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.

Position Title: Manager, Clinical Quality Svc

Location: Assembly Drive, Rockford, IL 61109

Responsible for managing daily operations of the Clinical Quality Operations and Clinical Quality Documents Departments through the activities of the Supervisors, Leads, Inspectors and Document Coordinators. Responsible for the quality issues/events that occur. Plans, directs, and coordinates Quality activities to ensure that goals and objectives are accomplished within prescribed time frames and in budget. Select, supervise, empower, coach, develop and retain a team of qualified individuals. 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.

• Provide knowledge, training, leadership, motivation, and guidance to ensure staff have a clear understanding of tasks, responsibilities, business goals and customer demands.

• Provide 24-hour support for Quality related issues either by phone or email.

• Be observant of processes, performance, and behaviors, focusing on continuous improvement.

• Manage budgets and plans for business growth.

• Compile, analyze and report key departmental Quality metrics (Product HOLDs, Line Clearance Observations/Failures, Near Miss events and Right First Time metrics).

• Provide support via emails, phone, conference calls, Quarterly Business Review/meetings, tours, audits and investigations.

• Perform and participate in tours of functional areas for internal, customer and regulatory audits. Identify risks, observations, and controls. Communicate results and develop action plans to resolve issues.

• Ensure Quality issues are resolved appropriately and report results to Quality and Production Management.

• Oversee incoming, in-process and finished goods inspections of products to ensure conformance to established standards.

• Investigate root causes of quality events/defects and recommending solutions.

• Manage non-conforming product, materials and reports (NMRs, Product HOLDs, Line Clearance Failures).

• Manage Batch Record Right First Time program.

• Ability to partner and collaborate with functional departments.

• Primary Quality Contact for Project Management regarding operational issues.

• Oversee retention of PCI, customer retain samples (retain cage) and outbound retain shipments.

• Lead and drive improvement / harmonization initiatives across multiple facilities.

• Ensure Performance Metrics (Safety/Quality/Regulatory/Delivery), goals and objectives are on track for completion.

• Report and escalate to Senior Management of any potential risks that impact Quality.

• 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.

• 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.

• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.

• This position may require overtime and/or weekend work.

• Attendance to work is an essential function of this position

• Performs other duties as assigned by Manager/Supervisor

• Deliver MRO parts to PRTs on the lines in a timely fashion. Create Work Orders to document repair, time and parts issued.

• Assist in determining needed parts that are not stocked, coordinate expedited delivery if necessary. Determine appropriate stocking levels.

• Work with vendors on parts that need recoating/re-rubbering/repairing. Also work with vendors who accept old parts as trade in. Coordinate with radio vendor on repairs/warrantied work. Ensure scrap material is picked up in a timely manner.

• Make vinyl, and engraved signs per internal customers instructions. Maintain stock levels of all needed sign supplies. Make Asset Tags as requested.

• Assist in receiving stock items with entry to system, replenishment of shelves.

• Perform routine spare parts cycle counting on a weekly basis.

• Perform Maintenance and repair on gearboxes, glue nozzles and other repairable equipment. Coordinate with Machine Shop on sharpening of all blades.

• 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.

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 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.

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.