Global Quality Assurance Supervisor (Horsham, PA)

Job Purpose:

The Global Quality Assurance Supervisor will assist the Associate Director Global

Quality Assurance in establishing, implementing, and maintaining the Quality

Management System across Ancillare facilities.

Duties and Responsibilities:

• In collaboration with the Associate Director Global QA, Department Subject

Matter Experts (SMEs) and the Responsible Person (RP) to develop, review,

revise and deploy Standard Operating Procedures (SOPs), Functional

Trainings (FTs) and associated documents.

• Work actively with all departments across all line of business in ensuring

Quality Assurance.

• Investigate and document Issues, Deviations, Complaints and CAPAs.

• Manage and maintain Quality documentation files in both hardcopy and

electronic format.

• Develop, review and maintain Change Control documentation.

• Review and approve Batch Record documentation related to kitting jobs.

• Assist in the development & deployment of the Internal Audit program.

• Perform data analysis to identify systemic root causes and Corrective and

Preventive Actions that result in quality improvements.

• Support external audits (e.g., customer, regulatory).

• Effectively partner with and motivate employees and consultants in all

organization departments to implement processes and achieve goals with

respect to quality of products and services.

• Manage and maintain Quality metrics for the organization.

• Work outside normal business hours as may be needed, including

participating in off-hour global calls.

• Possess the ability and desire to work a project to completion, meeting and

or exceeding timeline deliverables.

• Demonstrate and drive the Ancillare mission, values and strategy.

• Participate and contribute positively to process improvement initiatives.

• Work off hours in support of global workforce.

• Travel internationally and domestically as may be required.

• Perform other duties as assigned.

Qualifications:

• Minimum of five-years’ experience in a Quality Assurance/Control role.

• University degree required, may consider equivalent experience.

• Hands-on effective experience managing and maintaining electronic Quality

Management System/s.

• Hands-on experience performing audits – both internal and external

• Hands-on experience participating in the facilitation of regulatory and/or

sponsor inspections.

• Prior successful experience leading or supervising a team.

• Recent working experience with ZenQMS preferred.