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)