Director of Quality Assurance - Life Sciences

About the Position

The Dir – Quality is responsible for establishing and maintaining priorities, focus and operational standards for Kenco’s quality and regulatory (related to quality) commitments and activities.  The position will be responsible for advancing and supporting relevant standards, principles, and practices within corporate activities and at Kenco’s distribution/warehouse sites.  This role will consequentially manage the functions pertaining to the development, implementation, and maintenance of the Quality pillar within the Kenco Operating System (KOS).  General management, advancement and use of Kenco’s EQMS (Electronic/Enterprise Quality Management System) shall also be an integral function and accountability of this position.  This position will also be responsible for the direct management of Kenco’s Corporate Quality Managers and have secondary oversight of site-level quality associates. 

 

Functions

• Responsible for developing, promoting, and implementing a proactive and engaged quality/regulatory (as applicable) culture throughout the organization. 
• Responsible for the development, implementation, training and maintenance of all policies, procedures, and programs to maintain quality and regulatory compliance.
• Lead the management, advancement and use of Kenco’s EQMS (Electronic/Enterprise Quality Management System).
• Evaluate quality and regulatory impact and deliverables following customer and/or distribution/warehouse site changes – e.g., new or departing customers, physical site changes, etc.
• Collaborate with operational leaders, site leadership and site associates on scheduled audits and unexpected site matters, including any corrective measures following an inspection, audit and/or investigation.
• Provide technical direction and support to site leadership and associates.
• Foster engagement and knowledge of quality requirements and practices at distribution/warehouse sites through communicating corporate procedures, coaching, training, and follow-up on issues related to quality.
• Analyze the company’s critical quality and, as applicable, regulatory (related to quality) requirements, identifying deficiencies and opportunities, and developing innovative and strategic initiatives/solutions to foster compliance with requirements and best practices.
• Assume a leadership role of the Quality pillar within the Kenco Operating System (KOS).
• Assist in the development, maintenance, and oversight of corporate and departmental data to advance standardization and accuracy.
• Provide leadership oversight (direct and indirect) to Corporate Quality Managers and site-level Quality associates.
• Develop, strengthen, and sustain productive and collaborative working relationships with all levels of the organization to promote sound and engaged quality/regulatory practices.

 

Qualifications

• Bachelor’s or Master’s degree from a four-year college or university.
• Minimum of 5 years of experience in quality, regulatory management and/or related discipline required.
• Professional quality and/or regulatory certifications preferred.
• Minimum of 5 years of experience of managing quality/regulatory professionals and projects.
• Knowledge in pharmaceutical, medical device, food manufacturing/warehousing, compliance and/or regulatory affairs.
• Strong organizational, communication and project management skills. 

 Competencies

• Collaborative Leadership - Knows how to get things done through formal channels and the informal network while instilling a sense of purpose in others; sees connection to larger purposes.   
• Communicate for Impact - Devoting the time and resources necessary to communicate the strategic vision, direction, priorities, and progress of the team for which you are responsible. 
• Customer Relationship Building - Having an intimate knowledge of the customer's changing needs and the ability to produce rapid results in all areas. 
• Financial Acumen - Maintains and applies a broad understanding of financial management principles to ensure decisions are fiscally sound, responsible, and are strategically aligned.  
• Leading Change - Ability to develop and implement an organizational strategy and to incorporate it into the organization’s long-term goals. Foster a work environment that encour