investigations when required.
• Support process to hire, develop, coach, reward and monitor training and communication staff members. 
• Set and implement objectives and development plans for direct staff as well as indirect departmental and on-the-job training.
• Support regulatory inspections and audits, respond to requests and findings, and track commitments for QC Device Lab operations.
• Support communication process improvements throughout the site and enable replication of good practices between sites.
• Support production of site-wide meetings and special events and visits.

 Basic Qualifications

• Bachelor degree in Engineering, Microbiology, Biology, Chemistry or related technical physical science.  
• 7+  years of related experience and 4+ years of experience in GMP laboratory environment.  
• Previous supervisory experience of colleagues.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports (as needed), and legal documents; comprehend equipment manuals and translate operational limits into protocols acceptance criteria; respond to regulatory agencies; and respond to complaints from customers.  Ability to gather and analyze information skillfully and present in many forms.
• Experience in several of the following areas: GMP, Regulatory (worldwide), deviation investigation, drug product lot release, device testing practices, product and process validation, laboratory testing and investigations, and batch record review. 

Preferred Qualifications

•    Master Degree in related discipline. 
•    Knowledgeable of current trends in laboratory and testing standards and regulatory compliance requirements for Pharmaceutical/Device manufacturing (FDA, EU).

#LI- On-Site

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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