Manager, Quality Clinical Services
Company: Packaging Coordinators, Inc.
Posted on: September 21, 2022
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 Summary:Plans,
directs, and coordinates Quality activities of a designated
Clinical Customer Focused Team to ensure that goals and objectives
of the team are accomplished within prescribed time frames and in
budget. Select, supervise, empower, coach, develop and retain a
team of qualified individuals including: Quality Specialist(s) and
Quality Coordinator(s) while partnering with the Sr. Clinical
Project Manager to ensure that we deliver a quality product, on
time. Drives project success through active leadership to provide
PCI a competitive advantage in long-term quality customer
management.Essential Duties & Responsibilities:
- Select, supervise, empower, coach, develop and retain a team of
qualified individuals through effective employee development,
performance management, succession planning and recognition.
- Ensure the appropriate team structure is in place by performing
workload analysis to manage headcount and to ensure we deliver on
customer and business commitments.
- Establish quality team and individual goals and objectives in
alignment with Clinical Customer Focused Team goals and customer
- Ensure strong alignment and coordination with other business
units and functional groups. Collaborate on best
- practices with other Clinical Quality Managers and
- Facilitate the daily quality team performance to ensure goals
and objectives are met and to build a culture of safety, quality,
performance, customer service and continuous improvement.
- Manage the training and development of the team including cross
training initiatives and on-boarding of new employees to the
- Provide support for customer audits, visits and conference
calls. Work with Clinical Customer Focused Team to develop systemic
corrective actions to any deviations noted.
- Oversee investigations, consumer complaints, CAPAs, DEA
activities, NMR issues, etc.
- Collaborate with the other team members to manage the team
performance metrics and customer scorecard.
- Collaborate with the appropriate Account Executive and Sr.
Project Manager to coordinate and facilitate the
- customer Quarterly Business Reviews.
- Provide proactive quality assurance and risk assessment using
FMEA, HCCAP, and Quality by Design.
- Adherence to PCI and cGMP policies, procedures, rules and
- This position may require overtime and/or weekend work.
- Knowledge of and adherence to all PCI, cGMP, and GCP policies,
- Attendance to work is an essential function of this
- Performs other duties as assigned by
- Supervises 1-10 employeesSpecial Demands:
- St a t i o n a ry P o s iti o n: From 1/2 to 3/4 of the
- Mov e, T r av e r s e: From 1/4 to 1/2 of the day.
- O per at e, a c t i vat e, u s e, prep a r e , in s pec t , o r
plac e : Up to 1/4 of the day.
- I n s ta ll, plac e , a djust, a p p l y , m e a s ure, u s e,
o r s i g n a l: None.
- Ascend / Desce n d o r W o rk A t o p: None.
- P o s iti o n self (to ) o r M o v e ( a b o ut o r to ) : From
1/2 to 3/4 of the day.
- C o m m u n ic at e o r e x ch a n g e inf o r m at i o n: 3/4
of the day and up.
- De t e ct , di s t ingui s h, o r de t e r m i ne: From 1/4 to
1/2 of the day.On an average day, the individual can expect to move
and/or transport up to 10 pounds between 1/4 and 1/2 of the
day.This position may have the following special vision
requirements. Close Vision Distance Vision Color Vision Peripheral
Vision Depth Perception Ability to focus No Special Vision
RequirementsWork Environment:The following are some environmental
conditions that one may be exposed to on a daily basis and for
various lengths of time.Work is primarily performed at a desk
and/or in an office environment. for 3/4 of the day and up.The
noise level in the work environment is typically,
- Bachelor's Degree in a related field and/or 7-10 years related
experience and/or training.
- Statistical and Advanced Mathematical Skills
- Advanced Computer Skills: Ability to perform the most complex
computer tasks and operate various computer programs.
- Full Professional Proficiency: Ability to speak, read, and
write fluently and accurately on all levels pertinent to
- High Reasoning: Ability to solve practical problems and deal
with a variety of concrete variables insituations where there is
only limited standardization. Ability to interpret a variety of
instructions that may be provided in various forms.Pr ef e r r e d:
- Project Accomplishment ExperienceJoin us and be part of
building the bridge between life changing therapies and patients.
Lets talk future (https://pci.com/)Equal Employment Opportunity
(EEO) Statement:PCI Pharma Services is an Equal
Opportunity/Affirmative Action Employer. We do not unlawfully
discriminate on the basis of race, color, religion, age, sex,
creed, national origin, ancestry, citizenship status, marital or
domestic or civil union status, familial status, affectional or
sexual orientation, gender identity or expression, genetics,
disability, military eligibility or veteran status, or any other
protected status.PCI Pharma Services is an Equal Opportunity
Keywords: Packaging Coordinators, Inc., Rockford , Manager, Quality Clinical Services, Executive , Rockford, Illinois
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