Manager, Quality Clinical Svc

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.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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 solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.

Preferred:

- Project Accomplishment Experience

The hiring rate for this position is $77,600-$87,300 plus eligibility for an annual 10% performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

#LI-SW1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.