Manager, Quality

Work Schedule: First Shift (Days)

Environmental Conditions

• Adherence to all Good Manufacturing Practices (GMP) and Safety Standards
• Office environment
• Some degree of PPE (Personal Prote Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.)

About the Role

CTD partners with pharmaceutical and biotech customers around the world to ensure the right patients get the right therapies in the right doses at the right time. Our services include project management, packaging, distribution, transportation management, specialty logistics, ancillary supply management, clinical supply optimization, and bio-repository storage. Our more than 3,000 employees in over 15 countries work hard every day knowing that what they do matters.

Responsibilities

• Management of a team of Technical Writers/Investigators responsible for managing Quality Records (Investigations, CAPAs, Change Controls, Audit Records, APRs) across Commercial, Clinical, Supply Chain, and Client Services functional areas
• Serve as the Site’s Global Trackwise Administrator, including generation of quality metrics and reports
• Analyze, track, and trend quality system metrics to support Senior Management with quality improvements
• Perform statistical analysis such as regression, clustering, and hypothesis testing to uncover patterns in data using programming languages
• Track non-conformances and complaints, presenting metrics to Senior Management on a scheduled basis
• Serve as a resource on regulatory issues, compliance, and internal investigations
• Conduct data analysis and visualization to make actionable recommendations for Quality presentations
• Serve as quality lead for all client-requested data and reporting needs from a site perspective
• Create reporting and recommended actions for follow-up on past due Quality Action Items such as Investigations
• Assist and make recommendations with drafting and revising QA documents and Standard Operating Procedures (SOPs) as required
• Conduct all activities in a safe and efficient manner
• Apply Good Manufacturing Principles in all areas of responsibility
• Track and, when necessary, author Investigations, Audit records, and Annual Product Reviews
• Generate, track, trend, and report a large set of quality metrics relating to CTD-Allentown business operations and associated clients for continuous improvement purposes, including:
  • Quality Council Metrics Tier 2 Data
  • Client-Specific Metrics
  • Global Metrics
  • New Product Introductions
  • State License Status and adherence
• Track open records in TrackWise (Deviations, Complaints, CAPAs, observations, APRs, and Change Controls) to closure
• Manage workload distribution of writers to cover both Commercial and Clinical Operations and Supply Chain to ensure timely closure of Trackwise records
• Support Commercial Operations by authoring investigations to support timely batch release as needed
• Compile and create presentations for local, global, and client business and quality reviews
• Identify and implement continuous improvement initiatives within the site Quality System business processes

Requirements

• Bachelor’s degree, preferably with a technical or life sciences focus; statistics background preferable
• 5+ years of experience performing data management, data analytics, or data visualization in one of the following industries: Clinical research organization, technology consulting firm, pharma, medical device, or biotech organization
• Experience in GMP and pharmaceutical Quality systems
• In-depth analytical thinking and understanding of metrics management
• Strong technical writing and authorship skills
• Experience in authoring investigations, CAPAs, change controls, and audit responses
• Management experience of direct reports

Skills

• Ability to effectively prepare reports, presentations, metrics, and communications with interpretation of data analysis
• Strong decision-making, relationship-building, problem-solving, planning, and organizing skills
• Independent mindset
• Excellent verbal and written communication skills
• Understanding of clinical and commercial packaging and distribution processes
• Awareness of regulatory documentation requirements
• Mastery of skills required to read, understand, and adhere to SOPs and policies in a GMP environment

Physical Requirements

• Administrative position in an office environment
• Requires standing, bending, reaching, walking, and talking
• Exerting up to 20 lbs. of force occasionally