Quality Assurance Manager

About the Position

The Site Quality Assurance Manager will develop and manage the corporate quality management system within the GMP Distribution Center and ensure that processes and procedures comply with applicable standards and customer requirements. The manager will serve as the site leader in developing documents and tools to guide and improve the business, ensure cGMP compliance, mentor existing sites, and support new business generation.

The role will also support and assess the implementation of the Kenco Operating System as it relates to quality assurance.

• Supports the development and deployment of the Kenco Operating System & SOPs as it relates to the quality management system.
• Develops and deploys quality assurance / GMP trainings, procedures and tools in collaboration with other departments to improve the quality management system.
• Oversees the development and deployment of the internal auditing program as it relates to the quality management system.
• Assists with and performs Root Cause Investigations, Risk Assessments, and Trend Analysis (Data Analytics).
• Acts as the strategic leader in improving the quality management system and partners with operational leadership to identify areas of opportunity for continuous improvement.
• Maintains awareness of changing GMP / industry standards and educates affected sites on the impact of those changes.

• Bachelor’s degree in engineering or related field required.
• Advanced business qualification (e.g., MBA) may be an advantage but is not essential.
• Minimum of 5 years’ experience in cGMP standards, quality assurance management; regulatory affairs experience (FDA, DEA, etc.) desired.
• Expert knowledge and experience in ISO 9001:2015 ASQ or other accredited certification; ISO lead auditor preferred.
• ASQ CSSGB preferred.

• Business Acumen – Knowledgeable in current and possible future policies, practices, trends, technology, and information affecting your business and organization.
• 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.
• Leading People – Ability to develop and implement strategies to maximize employee performance and foster employee engagement in meeting the organization’s strategy.
• Managing Transitions / Change Management – Effectively plans, manages and communicates changes in processes with appropriate stakeholders.
• Relationship Management – Building and maintaining relationships with internal partners to successfully complete projects and organizational objectives.
• Strategic Agility – Gains perspective and balances the pressure between daily tasks and strategic actions that impact the long‑term viability of the organization.

This position is expected to travel approximately 10-15% of the time.

• Medical insurance including HSA, HRA and FSA accounts
• Supplemental insurance including critical illness, hospital indemnity, accidental injury
• Dental insurance
• Vision insurance
• Basic life and supplemental life
• Short-term and long-term disability
• Paid parental leave
• 401(k)
• Paid time off approximately 2 weeks (accrual begins on Day1 of employment)
• Employer-paid holidays – 10 days

Kenco is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.