Quality Account Manager

PCI Pharma Services•Philadelphia, PA

About The Position

The Quality Account Manager is responsible for ensuring quality products and processes by aligning a customer-focused team with the site’s approved quality standards. The role plans, directs, and coordinates the team’s Quality activities to achieve its goals within prescribed time frames and budget. In partnership with the Business Unit Manager, the Quality Account Manager leads and develops qualified team members, supports customer quality management, and drives project success. The position oversees team performance, training, staffing, audits, investigations, corrective actions, quality metrics, customer reviews, risk assessments, and packaging and batch-record documentation. It promotes continuous improvement and ensures compliance with applicable supply and quality agreements, PCI policies, and cGMP requirements. The role directly supervises up to 5–10 associates and carries out related hiring, training, performance management, and employee relations responsibilities.

Requirements

Bachelor’s degree from a four-year college or university.
Seven to ten years of related industry experience in increasingly responsible positions.
Experience supporting inspections and working directly with domestic and foreign regulatory authorities.
Experience in multiple Quality areas, such as Incoming Quality Assurance, Quality operations, metrology, and validation.
Working knowledge of GMPs and familiarity with International Conference of Harmonization technical requirements, especially ICH Q9.
Excellent computer skills, including Microsoft Word, Excel, PowerPoint, Outlook, and Project.
Strong interpersonal and communication skills, including the ability to interpret technical, scientific, financial, and legal materials; respond to customer, regulatory, and business inquiries; and present information to management, customers, public groups, or boards.
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 schedule-based instructions.
Ability to lead a team; attendance is an essential aspect of the job.

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 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 goals aligned with Customer Focused Team goals and customer requirements.
Coordinate with other business units and functional groups, and share best practices with Quality Account Managers and leadership.
Facilitate daily team performance and foster a culture of 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.
Work with the Customer Focused Team to develop systemic corrective actions for identified 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 and facilitate 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 applicable policies and 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 quality metrics, including reducing batch-record errors to achieve RFT over 99% and avoiding overdue CAPAs, customer complaints, and DNs.
Contribute to the batch-record redesign project to standardize documentation.
Ensure adherence to supply agreements, quality agreements, PCI policies, and applicable cGMP policies, procedures, rules, and regulations.
Manage team budgets and understand the financial implications of team decisions.
Carry out supervisory responsibilities, including interviewing, hiring, training, staffing, assigning and directing work, appraising performance, rewarding and disciplining employees, addressing complaints, and resolving problems.
Perform other duties as assigned by the Supervisor/Manager.