Sr. Quality Management Specialist

ConnectiveRx • Pittsburgh, PA

1d • $54,300 - $89,400

About The Position

The Sr. Quality Management Specialist utilizes broad experience in Quality System Management to ensure that ConnectiveRx’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.

Requirements

• 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.

Nice To Haves

• One or more of the following professional certifications is desired: Lean/Six Sigma Green Belt or Black Belt certification (CSSGB or CSSBB), Certified Project Management Professional (PMP), Quality Auditor Certification (CQA), Quality Improvement (CQIA), Process Improvement (CQPA), Supplier Quality (CSQP), ISO9001:2015 Auditor or equivalent(s).

Responsibilities

• 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 ConnectiveRx 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 ConnectiveRx 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

Benefits

• medical, dental, vision, life, and disability insurance
• 401(k) plan, with employer contributions where applicable
• flexible paid time off (PTO) policy for exempt employees, covering sick days, personal days, and vacations
• eight standard company holidays and three floating holidays annually

What This Job Offers

• Job Type: Full-time
• Career Level: Senior