at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
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,andcoordinatesQualityactivitiesofa designatedClinicalCustomerFocusedTeamtoensurethat goalsandobjectivesoftheteamareaccomplishedwithinprescribedtimeframesandinbudget.Select,supervise, empower,coach,developandretaina teamofqualifiedindividualsincluding:QualitySpecialist(s)andQuality Coordinator(s)whilepartneringwiththeSr. ClinicalProjectManagertoensurethat wedelivera qualityproduct,on time.DrivesprojectsuccessthroughactiveleadershiptoprovidePCIa competitiveadvantageinlong-termquality customermanagement.
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 requirements.
Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best
practices with other Clinical Quality Managers and leadership.
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 team.
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 Review's.
Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design.
Adherence to PCI and cGMP policies, procedures, rules and regulations.
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
Performs other duties as assigned by Manager/Supervisor.
Supervisory Responsibilities:
-Supervises1-10employees
Special Demands:
- 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: Up to 1/4 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 1/2 to 3/4 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.
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 Requirements
Work Environment:
The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
Workisprimarilyperformedata deskand/orinanofficeenvironment. for 3/4ofthedayandup.
Thenoiselevelintheworkenvironmentistypically, moderate.
Qualifications:
Required:
- 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 professional needs.
- High Reasoning: Ability to... For full info follow application link.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.
