Business Process Excellence and Quality Manager

Job Purpose:

The Business Process Excellence & Quality Manager is responsible for supporting Quality Issues and Audits for the Consulting organization, along with supporting and managing related business processes and compliance, regulatory inspection readiness, Quality Plans, and continuous improvement projects.

Manage process excellence

• Support operational and leadership staff in developing, updating, and improving written standard methodologies (process and guidance documents) for Consulting service offerings.

Manage client/internal audits and regulatory inspections

• Function as host for audits, as assigned.

• Provide audit/inspection support to project teams and Consulting Quality colleagues.

• Represent Consulting in audits/inspections.

• Support functional audit preparation and facilitation, and response to queries from auditors.

Manage Quality Issue Management

• Identify Quality Issues with operational staff.

• Collaborate with staff to meet timelines for opening and closing quality issues.

• Manage, follow-up, conduct root cause analysis and CAPA determination.

• Support development of Quality Agreements and Partnership manuals in a cross-functional capacity.

• Work closely with the business providing the expertise and guidance to close all CAPAs on time and correctly.

• Support development of Quality Agreements and Partnership manuals

Support trending analysis and metrics

• Support project compliance and client survey results, as assigned.

• Support appropriate quality metrics, ways of collection and reporting.

• Share trends, identify process/quality gaps.

• Propose process improvements with required Consulting teams as well as cross-departmental.

Skills:

• Excellent interpersonal, verbal, and written communication skills.

• Customer-focused approach to work.

• Ability to work fully independently, take initiative, and have a flexible approach with respect to work assignments.

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with diligence and strong organizational skills.

• Culturally aware and able to think and work globally.

• Ability to travel as needed for the position.

• Ability to work flexible hours to accommodate multiple time zones.

• Demonstrated skills in training development and delivery a plus.

Knowledge and Experience:

• Relevant experience in the industry (e.g., in the pharmaceutical or CRO industry).

• Knowledge of process management.

• Excellent and demonstrated understanding and knowledge in quality assurance or quality management, audit/inspection process and quality issue management.

• English proficiency (written and oral English).

• IT literate: experienced with Microsoft based applications, particularly excellent Microsoft Excel skills including knowledge of formulas, pivots, look up tables and chart generation.

Education:

Educated to degree level in industry related discipline (technology, biological science, pharmacy, or other health related discipline preferred) or equivalent qualification or clinical research experience.