Sr. Supervisor, Quality Operations

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

In this role, you will direct and lead Quality Oversight of clean and prep, formulation, filling and QA disposition activities at the Bridgeton campus for St. Louis Operations.  In support of site wide objectives, supervises floor support activities, reviews and may be delegated to approve area documents such as Batch Records, Environmental Compliance records, SOPs, deviation investigations, validation protocols and reports, CAPAs and Change Requests.  Quality support with a focus on microbial and particulate control in support of aseptic production activities programs involving microbial control in production areas – cleaning and sanitation, disinfectants, training programs, etc.

Coordinates quality support of validation related activity and production preparation and operation.  Engaged with cross functional teams as needed to support continuous improvement activities.  Requires decision making ability related to Incident Investigation initiation, with emphasis on overall quality, site priorities, results and achievements.

ROLE RESPONSIBILITIES

• Implement and execute procedures to assure compliance

with regulatory requirements and internal policies.

• Provide feedback as requested to continuously improve technical training effectiveness and efficiency. Implements appropriate and aligned solutions as directed.
• Supports operational excellence and site transformational initiatives.
• Support for processes to hire, develop, coach, reward and monitor training and communication staff members.
• Set and implement objectives and development plans for direct staff.
• Work with site leadership to develop site specific messaging including site objectives.
• Support communication process improvements throughout the site and enable replication of good practices between MMT sites.
• Support production of site-wide meetings and special events and visits.

QUALIFICATIONS

• Bachelor of Science Degree in Microbiology, Biology, Chemistry or related Technical Physical Science or minimum of 10 years of pharmaceutical experience.
• Minimum of three years progressive experience in GMP Pharmaceutical Manufacturing environment. 
• Minimum of previous team leader/supervisory experience.

Technical Skills Required

• Knowledgeable of current cGMP manufacturing standards.
• Knowledge of regulatory compliance requirements for Pharmaceutical/Biological manufacturing (FDA,  EU) preferred.
• Excellent oral and written communication skills, tailored to the audience or recipient of the communication.  Prefer presentation skills adequate to the immediate Quality team and Production team
• Demonstrated track record of organizational skills and attention to details. 
• Strategic thinking at a department level.
• Ability to translate complex issues and accomplishments into language and messaging of general interest.
• Passion for support of an engaged and change-agile culture.
• Commitment to quality and customer service.
• Excellent computer skills including experience with Word, Outlook, PowerPoint, Excel.

PHYSICAL/MENTAL REQUIREMENTS

• Position requires ability to sit and or stand for extended periods and to work in a variety of settings including office areas, production, warehouse, and  some occasional time spent in clean room classification zones.  Additionally, the ability to drive between the local St. Louis sites is necessary (approx. 11 miles apart).  Ability to travel (limited basis).
• Training presentations may be required to be delivered on primary shift for this role, 3^rd Shift.
• Position requires regular onsite attendance – this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis.
• Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls.  Note that these activities may not be time bound to core hours or presence at the site.
• Must have the ability  to work effectively under and manage to strict production, time and performance deadlines.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS  

• Must be willing and able to work beyond the hours typically defined as a “regular” workday, which may or may not include weekends and holidays.
• Must be able to gown aseptically and be able to audit the aseptic areas regularly.

#LI-Onsite

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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