Sr. Manager, Quality Assurance (41125)

Company Summary: PuraGraft, a Young Innovations Company

PuraGraft represents the leading manufacturers of biomaterial solutions for bone and tissue regeneration. No single material can suit all medical requirements and indications. However, through PuraGraft® you have access to the widest choices of products.

At Young Innovations, we foster a dynamic environment where team members make an impact every day as part of a collaborative, inclusive culture. Together, we serve the dental profession and their patients, united in our mission of achieving a Lifetime of Oral Health™

We embrace diverse perspectives and encourage bold thinking, challenging traditional approaches with a bias for action. Whether you’re looking to expand your skills or grow your career, Young is here to support your goals and continuous learning. At Young, YOU are at the core of what we do.

Position Overview:

Reporting to the VP Quality Regulatory Affairs, the Sr. Manager, Quality Assurance will be tasked with ensuring Quality standards are met or exceeded in all facets of the multi-site operation. He/she will partner internally in the development and implementation of new or adjusted quality standards, policies, and procedures, as required at Kingwood, TX and Scottsdale, AZ.

You’ll like this role if:

• You enjoy leading a team, solving complex quality challenges, and turning data into practical improvements. You take ownership of compliance and thrive in a hands-on role supporting quality standards across multiple sites.

Why You’ll Love Working Here:

• Medium sized company – not too big, not too small – just enough to get things done and see your impact.
• Did we say benefits? Full medical, dental, vision, 401k, parental leave, paid holidays, paid time off, short & long term disability insurance, employee assistance program, and more!
• Lead and inspire a dedicated team, build meaningful relationships, and help your employees grow and succeed.

Who you’ll work with:

• You’ll report to the VP of Quality & Regulatory Affairs and lead Quality Associates supporting our Kingwood, TX and Scottsdale, AZ operations.
• You’ll partner closely with QRA, Sourcing, Distribution, and Production teams to strengthen quality systems and drive continuous improvement.

What You’ll Do:

• Act as the site’s Sr. Quality and Compliance Leader, and when necessary, as the site’s Designated Management Representative to ensure compliance with all regulatory, corporate and facility requirements.
• Ensure compliance of two sites.
• Ensure outstanding Quality System performance via monitoring and measuring of process performance, and driving any appropriate action, including issuing and follow-up on activities required for sourcing, warehousing, and distributing pharmaceuticals.
• Supervise & Manage Quality Associates and develop culture of collaboration and cross-functional success within the department and business.
• Reviews and monitors Quality metrics and reports trends, to determine if there is a need to escalate issues to the management.
• Perform, review and monitor the Quality Management processes which include but is not limited to:
• Ensure compliance with FDA, DEA and BOP requirements, including DSCSA traceability of pharmaceuticals.
• Oversee Regulatory activities associated with distribution licensing, drug distribution reports, and permits for warehousing and distribution of controlled substances.
• inspection and product release, label approval, calibration, warehousing controls, record retention, document control, training, control of non-conforming product, quarantined Products, control of access and drugs storage, including temperature monitoring.
• Host and manage internal and external audits. Ensure the site’s readiness for assessments and lead implementation of corrective actions.
• Effectively assess processes and identify opportunities for improvement.
• Review, Analyze and Report Statistical findings through critical thought and storytelling of key findings and opportunities to all levels within a matrixed organization.
• Partner with other departments to identify critical to quality metrics, and support the operationalization of monitoring and management to deliver improved performance across processes.
• Create effective and compelling visual materials/presentations that support the process/product improvement impact to the organization and adequately represent the impact to quality, cost and time.
• Define, track, and monitor key success measures associated with Quality Management Systems. Successfully deploy and support change management and appropriate training plans.
• Manage document control functions, including creation, review, and approval of procedures, work instructions and all other documentation for the Quality System.
• Manage the complaint handling system, including trending and review to identify opportunities for improvement.
• Manage the training of the Site, by maintaining the training log, tracking training completion of training by site personnel, creating training content and hosting group training as needed.
• Develop and host the Quarterly Management Review
• Manage the Recall process, from notification, tracking responses & expenses, reporting, and closure.
• Develop, refine, and/or maintain quality standards, policies, and procedures for the facility, including identifying, recommending, and fully implementing changes, in partnership with corporate QRA and local operations teams. Other duties as assigned

Qualifications

What You’ll Bring:

• Bachelor’s degree in technical field.
• Minimum of 3 Years of experience managing manufacturing and/or distribution of pharmaceuticals.
• Minimum of 3 Years of experience having direct responsibility for managing a Quality group.
• Direct experience managing FDA or DEA Inspections.
• Demonstrated proficiency in verbal and written communication in English, with the ability to convey information clearly, accurately, and professionally across all levels of the organization.

Travel Requirements

• Up to 15%

Work Environment:

Office Environment

This position is based in an office environment and is primarily sedentary in nature. It requires regular use of standard office equipment, including computers, phones, photocopiers, scanners, filing cabinets, and fax machines. Some roles may involve wearing a headset and sustained computer use for 8 or more hours per day. Employees may be required to sit, stand, or walk for extended periods, and occasional bending, lifting, or carrying items up to 50 pounds may be necessary.

Manufacturing/Distribution Environment

This position operates in a manufacturing plant environment. The role routinely involves working around machinery, equipment, and moving mechanical parts. The facility may be subject to varying temperatures, loud noise levels, and airborne particles such as dust or chemical fumes, depending on the area of the plant. This role may require periods of standing, sitting, or walking throughout the workday. Occasional bending, lifting, or carrying items up to 50 pounds may be necessary.

Specific vision abilities required by this job include close vision, depth perception and ability to adjust focus. While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, control, or feel; reach with hands and arms and talk. Hearing abilities required for this environment include being able to clearly hear and respond to audible alarms, production equipment, forklifts, and other machinery to maintain a safe work environment. Individuals must be able to distinguish and understand verbal communication including instructions, safety warnings, and team discussions, sometimes in an environment with moderate to high background noise.

US: Young Innovations, Inc. is an Equal Opportunity Employer and E-Verify participating employer.