Quality Supervisor, Complaints

PCI Pharma Services•Philadelphia, PA

About The Position

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. The Complaints Quality Supervisor has the primary function of supervising the team that was conducting customer complaint investigations. The individual also performs support functions related to maintaining the overall Quality Management System.

Requirements

Supervisory experience is required for the role. Team size 3-6 and growing.
Experience with Quality Management Systems (i.e. APQRs, internal audits, CAPA effectiveness, change control)
Bachelor's Degree in a related field (Scientific) and/or 1-5 years related experience and/or training.
Prior experience in technical writing and utilizing root cause analysis tools is required
The candidate must be able to demonstrate basic proficiency with personal computers, business software (e.g., MS Office) and technical software (e.g., TrackWise).
Ability to create, use and interpret scientific tables, charts, and graphs.
Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
Problem solving skills along with a strong collaborative approach is required.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization.

Nice To Haves

Lean Six Sigma or process improvement experience
Ability to effectively present information to various people as the job requires.
Ability to identify and resolve problems in a timely manner.
Ability to show success in managing employees.

Responsibilities

Supervise the team involved in the intake, drafting, and closure of customer complaints
Collaborate with internal departments to effectively communicate with other customers
Capable of resolving complex issues through collaboration with internal and external parties
Represent PCI on customer calls related to customer complaint investigation
Receive communications from customers related to complaints
Log complaints into the QMS system
Conduct investigations utilizing root cause analysis tools and work with other functional areas to identify the cause and appropriate corrective and preventive actions
Draft and peer review customer complaint investigations
Communicate directly with clients in resolution of customer complaints
Compile metrics for the functional area
Assist with compiling information for regulatory filings
Responsibility will include some facets of maintaining and improving the overall Quality Management Systems (i.e. APQRs, internal audits, CAPA effectiveness, change control)