Quality Assurance Manager
About The Position
The role of the Site Quality Assurance Manager is to develop and manage the corporate quality management system within the GMP Distribution Center and ensure that processes and procedures are developed in line with applicable standards and customer requirements. The Quality Assurance Manager will serve as the site leader in developing documents and tools to guide and improve the business, ensure cGMP compliance, serve as a mentor to existing sites and assist in the generation of new business. The role will also support and assess the implementation of the Kenco Operating System as it relates to quality assurance.
Requirements
- A Bachelor’s degree in engineering or related field required.
- 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 as ISO lead auditor preferred
- ASQ CSSGB preferred
- Business Acumen - Knowledgeable in current and possible future policies, practices, trends, technology, and information affecting his/her 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.
Nice To Haves
- An advanced business qualification (i.e. MBA) may be an advantage but is not essential.
Responsibilities
- 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.
- Assist with and performing 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 its continuous improvement.
- Maintains awareness of changing GMP / industry standards and educates affected sites on the impact of those changes.
Benefits
- 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 Day 1 of employment)
- Employer Paid Holidays- 10 days
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What This Job Offers
Job Type
Full-time
Career Level
Manager
