Associate Clinical Quality Manager II

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title:

Associate Clinical Quality Manager II

Department/Group:

Clinical QC

Location:

Assembly

Reports to:

Clinical Quality Manager

FLSA Status:

Exempt

Prepared By:

Stephanie Powless

Date:

8/23/2022

Approved By:

Sheri Mace

Date:

8/23/2022

Summary of Objective:

Responsible for leading efforts in planning, directing, and coordinating customer Quality activities in order to ensure that the quality of PCI’s products are in compliance with customer requirements as well as state and federal regulations. Lead and play an integral part in individual project success and provide PCI a competitive advantage in long-term customer management.   

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Responsible for creating, routing internally and obtaining customer approval of batch records and packaging material and distribution specs. On time and accuracy are essential to the Clinical Services business model as patient supply cannot be compromised. Customer contact for quality activities and management of customer expectations. Lead Quality improvement projects both within Quality departments and in cross-functional team environments Actively schedules, participates and attends conference calls and customer meetings; CPT and other special project meetings for all assigned projects as needed. Act as a company liaison with customers concerning quality control documentation. Help identify, communicate, track and resolve document related issues with other departments and customers. Assist with generating and presenting quality related metrics and key performance indicators for team’s performance. Assist with addressing and documenting quality events with Production and Quality teams. Assist with training, developing, and mentoring new Quality Specialists and ACQM’s. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Audit participation as needed. Develops, writes, revises and reviews work practices and forms in accordance with PCI and GMP requirements. Verifies changes adhere with SOP's, WP's and customer requirements. Serves as company liaison with customers, PCI US internal departments, PCI UK and Qualified Persons (QP’s) concerning quality control batch release documentation, investigations, complaints and CAPA’s. Responsible for ensuring CAPA’s effectiveness and timeliness. Writes, coordinates and maintains Quality related investigations and complaints, including but not limited to, Events, Deviations, Complaints and customer specific investigations on time and obtaining customer approvals. Writes and/or reviews Temporary Exception Reports for packaging, receiving and distribution. Performs other duties as assigned by Manager/Supervisor. May include travel for Quality Business Review Meetings. Attend customer visits as necessary Review and approve internal and customer based specifications for component and processes. Meet with Management to address issues or concerns with deviations. Responsible for completing training on time. Schedule, host and lead meetings to develop, implement and / or update Batch Records, Material Specifications, Forms, Work Practices and Standard Operating Procedures. Perform expiration updates as needed.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: From 1/4 to 1/2 of the day.