Manager, Quality Clinical Services

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.

Summary of Objective:
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 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.

1. Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition.
2. 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.
3. Establish quality team and individual goals and objectives in alignment with Clinical Customer Focused Team goals and customer requirements.
4. Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best
practices with other Clinical Quality Managers and leadership.
5. 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.
6. Manage the training and development of the team including cross training initiatives and on-boarding of new employees to the team.
7. Provide support for customer audits, visits and conference calls. Work with Clinical Customer Focused Team to develop systemic corrective actions to any deviations noted.
8. Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc.
9. Collaborate with the other team members to manage the team performance metrics and customer scorecard.
10. Collaborate with the appropriate Account Executive and Sr. Project Manager to coordinate and facilitate the
customer Quarterly Business Review's.
11. Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design.
12. Adherence to PCI and cGMP policies, procedures, rules and regulations.
13. This position may require overtime and/or weekend work.
14. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
15. Attendance to work is an essential function of this position
16. Performs other duties as assigned by Manager/Supervisor.

Supervisory Responsibilities: Carries out supervisory responsibilities in accordance with the organizations policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
- Supervises 1-10 employees

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: 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... 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.