Healthcare Quality Assurance Manager
The Healthcare Quality Assurance (QA) Manager communicates and manages quality policy and objectives and reports on the overall effectiveness of the UPS Healthcare quality program.
Job Responsibilities Develop, manage and support people resources and processes Ensure direct and indirect reports have documented career goals
Conducts frequent performance evaluations in a consistent, fair and objective manner
Delivers training
Identifies individual and team skill gaps and developmental opportunities
Hold others accountable to established performance levels to achieve individual and group goals
Resolves individual and group performance issues
Coaches others and provides on-going feedback and support to improve performance
Identifies opportunities to involve others in new and challenging work assignments or rotations that advance the skills of the individual
Make salary recommendations to reward employee performance
Manages staffing levels and manages resource needs in order to meet the business demand.
Risk Management Manages risk assessment & risk minimization of storage, distribution and transportation of healthcare products
Manages and conducts assessments of current SCS capabilities to determine SCS’s ability to meet client requirements and proposes appropriate solutions
Manages licensing and RA appropriate risk assessment procedures and processes to minimize risk
Manages and conducts consultations with Corporate Legal to determine compliance implications of pending business opportunities
Assesses risk and develops corrective and preventive actions (CAPA) to close identified gaps or concerns
Audits and Validation Manages information gathering, scheduling, preparation and distribution of reports to
prepare for internal and client audits
Review and approve audit response to findings for internal and client audits
Manages audit response timeliness and ensures that action items from AIPs are
completed on time.
Manages Corporate Compliance and agency audits to ensure follow up activities are
identified and conducted on time
Manages change controls, training, PACs, audits, audit responses and the writing and
revising of procedures identified as needed
Document Control Process Create, revise, review and approve controlled documents and record templates (e.g., SOP, manuals, work instructions).
Review and approve Quality Agreements
Manage projects
Support growth of new and expanded facilities, clients and services
Support continuous quality management system improvements
Review and approve major and critical nonconformance reports
Evaluates and manages procedures across locations to ensure consistency in content and implementation
Analyzes information on incidents to determine causes and document findings
Identifies patterns or trends among incidents to determine next steps required by type of incident and recommends new approaches to incident investigation and response
Leadership Collaborates with internal groups (e.g., Operations, Business Development (BD), solutions, implementations etc.) to ensure the smooth implementation and running of new healthcare business
Interface with senior management, site management and other internal colleagues
Manage and support development of QA Associate Managers and other staff
Next-level escalation for QA Supervisors and QA Associate Managers
Job Requirements Possess at least a Bachelor’s degree in a Science-related discipline
Possess 5 to 7 years’ experience in pharmaceutical or healthcare industry in a quality related role
Possess strong technical quality and regulatory affairs (QA/RA) knowledge
Prior experience with GMP and/or GDP guidelines
Prior experience with ISO 13485 and 9001 standards
Demonstrate superior people management with prior experience in past roles
Demonstrates a detailed understanding of supply chain concept
Display superior attention to detail
Display positive leadership, influence and negotiation skills
Possess strong written and verbal communications skills
Proficient in Microsoft Office applications (Word, PowerPoint, Excel)