Manager, Quality Clinical Svc

Responsibilities

• Plan, direct, and coordinate quality activities for a clinical customer-focused team to ensure goals are met within budget and timeframe
• Supervise, coach, and develop a team of Quality Specialists and Quality Coordinators
• Perform workload analysis to manage headcount and ensure delivery on customer and business commitments
• Establish quality team goals in alignment with customer requirements and business objectives
• Facilitate daily team performance to build a culture of safety, quality, and continuous improvement
• Provide support for customer audits, visits, and conference calls
• Oversee investigations, consumer complaints, CAPAs, and DEA activities
• Collaborate with Account Executives and Project Managers to facilitate customer Quarterly Business Reviews
• Provide proactive quality assurance and risk assessment using FMEA, HACCP, and Quality by Design
• Ensure strict adherence to PCI, cGMP, and GCP policies and regulations

Requirements

• Bachelor's Degree in a related field and/or 7-10 years of related experience and/or training
• Statistical and advanced mathematical skills
• Advanced computer skills with the ability to operate various complex programs
• Full professional proficiency in speaking, reading, and writing
• High reasoning skills to solve practical problems and interpret various instructions

Preferred Qualifications

• Experience in project accomplishment

Benefits

• Competitive salary and eligibility for an annual 10% performance bonus
• Paid time off
• Health insurance coverage, including dental and vision
• Flexible spending account
• 401(k) plan

About the Company

PCI Pharma Services is a global provider of services to the biopharma industry, acting as a bridge between life-changing therapies and patients. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.