Sr. Quality Management Specialist

Overview

Being on medication is tough enough.
We want to make getting it the easy part
.Getting prescriptions to patients has become increasingly complex. When things get messy along the prescription journey, pharmaceutical manufacturers rely on us to untangle the process and create a clear path—allowing patients to build trusting relationships with their medication brands.

We’re not only committed to taking the pain out of the prescription process, but we’re also devoted to bringing the brightest minds together under one roof. We bring together diverse voices—engineers, pharmacists, customer service veterans, developers, program strategists and more—all with one vision. Each perspective and experience makes Connective Rx better than the sum of its parts.

The Sr. Quality Management Specialist utilizes broad experience in Quality System Management to ensure that Connective Rx’s Quality Management System conforms to internal policies, applicable regulations, and customer expectations. Additionally, the Sr. Quality Management Specialist leverages expertise in Quality Improvement to drive meaningful enhancements to critical business process and systems.

Under limited direction of the Manager, the Sr. QMS Specialist is responsible for coordinating and leading activity related to Deviations and CAPAs, document changes, vendor qualification and vendor risk management, training, as well as coordinating, supporting or leading (as necessary) customer, third-party and/or regulatory audits, and supporting activities aimed at Quality Improvement initiatives. The Sr. QMS specialist will act as a subject matter expert and adviser for other teammates within the Enterprise Quality Management department and throughout the organization.

The Sr. QMS Specialist provides valuable insights to influence and drive change within all areas of the business. The incumbent will play an active role in maintaining and building enterprise quality management processes and controls and works to maintain a constant state of audit-readiness.

• Provide guidance and advice to other Quality personnel, internal groups and project teams on matters pertaining to the Quality System.
• Coordinate and lead work for management of Deviations and CAPAs, including root cause analysis, corrective and preventive actions, and effectiveness checks.
• Lead and/or support internal, vendor and external audits as needed. Maintain a constant state of audit-readiness. Manage any necessary follow-up actions resulting from audits to ensure satisfactory audit closure.
• Calculate, record and analyze Quality System data and report and present Key Performance Indicators to management and/or customers. Identify areas of greatest need or opportunity for improvement.
• Cooperate with other Quality personnel and Connective Rx Teammates to support Continuous Quality Improvement initiatives.
• Review and process Document Change requests for new/revised controlled documents. Coordinate routine (annual, semi-annual) controlled document reviews with document owners.
• Maintain and routinely evaluate training assignments and training plans for the Connective Rx electronic Learning Management system. Routinely assess training compliance and intervene to address training compliance problems.
• Participate in and provide Quality expertise to complete Vendor Risk Assessments in partnership with Information Security and Procurement. Assist Information Security, Procurement, and the Business Relationship Owner in managing and remediating any identified risks for approved vendors.
• Assist HR and IT with employee onboarding and orientation.
• Other duties as assigned

• Bachelor’s degree or equivalent in a science, quality, healthcare or related field.
• 5-7 years of experience in quality systems management including a minimum of 3 years of effectively leading internal, third-party, client and/or regulatory audits and successfully leading cross-functional teams/projects at Enterprise scale.
• One or more of the following professional certification sis desired:
  Lean/Six Sigma Green Belt or Black Belt certification (CSSGB or CSSBB), Certified Project Management Professional (PMP),…