Sr. Quality Management Specialist

About the role

As a Sr. Quality Management Specialist at ConnectiveRx, you will utilize broad experience in Quality System Management to ensure our Quality Management System conforms to internal policies, applicable regulations, and customer expectations. You will leverage expertise in Quality Improvement to drive meaningful enhancements to critical business processes and systems. This role involves coordinating and leading activities related to Deviations, CAPAs, document changes, vendor qualification, training, and audits, while acting as a subject matter expert and adviser across the organization.

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, maintaining a constant state of audit-readiness.
• Manage follow-up actions resulting from audits to ensure satisfactory closure.
• Calculate, record, and analyze Quality System data, reporting Key Performance Indicators to management and/or customers.
• Identify areas of greatest need or opportunity for improvement and 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 evaluate training assignments and plans for the electronic Learning Management system, addressing training compliance issues.
• Participate in Vendor Risk Assessments in partnership with Information Security and Procurement, assisting in managing and remediating identified risks.
• Assist HR and IT with employee onboarding and orientation.
• Perform other duties as assigned.

Requirements

• Bachelor’s degree or equivalent in a science, quality, healthcare, or related field.
• 5-7 years of experience in quality systems management, including at least 3 years leading internal, third-party, client, and/or regulatory audits and cross-functional teams/projects at an enterprise scale.

Skills

• One or more of the following certifications is desired: Lean/Six Sigma Green Belt or Black Belt (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).

Benefits

• Comprehensive medical, dental, vision, life, and disability insurance.
• Participation in the company’s 401(k) plan with employer contributions where applicable.
• Flexible paid time off (PTO) policy covering sick days, personal days, and vacations, with eight standard company holidays and three floating holidays annually.

Pay

Posted Salary Range: USD $54,300.00 – USD $89,400.00 per year. This position offers opportunities for a bonus or commissions, with total compensation varying based on factors such as location, relevant skills, experience, and capabilities.