Manager, Quality Systems

Primary Accountabilities:

• Develop and deploy the cGxP based Inmar Quality Management System
• Responsible for management of Quality Documents and related documentation
• Develop and deliver quality training to Inmar Associates
• Responsible for the implementation of QC Metrics to support SOC and Client requirements
• Work cooperatively with facility management to continually improve the quality process
• Collaborate with Inmar customers to ensure quality compliance with Service Level and Quality Agreements
• Train, coach, mentor and develop direct reports to effectively perform their responsibilities
• Develop team goals and execute monthly coaching sessions

 Required Qualifications:

• Bachelor’s degree in Quality, Business, Logistics, Engineering or a related field
• 5+ years of experience in a quality management in a logistics, pharmaceutical, manufacturing or similar environment, or any equivalent combination of experience and training that provides the required knowledge, skills, and abilities needed to complete the major responsibilities/essential functions of the position
• ISO 9001 experience or FDA CFR familiarity
• cGMP experience
• Lean Six Sigma certification a plus

Individual Competencies:

• Adaptable: Responds to change with a willingness to learn new ways to accomplish work.
• Analytical and critical thinking – Ability to tackle a problem by using a logical, systematic, sequential approach.
• Problem Solving: Gathers and analyzes information to generate and evaluate potential solutions to problems, issues and challenges while weighing the accuracy and relevance of the facts, data and information.
• Collaboration: Works collaboratively with others to achieve group goals and objectives.
• Communication: Giving and receiving messages and information in written, oral, and visual formats in a clear and concise way for a complete understanding of meaning and intent.
• Curious: A desire to inquire and learn, to seek new knowledge and wisdom, and to listen to the contributions of others with a genuine interest to better self, the team, and the organization.
• Teamwork: Builds relationships and works cooperatively with others, inside and outside the organization, to accomplish objectives to build and maintain mutually-beneficial partnerships, leverage information and achieve results.
• Integrity: Gains the trust of others by taking responsibility for own actions and telling the truth.
• Urgency: Transfers mission to action by acting clearly and decisively to analyze and implement solutions and maintains a sense of urgency to complete tasks, accomplish goals and complex situations (such as M&A tasks)
• Innovative: Ability to develop, sponsor, or support the introduction of new and improved methods, products, procedures or technologies
• Coaching: Guides, develops, empowers, and motivates associates to meet the organization’s goals while preparing the team to win

The physical demands described here are representative of those that must be met by an associate to successfully perform the major job responsibilities (essential functions) of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the major job responsibilities. This job description is not intended to be an exhaustive list of all duties, responsibilities, or qualifications associated with the job.

While performing the duties of this job, the associate is: 

• Regularly required to use hands to finger, handle or feel objects, tools or controls, and reach with hands or arms.

• Regularly required to talk or hear and read instructions on a computer monitor and/or printed on paper.

• Rarely required to stand, kneel or stoop, and lift and/or move up to ## pounds.
• Regularly required to view items at an extremely close range and must be able to adjust and readjust focus.

Safety:
 

• Support a safe work environment by following safety rules and regulations and reporting all safety hazards.

As an Inmar Associate, you:

• Put clients first and consistently display a positive attitude and behaviors that demonstrate an awareness and willingness to listen and respond to clients in order to meet their short-term and long-term needs, requirements and exceed their expectations.

• Treat clients and teammates with courtesy, consideration and tact; you also have the ability to perceive the needs of internal and external clients and communicate effectively with the objective of delighting and retaining the client.
• Build collaborative relationships and work cooperatively with others, inside and outside the organization, to accomplish objectives, develop and maintain mutually-beneficial partnerships, leverage information and achieve results.

• Set and attain achievable, yet aggressive, goals with a sense of urgency and accountability.
• Understand that results are important and focus on turning mission into action to achieve results following the principles of Flawless Execution while consistently complying with quality, service and productivity standards to meet deadlines and exceed expectations by giving our clients the best possible outcome.