Quality Account Manager

PCI Pharma Services•Philadelphia, PA

About The Position

The Quality Account Manager leads the quality activities of a designated Customer Focused Team, ensuring products and processes meet site quality standards and customer requirements. The role plans, directs, and coordinates team activities to meet objectives within prescribed time frames and budgets, while partnering with the Business Unit Manager to deliver quality products on time. The manager selects, supervises, coaches, develops, and retains team members, and drives project success and long-term quality customer management. The position oversees quality operations and team performance, supports customer audits and visits, manages investigations and corrective actions, and promotes risk-based quality assurance and continuous improvement. It also coordinates quality documentation and batch-record processes to support production schedules and product release commitments. The role directly supervises up to 5–10 associates and performs employee-management responsibilities in accordance with company policies and applicable laws.

Requirements

Bachelor’s degree from a four-year college or university.
Seven to ten years of related industry experience in increasingly responsible positions.
Direct experience working with domestic and foreign regulatory authorities and supporting inspections.
Excellent computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, and Project.
Working knowledge of GMPs and familiarity with International Conference of Harmonization technical requirements, especially ICH Q9, A Risk Based Approach to Quality.
Experience in multiple areas of Quality, such as Incoming Quality Assurance (IQA), Quality Operations, metrology, and validation.
Strong interpersonal and communication skills.
Ability to read, analyze, and interpret scientific and technical journals, financial reports, and legal documents; respond to inquiries or complaints; and present information effectively to management, customers, public groups, and boards of directors.
Ability to work with probability, statistical inference, geometry, trigonometry, fractions, percentages, ratios, and proportions.
Ability to solve practical problems with limited standardization and interpret written, oral, diagrammatic, or scheduled instructions.
Ability to attend work and inspire and lead a team.

Nice To Haves

A history of project accomplishment and leadership excellence.
Lean, Six Sigma, or process-improvement experience.
Lean Six Sigma Black Belt.

Responsibilities

Select, supervise, empower, coach, develop, and retain qualified team members through employee development, performance management, succession planning, and recognition.
Analyze workload and manage team structure and headcount to meet customer and business commitments.
Establish team and individual quality goals aligned with Customer Focused Team objectives and customer requirements.
Coordinate with other business units and functional groups, and collaborate on best practices with other Quality Account Managers and leadership.
Facilitate daily team performance and promote safety, quality, performance, customer service, and continuous improvement.
Manage team training and development, including cross-training and onboarding.
Support customer audits, visits, and conference calls, and work with the Customer Focused Team to develop systemic corrective actions for deviations.
Participate in and oversee investigations, consumer complaints, CAPAs, DEA activities, and non-conformances.
Manage team performance metrics and customer scorecards with other team members.
Coordinate customer Quarterly Business Reviews with the appropriate Account Executive and Business Unit Manager.
Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design in compliance with PCI and cGMP requirements.
Manage development of Master Packaging Instructions for products introduced to the team and updates to new and existing instructions.
Oversee timely issuance and review of batch records to meet production schedules and customer product-release commitments.
Improve team metrics, including reducing batch-record errors to achieve RFT over 99% and avoiding overdue CAPAs, customer complaints, and DNs.
Participate in the batch-record redesign project to standardize documentation.
Ensure adherence to supply agreements, quality agreements, PCI policies, and applicable cGMP requirements.
Manage team budgets and understand the financial implications of team decisions.
Perform supervisory duties including interviewing, hiring, training, staffing, planning, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints, and resolving problems.
Perform other duties as assigned by the supervisor or manager.